Flu vaccination of pregnant women 2021

Flu vaccination of pregnant women 2021 – 2021

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What's special about this year?

The ongoing pandemic of a new coronavirus infection is combined this year with the circulation of influenza virus strains that people have not encountered for a long time and immunity to which is either absent or very weak. The World Health Organization (WHO) has replaced three components in the recommended influenza vaccines for the 2020-2021 epidemic season in the northern hemisphere, these are A/Guangdong-Maonan/SWL1536/2019(H1N1)pdm09, A/HongKong/2671/2019 (H3N2 ), B/Washington/02/2019 (B/Victoria lineage).

In the speeches of the leaders of WHO and the Russian Ministry of Health, the main argument in favor of the widest possible vaccination against seasonal flu this year runs through: no one knows how the coronavirus will behave once it enters an organism suffering from the flu. Most likely, the patients’ condition will sharply worsen and the prognosis will worsen. This applies most of all to pregnant women who have peculiarities of the immune response.

Thus, it is advisable for all pregnant women who do not have contraindications (there are actually very few of them: an allergy to chicken protein and an acute illness that is currently occurring) to be vaccinated as soon as possible.

Brief information:

Three main reasons to get vaccinated during pregnancy:

A woman during pregnancy is much more at risk of contracting the flu, since her immunity is altered.
In case of influenza infection, the course of the disease in a pregnant woman is much more severe and with complications.
Vaccination of pregnant women against influenza protects mother and her child. A pregnant woman who is vaccinated during pregnancy passes influenza antibodies through the placenta to her fetus. A child born from a vaccinated mother receives immunity for at least 6 months. According to research results, it is known that vaccinating a mother reduces the risk of influenza infection in a newborn child by 63%.

Safety:

According to available data, modern inactivated split vaccines do not have a toxic or teratogenic effect on the body of a pregnant woman and the fetus.

When to vaccinate:

after 14 weeks of pregnancy.

What vaccine?

The Perinatal Health Center will have a large arsenal of influenza vaccines for adults and children this year. To vaccinate pregnant women, only vaccines without a preservative are used. Subunit and split vaccine can be used. In 2021, the Perinatal Health Center received the opportunity to use the most modern vaccine for vaccinating pregnant women, containing components relevant in 20-21 in a dose of 15 mcg, which meets international standards. Vaccines such as Ultrix, FluM, Influvac combine maximum safety due to the absence of an adjuvant and effectiveness due to the internal antigens of the virus presented in split vaccines.

Recommendations:

It would be very correct if all women of fertile age who do not use contraception, and therefore are planning a pregnancy, were vaccinated in advance. This would keep them out of trouble for a year.
It would be very correct if all residents of the apartment where a pregnant woman lives were vaccinated. The risk of infection through close contact is greatest.
Doctors are ready to help if a pregnant woman gets the flu, but it’s better, of course, to stay healthy.

What is the danger of flu during pregnancy?

03.10.2017

Quantity

What is the danger of flu during pregnancy?

The flu causes the greatest harm to the most vulnerable segments of the population, including pregnant women. For example, during the 1957 pandemic, pregnant women died making up 50% of women of childbearing age. The swine flu epidemic in Russia in 2009 claimed the lives of 83 women. The World Health Organization's maternal and child health guidelines prioritize influenza vaccination for pregnant women. The Advisory Council on Immunization Practices (ACIP) recommends seasonal vaccination of pregnant women.

According to the conclusion of the studies, the use of inactivated (killed) influenza vaccines does not have a teratogenic effect on the fetus and does not harm the health of a pregnant woman. So is it possible for pregnant women to get a flu vaccine? Is it dangerous for the unborn child?

During pregnancy, a woman's immunity is weakened and she becomes susceptible to any infection. Most often, an expectant mother may be at risk of becoming infected due to the annual flu epidemic. This disease in a pregnant woman occurs in a more severe form and with complications. This disease is dangerous for a pregnant woman precisely because of its complications:

· pneumonia;

· sinusitis;

· bronchitis;

· otitis media

In severe cases, myocarditis with heart failure may develop. Chronic diseases are getting worse: diabetes, bronchial asthma, bronchitis, nephritis.

Flu in a pregnant woman can also affect the health of the fetus. It is most dangerous in the early stages of pregnancy, when the tissues and organs of the human embryo are laid and formed. Viral intoxication or drug exposure can lead to pathology of the child’s organs. In later stages of pregnancy, there is a risk of infection of the fetus.

Why is it important to vaccinate pregnant women against influenza?

During pregnancy, the expectant mother worries not only about her health, but also about whether the baby will be born healthy and strong. And it is quite natural that expectant mothers often wonder whether or not to get vaccinated.

Important reasons to get vaccinated are as follows.

1. A woman during pregnancy is much more at risk of contracting the flu, since her immunity is weakened.

2. In case of influenza infection, the course of the disease in a pregnant woman is much more severe and with complications.

3. Vaccination of pregnant women against influenza protects the mother and her child. A pregnant woman who is vaccinated during pregnancy passes influenza antibodies through the placenta to her fetus. A child born from a vaccinated mother receives immunity for at least 6 months. According to research results, it is known that vaccinating a mother reduces the risk of influenza infection in a newborn child by 63%.

Pros and cons of flu shots for pregnant women

Currently, there is no consensus in the medical community about whether pregnant women should be vaccinated against influenza. Doctors who recommend vaccination explain its necessity with the following reasons.

1. If infected with influenza, the disease in a pregnant woman can be severe and with complications.

2. A severe form of influenza can lead to miscarriage or termination of pregnancy.

3. Viral intoxication of the mother can cause developmental abnormalities or delays in the physical or mental development of the child.

4. A vaccinated pregnant woman herself is protected from infection and passes on the protection to her newborn child within several months.

Doctors who refrain from using vaccinations give the following reasons.

1. The vaccine does not provide a 100% guarantee of the formation of immunity.

2. Like any medical product, the vaccine has a risk of adverse reactions.

Should a pregnant woman get a flu shot or not? It is best to make this decision together with your doctor. After all, in each specific case the conditions are not the same. If a flu epidemic is inevitable and a pregnant woman has no contraindications, then the vaccine should be given. If a pregnant woman has a negligible risk of infection, she does not come into contact with a large number of people, or is opposed to vaccination, then you don’t have to do it. After consulting with your doctor about such a vaccination, you can come to the optimal decision.

Contraindications for vaccination during pregnancy

An acute respiratory disease or exacerbation of any other chronic disease has temporary contraindications - vaccination is postponed until recovery.

General contraindications for pregnant women to get a flu shot are as follows:

Allergy to chicken eggs, antibiotics;

· individual intolerance to the vaccine;

· allergic reaction to a previous vaccination;

· first trimester of pregnancy.

When is it recommended to vaccinate pregnant women?

When planning a pregnancy, the flu vaccine should be taken into account in advance in order to protect mother and baby from infection in the future. Vaccination is especially indicated for pregnant women suffering from chronic diseases (diabetes mellitus, nephritis, bronchitis). This category of people is especially susceptible to severe disease if infected.

When to vaccinate?

1. Seasonal prevention of influenza is carried out in September and October. Vaccinations for pregnant women are recommended from the second trimester of pregnancy.

2. During a planned pregnancy, a flu shot is given 1 month before it.

3. Flu vaccinations before pregnancy are planned on the basis that the formation of immunity occurs within 2–4 weeks. Protection after vaccination lasts about a year.

Rare side effects from vaccination

Current flu vaccines are safe for pregnant women. But sometimes serious consequences can still arise.

1. Anaphylactic shock, accompanied by a sharp drop in the mother’s blood pressure. The resulting oxygen starvation of the fetus may require termination of pregnancy.

2. An allergic reaction in a severe dangerous form of Quincke's edema.

3. Development of allergic reactions in a newborn child.

How can a pregnant woman prepare for vaccination?

An expectant mother, knowing how a flu shot can affect pregnancy, should consult a doctor about the upcoming vaccination. If a woman has previously had an allergic reaction, especially to chicken protein and antibiotics, be sure to inform the doctor about this.

1. On the day of vaccination, the expectant mother must be healthy.

2. 2 weeks before the appointment she should not have suffered any infection.

3. A few days before vaccination, you need to exclude unusual foods from your diet.

Which vaccine should I choose?

According to available data, modern inactivated split vaccines do not have a toxic or teratogenic effect on the body of a pregnant woman and the fetus. The most harmless vaccines contain a minimum of harmful substances. These include:

· “Influvac” produced by the pharmaceutical company Solvay Pharmak (Netherlands);

· "Begrivac" made in Germany, Novartis Vaccines and Diagnostics;

· "Vaxigrip" manufactured by Sanofi Pasteur (France);

· "Sovigripp" made in Russia, produced by the pharmaceutical company NPO Microgen;

· "Grippol Plus" produced in Russia by NPO PETROVAX PHARM.

· If you choose between the two latest domestically produced vaccines, then Sovigripp is better suited for pregnant women, as it does not contain a preservative.

· To summarize, we note that vaccination provides protection for the mother and her fetus throughout pregnancy. A child from a vaccinated mother receives antibodies through the placenta, and after birth also receives them through milk. Over many years of use in Russia and abroad, all influenza vaccines have proven safe for mother and fetus. They can also be used during lactation.

Centers for Disease Control and Prevention (CDC) Guidelines

The official website of the CDC states that “vaccination is the first and most important task for protection against influenza”, “vaccination during pregnancy protects both mother and child”, “vaccination reduces the mother’s risk of contracting influenza by almost half” [11]. Below is a list of sources. Let's start analyzing them.

Among the six scientific articles confirming the above statements, there are 4 RCTs. Let's start with the most recent.

Study “Year-round influenza vaccination of pregnant women in Nepal” (Steinhoff, 2017) [12].

The study involved 3,693 pregnant women between 17 and 34 weeks of pregnancy.
The experimental group - 1847 people - received a trivalent influenza vaccine, the control group - 1846 people - received a placebo (saline solution). The purpose of the study was to determine the effect of vaccination of pregnant women against influenza on the number of cases of confirmed influenza in their newborn children in the first 180 days of life and to determine cases of acute respiratory viral infection in the mother (before and after birth).

What results do the authors claim?

Vaccination helps reduce the incidence of acute respiratory viral infections in women by 19% (95% CI 1-34) and reduce the incidence of confirmed influenza in newborns by 30% (95% CI 5-48).

What do these results mean?

Vaccination of a pregnant woman protects every 42 vaccinated pregnant women, more precisely, every 22-146 (NNV=42, 95% CI 22-146) from ARVI and every 60 newborn children, more precisely, every 33-333 (NNV=60, 95% CI 33 -333) from the flu.

Study “Vaccination of pregnant women with trivalent influenza vaccine for the prevention of influenza among newborns in Mali” (Tapia, 2016) [13].

The study participants included 4,192 pregnant women more than 28 weeks pregnant.
The experimental group (2108 people) received a trivalent flu vaccine, the control group (2085 people) received a meningococcal vaccine. The purpose of the study was to determine the effect of vaccination of a pregnant woman against influenza on the incidence of laboratory-confirmed influenza among newborns.

What results do the authors claim?

Vaccination of a pregnant woman against influenza reduces the incidence of influenza among children in the first 6 months of life by 33.1% (95% CI 3.7-53.9) compared with vaccination against meningococcal infection.

What do these results mean?

Vaccination of the mother during pregnancy protects every 82 children from influenza, or more precisely, every 31–454 (NNV=82, 95% CI 31–454).

Study “Vaccination of pregnant women against influenza and protection of children” (Madhi, 2014) [14].

The work consists of two studies: determining the effectiveness of vaccination in HIV-uninfected women and HIV-infected women who are 20-36 weeks pregnant.
Both studies were conducted in South Africa (Soweto). HIV-uninfected women in the experimental group (1062 people) were administered a trivalent influenza vaccine, and in the control group (1054 people) a placebo (saline solution) was administered.

The purpose of the study is to determine the effect of vaccination of a pregnant woman on the morbidity of the child in the first 6 months of life.

What results do the authors claim?

Vaccination of a pregnant woman had an impact on reducing the incidence of influenza in women by 50.4%: 1.8% of cases were registered in the experimental group and 3.6% in the control group and in their children by 48.8% - 1.9% of cases were registered in the experimental group and 3.6% in the group control.

What do these results mean?

Vaccination of a pregnant woman reduces the incidence of influenza in every 56 mother, more precisely, in every 31-233 (NNV=56, 95% CI 31-233) and in every 58 child, more precisely, in every 32-286 (NNV=58, 95% CI 32-286).

The fourth RCT in the list of CDC sources is a 2008 study [6], which is mentioned in the WHO recommendations (see analysis above).

It is worth noting that all of the above studies were supported by the Bill and Melinda Gates Charitable Foundation. Many authors of publications have conflicts of interest with pharmaceutical companies/vaccine manufacturers.

Conclusion

The recommendations from the Centers for Disease Control and Prevention are unsubstantiated, and all the studies cited as sources, rather, confirm the opposite.

CDC statements that vaccinating a pregnant woman against influenza protects the mother and her child are also unreliable [7] - as you can see, only every 42-56 vaccinated mother and every 58-60-82nd child of a vaccinated mother receives protection. And in addition, an imaginary sense of security can reduce vigilance regarding non-specific prevention of respiratory infections: avoiding contact with infected people, observing cough and sneeze etiquette, regular hand washing, etc.

The only thing is that the CDC recommendations indicate that vaccination reduces the risk of influenza in the mother by up to 50%. Indeed, this is shown in the Madhi study - the incidence of influenza decreased from 3.6% to 1.8%, and in fact, every 56th mother receives protection.

Vaccinations

Yazbak Edward Fouad (1931-2021) - MD, pediatrician specializing in infectious diseases, member of the American Academy of Pediatrics. Since 1993, he has been researching autoimmune regressive autism and the harm caused by vaccinations.

Original here

“In the United States, flu vaccination is now widely recommended in any trimester of pregnancy. We performed a critical review of the CDC's Advisory Committee on Immunization Practices (ACIP) influenza vaccination policies and the sources cited by the authors of the recommendations.” So begins the abstract of a paper Dr. David Ayoub and I wrote, published in the summer issue of the Journal of American Physicians and Surgeons.

Followed by:

Sources used by the Advisory Committee and current literature indicate that influenza illness rarely poses a threat to a healthy pregnancy. There is no convincing evidence that influenza vaccination is effective during pregnancy. There have been no studies that have adequately assessed the risk of such vaccination during pregnancy, nor have there been safety studies in animals. Thimerosal, a mercury-based preservative present in most inactivated forms of the vaccine, is associated with neurological developmental disorders in humans, including autism, and also causes a wide range of reproductive toxicities in animals, including teratogenic and mutagenic effects, and fetal death. Thimerosal is also classified as a human teratogen. Conclusions: The Advisory Committee's recommendations on universal influenza vaccination during pregnancy are unwise, lack scientific support, and should be withdrawn. The use of thimerosal during pregnancy should be considered contraindicated.

This major review, “Influenza Vaccination in Pregnancy: A Critique of the Advisory Committee on Immunization Practices Recommendations,” is the first and only such review not funded by vaccine manufacturers or commissioned by the Centers for Disease Control (CDC) to justify recommending that pregnant women receive an unproven vaccine. effectiveness and safety and currently still contains the mercury preservative thimerosal.

I previously had the pleasure of co-authoring another publication with Ayoub, War of the States: What Happened in Illinois? In this report, we exposed the incredible machinations by which a law that would have banned the use of thimerosal in vaccines, passed almost unanimously (one vote against) by both houses of the Illinois State Legislature, was blocked by the joint efforts of the State Department of Health Services, the Illinois Chapter of the American Academy of Pediatrics and the Center for Disease Control.

Our article in the Journal of American Physicians and Surgeons critically analyzes all the information available to the Advisory Committee, as well as everything that has been published on the subject in the world medical literature. The article provides links to 60 sources.

This publication represents a very limited review of cases reported to the Vaccine Adverse Event Reporting System (VAERS) database associated with influenza vaccination during pregnancy.

It is worth mentioning that both the CDC and the Food and Drug Administration (FDA), which created the VAERS database, like to emphasize that reporting a case to VAERS does not necessarily mean that the vaccine the patient received was the cause of the adverse incident.

The next four cases in this database, all recorded on December 28, 2005, may suggest just the opposite. All four patients were from North Carolina, all received the same parenteral influenza vaccine, and two received doses from the same vaccine series.

Case No. 1

VAERS database identification number: 249829 Date of vaccination: 2005-10-25 Age: 23.0 Date of registration: 2005-12-28 Gender: F Where vaccination was carried out: GOS State: Northern. Carolina Vaccine purchased: Private.

Life threat? No Is the patient dead? No Disability? No Recovery? Yes Call an ambulance or a doctor? No Hospitalization? No Current medical condition: Laboratory tests: Previous vaccinations: Other medications: prenatal vitamins Background medical conditions:
	Vaccines: 1 Flu Lot: U1747 AA Dose: 0 Method of administration: IM Place: Ave. shoulder
	Date of onset of reaction: 2005-11-15 Days after vaccination: 21 Symptoms: STILLBIRTH Intrauterine death of the fetus at 39 weeks 4 days (? problem with the umbilical cord)

This fetus died at 39 weeks and 4 days of gestational age, approximately 21 days after maternal vaccination.

Case No. 2

VAERS database identification number: 249831 Date of vaccination: 2005-11-04 Age: 32.0 Date of registration: 2005-12-28 Gender: F Where vaccination was carried out: GOS State: Northern. Carolina Vaccine purchased: Private.	Life threat? No Is the patient dead? No Disability? No Recovery? Yes Call an ambulance or a doctor? No Hospitalization? No Current medical condition: Laboratory tests: Previous vaccinations: Other medications: prenatal vitamins, iron Background medical conditions:
Vaccines: 1 Flu Lot: U1815 AA Dose: 0 Method of administration: IM Place: Ave. shoulder
Reaction onset date: 2005-12-02 Days after vaccination: 28 Symptoms: UNDEFINED REACTION The patient suffered intrauterine fetal death at 24 weeks 3 days 02/12/05

This fetus died at 24 weeks and 3 days of gestational age, 28 days after vaccination received by the mother.

Case No. 3

VAERS database identification number: 249832 Date of vaccination: 2005-10-26 Age: 21.0 Date of registration: 2005-12-28 Gender: F Where vaccination was carried out: GOS State: Northern. Carolina Vaccine purchased: Private.	Life threat? No Is the patient dead? No Disability? No Recovery? Yes Call an ambulance or a doctor? No Hospitalization? No Current medical condition: Laboratory tests: Previous vaccinations: Other medications: prenatal vitamins, iron Background medical conditions:
Vaccines: 1 Flu Lot: U1747 AA Dose: 0 Method of administration: IM Place: Ave. shoulder
Date of onset of reaction: 2005-11-25 Days after vaccination: 30 Symptoms: Spontaneous premature stillbirth Patient delivered a stillbirth on 11/25/05 gestational age 32 weeks 5 days (Sister Thompson Allison)

This baby was stillborn 30 days after the mother's vaccination at 32 weeks and 5 days.

Case No. 4

VAERS database identification number: 249833 Date of vaccination: 2005-10-26 Age: 18.0 Date of registration: 2005-12-28 Gender: F Where vaccination was carried out: GOS State: Northern. Carolina Vaccine purchased: Private.	Life threat? No Is the patient dead? No Disability? No Recovery? Yes Call an ambulance or a doctor? No Hospitalization? No Current medical condition: Laboratory tests: Previous vaccinations: Other medications: prenatal vitamins Background medical conditions:
Vaccines: 1 Flu Lot: U1836 AA Dose: 0 Method of administration: IM Place: Ave. shoulder
Date of onset of reaction: 2005-11-16 Days after vaccination: 21 Symptoms: REACTION UNDERSTANDING. Intrauterine death of the patient's fetus at 27 weeks 3 days (11/21/05) Sister Ivy, Heather

Fetal death occurred 21 days after maternal vaccination, at 17 weeks and 3 days.

So:

All four North Carolina cases were reported to VAERS on December 28, 2005.
In the first case, the mother received the vaccine on October 25, 2005.
In the remaining three cases, vaccinations were given on October 26, 2005.
All four received the Fluzone vaccine produced by Sanofi Pasteur.
In cases No. 1 and No. 3, the vaccine was obtained from the same series
In all cases, intrauterine fetal death occurred 3–4 weeks after maternal vaccination
Two of the mothers are possibly sisters.

Another obscurely recorded and rather confusing case, recorded on January 1, 2006, suggests that there was a fifth

a case of fetal death somehow related to four previous cases.

VAERS ID Number: 249972 Date of Vaccination: 0000-00-00 Age: Date of Enrollment: 2006-01-03 Gender: Where Vaccinated: Unknown. State: North Carolina Vaccine purchased: Not oral.	Life threat? No Is the patient dead? No Disability? No Recovery? No Call an ambulance or a doctor? Yes Hospitalization? No Current medical condition: Laboratory tests: Previous vaccinations: Other medications: Underlying medical conditions:
Vaccines: 1 Flu Lot: Unknown. Dose: 0 Route of administration: Place:
Date of reaction onset: 0000-00-00 Days after vaccination: Symptoms: Unintentional abortion Severity criteria - other significant medical problems. This case belongs to a group of five women (without detailed identification) Patients all received Fluzone SV 2005-2005 USP vaccine on unspecified dates. Vaccination was carried out in local government clinics, doses from different series. No information about series numbers was provided. At an unspecified time after vaccination, all five women experienced intrauterine fetal death. Two patients...

Note:

The style of filling out the form suggests that the information came from a medical professional
'Case cluster' of five women mentioned
All women received the same type of vaccine from the same manufacturer
All vaccines belong to only three series
Vaccination was carried out in local public clinics
At least four of the five cases entered the VAERS database on the same day.

All these facts seemed to mean nothing and did not surprise either the “local public clinics” of North Carolina or the VAERS registration service, where the messages were received.

One can imagine the turmoil that would have erupted if North Carolina's public health sector had simultaneously reported five cases of measles or hepatitis A. Sirens blared and CDC investigators landed with thousands of doses of vaccine (or immunoglobulin) immediately flown in. 24/7 news coverage, and in the case of hepatitis A, the local fast food joint being closed for a week to be thoroughly disinfected by people in bio-suits.

However, when five deaths of viable fetuses occurred simultaneously, nothing was done and almost nothing was said.

Thanks to Red Flags, the Advisory Committee on Immunization Practices is now aware of what happened.

It is possible that the above cases were included in the database only because they were a “group” and the women received the vaccine at “local government clinics.” It is equally possible that there were other similar cases that occurred individually and were never recorded. And the huge number of early miscarriages after flu vaccination in pregnant women is almost certainly not being reported.

On December 15, 2005, a 39-year-old Mississippi mother reported case number 249306 to VAERS. She reported that she received a flu shot on November 29, 2005, and on December 9, an ultrasound revealed that there was no fetal heartbeat.

Another case (#231630), reported on December 28, 2004, reports a 31-year-old Minnesota woman who was six weeks pregnant and received a flu shot on October 28 and had a miscarriage a week later.

In our study in the Journal of American Physicians and Surgeons, we also mentioned the real risk of errors in busy clinics when live nasal influenza vaccine is accidentally given to a pregnant woman. This vaccine is absolutely contraindicated at any stage of pregnancy.

Here is the most recent case from VAERS regarding influenza vaccination in pregnant women. It confirms our worst fears.

VAERS ID number: 250421 Date of vaccination: 2005-11-12 Age: Date of registration: 2006-01-13 Gender: F Where vaccination was performed: Dr. State: Texas Vaccine purchased: Dr.	Life threat? No Is the patient dead? No Disability? No Recovery? No Call an ambulance or a doctor? No Hospitalization? No Current medical condition: Laboratory tests: Previous vaccinations: Other medications: not declared Background medical conditions:
Vaccines: 1 Nasal flu Manufacturer: MEDIMMUNE, INC. Lot: Unknown Dose: 0 Route of administration: Place:
Reaction start date: 0000-00-00 Days after vaccination: Symptoms: PREGNANT ILLNESS Felt unwell (malaise). Vaccination during pregnancy. A non-severe case of a woman’s illness was reported to the database by a pharmacist. A possible cause is Flumist. The woman received the flumist nasal vaccine to prevent influenza on November 12, 2005. At the time of vaccination, she was 31 weeks pregnant. After an unspecified time, she fell ill. The duration of symptoms is not reported.

The stilted style and forced language leave no doubt that the incident was recorded by a VAERS receptionist.

It would be logical to expect that he would try to find out further details through the pharmacist who reported the case, either from the doctor or from the patient herself. Obviously, this, unfortunately, did not happen.

This case is not the only one involving a pregnant woman receiving the live flumist vaccine. VAERS case 219257, reported April 19, 2004, describes the same situation. Here, the patient, shortly after vaccination, complained of high fever, headache, runny nose and sore throat.

The conclusion of a review in the Journal of American Physicians and Surgeons states:

Physicians must continue to protect pregnant patients from any adverse events that could affect the fetus.

Introduction

The effectiveness and safety of any drug is assessed in clinical trials. It is during the study that the body’s reaction to the administration of the drug and the resulting effects, both positive and negative, are assessed. Only in clinical trials is it possible to confirm or refute the expected effect (hypothesis) obtained through theoretical research or experiments on animals or small groups of volunteers [1].

The standard for such studies is randomized controlled trials (RCTs). These studies allow the most accurate and reliable determination of the effectiveness and safety of a vaccine and/or drug [2].

RCT - randomized controlled trial.

Randomized - Participants are randomly assigned to an experimental group - where the study drug is used, and a control group - where a placebo is used. The distribution is carried out regardless of the severity of the disease, age or any other characteristics of the subjects.

Controlled - there are two groups - experimental and control - those who are compared and those with whom they are compared.

Blinding - participants and those assessing the outcome (the manifestation of changes in the participants) do not know what specific treatment is being given - whether they are receiving a drug or a placebo, so the influence of subjective opinion is minimized.

Observational studies, the majority of which, and the implementation of which seem less complex and costly than RCTs, can provide valuable information about the effect of vaccines / drugs on the human body, but due to certain limitations - the methodology of conducting, collecting information, the influence of subjective opinion and other factors - they cannot be considered as a standard [1,2]. In addition, data obtained in several observational studies may sometimes be completely inconsistent with the results of RCTs, which are much more reliable.

So, let's start the analysis.

The immunological effectiveness of vaccination of pregnant women against influenza reaches 70–85% and has been routinely carried out in some countries of Europe and America for more than 25 years, while its purpose is to limit the possibility of infection in the event of epidemic contact of a pregnant woman with a virus carrier [1, 2]. In the post-vaccination period, the formation of specific protective immunity of the pregnant woman occurs, followed by transplacental protection of the fetus and newborn.

In 2005 guidelines, the World Health Organization calls on all countries to provide influenza vaccination to all pregnant women during the epidemic season [3–5]. Pregnant women constitute a high-risk group for the unfavorable course of respiratory infections [5, 6].

Physiological changes that occur during pregnancy predispose to the development of serious complications from any respiratory infection. It has been proven that even in women with uncomplicated pregnancies, inflammatory bronchopulmonary diseases increase the risk of preterm birth [7, 8]. Maternal infection with the influenza virus is one of the causes of antenatal death of the fetus and newborn [6, 9]. During the pre-epidemic period of influenza, the frequency of hospitalizations increases and the health indicators of pregnant women decrease [4, 6]. Modern subunit-free and immunoadjuvant vaccines applied to pregnant women show equal safety and a favorable course of the post-vaccination period [8]. In this regard, the purpose of this study was to assess the effect on the gestational process and immunogenicity of the subunit influenza vaccine in pregnant patients.

In accordance with the relevance of the problem and the objectives of the study, a comprehensive clinical and laboratory examination was carried out on 110 pregnant women, divided into two groups: Group I (main) consisted of 58 patients who received influenza vaccine prophylaxis with a subunit trivalent non-adjuvanted vaccine; II (control) included 52 patients who did not receive influenza vaccine prophylaxis.

The age aspect of women in the study groups was comparable. The average age of the examined women in both groups ranged from 18 to 35 years and was 27.8±0.6 (group I) and 24.1±0.3 (group II), respectively (p>0.05). Among the women of the compared groups, we did not identify significant differences in pregnancy parity. Some of the pregnant women examined were young primiparous women - 39 (35.4%). At the same time, 63 (57.3%) women already had 2 or 3 pregnancies in their history, of which in 79 (72%) cases the first pregnancy ended in term birth, in 9.3% (21 patients) in a medical abortion, for 7 women (3.1%) – spontaneous miscarriage in the first trimester.

The number of full-term births in the examined patients was comparable: in group I – 91 (79.8%), in group II – 86 (78.9%; p>0.05). Analysis of the outcomes of anamnestic pregnancies showed that 25 (11.1%) patients had various forms of gestational losses. When comparing this indicator in clinical groups, no differences were found: (Group I - 12 (10.5%), II - 13 (11.9%; p>0.05). Of the anamnestic births, the most common complications of pregnancy were episodes of threat preterm birth (group I - 8 [18.9%] patients and group II - 7 [17.3%]), of which 9 (8.2%) patients had premature birth, with significant differences in these indicators when distributed among subgroups not detected, p>0.05. At the same time, 95.3% of pregnancies were desired and 76.7% were planned.

Extragenital diseases in the examined pregnant clinical groups were identified in 82 (74.5%) cases. According to the data obtained, the main part of somatic diseases was determined by: hypochromic anemia (group I - 51.7 and II - 57.7%), chronic urogenital infection (group I - 53.4 and II - 42.3%). Frequent acute respiratory viral infections - in 8 (13.7%) and 9 (17.3%), chronic bronchitis - in 7 (12.7%) and 8 (15.4%) of both groups, respectively, chronic pyelonephritis - in 6 (10.3%) in the first group, in the second this nosology was not observed. In women of both groups, signs of vegetative dystonia syndrome, allergic reactivity and euthyroid enlargement of the thyroid gland were present in equal proportions. It should be noted that in more than 20% of cases, the studied patients were diagnosed with lipid metabolism disorders of varying degrees.

A third of 35 (31.8%) patients were diagnosed with mixed forms of sexually transmitted infections. However, analyzing their components, no significant differences were identified in the clinical groups: in clinical group I, 10 (17.2%) were diagnosed with ureamycoplasmosis, in combination with chlamydial infection - in 5 (8.6%), these nosological forms in II group - in 8 (15.3%) and 11 (21.1%), respectively [p>0.05]). The prevalence of human papillomavirus in clinical groups also does not differ significantly.

When analyzing the opportunistic microbial landscape of the examined patients, no significant prevalence of associates was revealed, p>0.05. Thus, the groups, according to the survey of infectious status, have a fairly high infectious index. The infection status of the study groups did not differ significantly. The combination of somatic pathology and infectious index places the examined pregnant women at risk for the development of complications of bronchopulmonary diseases, acute respiratory viral infection, and influenza. When analyzing the anamnesis, it was established that the clinical groups were comparable and did not have significant differences in age categories and reproductive status.

The women were vaccinated with a subunit trivalent vaccine, which is widely used by pregnant women to prevent influenza in European countries and the USA. The drug contained antigens of three current influenza strains: A/California/7/2009/H1N1/v, A/H3N2/ (Victoria) and B/Brisbane, epidemic seasons 2010–2011 and 2011–2012. This vaccine does not have an adjuvant and contains 45 mcg of total hemagglutinin. On the day of vaccination, the somatic and obstetric status of pregnant women was assessed as satisfactory. There were no active infections reported over the next 2 weeks. After immunization of women, a clinical assessment of the post-vaccination period was carried out using the “Assessment of Adverse Post-Vaccination Reactions” scale and based on data from the Self-Observation Diary.

During the entire period of time, which reflected possible post-vaccination reactions after administration of the drug, 9 (39.1%) women vaccinated in the second trimester, and 15 (71.4%) in the third trimester of pregnancy did not have any complaints (p<0. 05).

In general, it can be stated that the clinical tolerability of the subunit influenza vaccine by pregnant women is good and local skin symptoms (hyperemia at the injection site) were not persistent, did not cause systemic changes and did not require special drug correction. The duration of the described symptoms did not exceed 1.5–2.5 days. Evaluation of the hemogram in the dynamics of the post-vaccination period revealed some differences in the morphological composition of peripheral blood. Thus, the hemoglobin level in the initial period among pregnant women subject to vaccination with a subunit trivalent vaccine was lower than in the second clinical group (p<0.05). Subsequently, this indicator did not have significant differences.

Despite some fluctuations in the values of erythrocytes and leukocytes, it was not possible to register significant changes in these blood cells in the compared groups of women (p>0.05). An increase in the number of monocytes was observed in the dynamics of the post-vaccination period in pregnant women of the first group (5.66%±0.46 – initial period, 7.40%±1.39 – 30 days after vaccination, p<0.01), which led to significant difference in this indicator for pregnant women of the second clinical group (3.42%±0.43 – after 30 days of observation, p<0.01). Analysis of the ESR value revealed a slight decrease in group I compared to group II both in the initial period (p<0.05) and 7 and 30 days after vaccination (p<0.05). Despite some differences described in the hemogram, all parameters of peripheral capillary blood had acceptable levels of physiological fluctuations and did not reflect pathological changes in the body of women, which became one of the evidence of the absence of pro-inflammatory activity of the vaccine drug used. Studying the characteristics of the biochemical parameters of the blood of the post-vaccination period of pregnant women vaccinated with a subunit vaccine, no significant changes were revealed that characterize the destabilization of metabolic homeostasis. A moderate increase in creatinine levels was recorded in the early post-vaccination period (59.05±65.54 µmol/l – initial level and 65.54±1.72 – after 7 days of control, p<0.05). During the same observation period, an increase in the concentration of aspartate aminotransferase was detected (19.73±1.15 and 25.60±4.15 U/l, respectively, p<0.0c). The level of alkaline phosphatase, which reflected the processes of phosphorus transport and cellular permeability, increased over the course of observation. However, these changes did not depend on the vaccination carried out the day before, but on the timing of pregnancy (61.93±4.51 IU/l - before vaccination, and 86.23±7.84 - 30 days after vaccination; 51.22±2, 80 IU/l – in the second, and 87.25±10.41 – in the third trimester of pregnancy, p<0.01). Similar changes were observed in the control group of pregnant women.

According to the results of a comprehensive assessment of lipid metabolism in the dynamics of the vaccination process, it was revealed that during 30 days of control there is no tendency to change the described parameters. The main differences reflected only the timing of pregnancy. Thus, the level of total cholesterol in the second trimester was 4.59±0.20 mol/l, in the third – 5.27±0.15 (p<0.05); the concentration of serum triglycerides in the second trimester was 1.90±0.13 mol/l, in the third trimester – 2.84±0.12 (p<0.01). The amount of low-density lipoproteins and very low-density lipoproteins in the third trimester of pregnancy exceeded the values obtained in the second trimester (p <0.01). A similar trend was observed in the control group, which apparently reflects the peculiarities of the physiological development of pregnancy. Analysis of data on the serum content of the studied hormones revealed identical patterns of distribution of values in the compared groups, which depended not so much on the vaccination carried out the day before, but on the duration of pregnancy. The content of progesterone and cortisol reflected comparable trends: it increased taking into account the increasing duration of pregnancy within the comparison groups. The most conservative indicator in the dynamics of observation was estradiol, which did not have pronounced fluctuations in values between groups and trimesters of comparison. We did not find any significant intergroup differences in all parameters studied (Fig. 1).

The level of serum immunoglobulins of the main classes (IgA, IgM, IgG) among pregnant women immediately after vaccination and on the 7th day of the post-vaccination period did not have significant differences in dynamics. After 30 days of control, pregnant women who received the influenza vaccine had a higher level of IgA (group I – 2.56±0.27 mg/ml and group II – 1.44±0.35 mg/ml in the third trimester of pregnancy, p <0.05). At the same time, the IgE concentration after 30 days of control in pregnant women vaccinated with the subunit vaccine was lower (47.08±9.68 IU/ml) than in women in the control group (76.31±11.5 IU/ml, p <0.01). In addition, it was noted that in pregnant women of group II during long-term follow-up, the level of this protein differed by trimester of pregnancy (63.96±9.37 IU/ml – II trimester; 88.14±21.10 IU/ml – III, p <0.05).

Changes in the dynamics of the content of IgG subclasses in vaccinated pregnant women were detected. The level of IgG1 and IgG3 isotypes increases from 9.23±0.72 (IgG1) and 0.98±0.06 mg/ml (IgG3) to 13.49±1.10 (IgG1) and 1.26±0.09 mg/ml (IgG3) 30 days after vaccination; p<0.01 and p<0.05, respectively. We did not find any differences between the comparison groups in the studied parameters (Fig. 2).

The picture of the cytokine cascade of patients in the examined clinical groups generally had trends determined by the mechanisms of physiological gestational immunosuppression: increased levels of interleukins (IL) IL-1, IL-10, and the absence of a significant increase in the levels of proinflammatory cytokines in the post-vaccination period. Nevertheless, the influenza subunit vaccine influenced cytokine secretion: a short-term increase in the level of interferon-γ (IFN-γ), most pronounced in pregnant women in the second trimester of gestation, which possibly characterizes the active involvement of Th1-mediated mechanisms in the post-vaccination immune response. Increased production of IL-4 in the early post-vaccination period as a sign of Th2-dependent activation was observed in women vaccinated against influenza in the third trimester of gestation. Indirect confirmation of this trend was the absence of significant changes in the level of IFN-γ in the early and late post-vaccination periods. All trends in immunogram changes in the study groups did not go beyond the acceptable normal ranges and did not cause destabilization of the functioning of the immune system in pregnant patients.

The values of fetoplacental markers in pregnant women vaccinated against influenza allow us to draw the following conclusion: perhaps the main differences in the described parameters relate mainly to gestational age. More pronounced differences were recorded in trophoblastic β-globulin (TBG) levels within the group between the second (85.05±7.16 ng/ml) and third (151.72±25.14 ng/ml) trimesters (p<0.001), as well as in the dynamics of pregnancy between initial values (93.79±11.47 ng/ml) and one month (118.21±13.99 ng/ml) after vaccination (p<0.05). It is also necessary to note a significant decrease in TBG in clinical group II, which did not receive vaccination. When analyzing the concentration of ɑ-fetoprotein (AFP): values in the second trimester (53.41±5.39 IU/ml) were significantly lower than in the third (162.08±22.69 IU/ml, p<0.001); the initial level (85.72±11.19 IU/ml) was lower than the level obtained one month (110.84±13.92 IU/ml) after vaccination (p<0.05). Similar changes can be observed in group II, without significant differences from pregnant women who received the subunit vaccine (Fig. 3).

The values of fetoplacental markers in pregnant women vaccinated against influenza with a subunit vaccine mainly reflect the dynamic dependencies of gestational age. Thus, TBG in women of clinical groups vaccinated in the second trimester of pregnancy was significantly lower than in the third (p<0.05–p<0.001). There was a direct relationship between the increase in the concentration of TBG and AFP (r=0.60; p<0.05) with an increase in the amount of this protein as the duration of pregnancy increased (p<0.001). Chorionic gonadotropin (hCG) values decreased with gestational age and had an inverse correlation (r=-0.50; p<0.01). According to ultrasound fetometry performed at 21–22 weeks, no significant changes in the main parameters were detected. Trends that reflected some differences in fetal development parameters when studying the fetoplacental complex were diagnosed at later stages of pregnancy: 31–33 weeks of gestation - Group I: abdominal circumference (AC) - 301.02±19.34 mm, fetal weight – 2607.7±55.1 grams; Group II: OB – 251.02±19.54 mm, approximate fetal weight – 2107.7±31.0 grams (p<0.05).

Thus, the identified fetometry values reflect a physiological pregnancy corresponding to the gestational stages of fetal development, which is confirmed by the normal content of markers of the state of the fetoplacental complex in the second trimester. Since the pregnancy of patients in clinical group II was more often complicated by a viral infection (vaccination was not performed), these patients were diagnosed with signs of emerging fetoplacental insufficiency. Differences in fetal development parameters were obtained when studying at 31–32 weeks against the background of a significant decrease in TBG in clinical group II of patients who did not receive vaccination.

When assessing the characteristics of the pregnancy of clinical groups, it should be noted that with the established homogeneity of the status and reproductive potential of the clinical groups, some of them were identified, probably associated with a decrease in gestational complications associated with a decrease in the frequency of acute respiratory viral infections, influenza and exacerbations of bronchopulmonary diseases. In control group II, 19 (32.8%) pregnant women had symptoms of ARVI and influenza during observation: fever – in 9 (17.3%); catarrhal manifestations – in 5 (9.6%); exacerbation of chronic bronchitis – in 5 (9.6%). Influenza was noted in 3 (6.8%) patients of group I (p <0.05). Early toxicosis complicated the first trimester of pregnancy in 7 (12.1%) examined patients of clinical group I and 6 (11.5%) control patients (p>0.05).

The threat of miscarriage in the group of women who did not receive influenza vaccination was significantly higher: in clinical group I in the second trimester - 10 (17.2%), in group II - 17 (32.7%, p<0.05); in the third trimester of pregnancy – 9 (15.5%) and 13 (25%) (p<0.05).

The differences in the incidence of chronic fetoplacental insufficiency in patients of clinical groups turned out to be significant: in group I – 8 (13.8%), in group II – 12 (23% (p<0.001). In group II, signs of fetal growth retardation syndrome were significantly more common in combination with chronic intrauterine fetal hypoxia in 8 (15.3%) patients, in group I - only in 4 (8.6%) (p <0.05).

Vaccination against influenza among pregnant women reduces the frequency of acute respiratory viral and exacerbations of chronic bronchopulmonary diseases, which helps reduce the frequency of dysfunction of the fetoplacental complex.

In most cases (group I - 91.4%, group II - 88.5%) in the observation groups, pregnancy ended in physiological birth. At the same time, for some women, pregnancy ended prematurely with the birth of premature babies (group I - 8.6%, group II - 11.0%). In addition, cases of birth of children with neurological pathology of the perinatal period, mainly associated with gestational immaturity (group I - 7.3%, group II - 10.4%, p <0.05), intrauterine infection syndrome (group I - 3 .4%, II – 9.6%, p<0.05), anomalies and malformations (group I – 1.7%, II – 1.9%, p<0.05).

The early neonatal period of children born to mothers vaccinated during pregnancy had comparable developmental criteria. It was found that in children from observation group 8–9 points on the Apgar scale immediately after birth were recorded in 87.9% of cases (in the control group – 76.9%, p<0.05). A score of 6–7 points on the Apgar scale, which increased to 8–9 points by the 5th minute, was found in 12.1% of newborns in the group of vaccinated mothers, which characterizes generally good indicators of functional maturity.

The nature of feeding of children born to patients vaccinated against influenza did not differ significantly from that of babies born in group II. Natural feeding of children of group I during the neonatal period was recorded in 92.9% of cases, with a gradual decrease in the proportion of breastfeeding in infants to 83.3% by the 3rd month and to 69.0% by the 6th month of life. These data are comparable to the indicators obtained in the control group: 88.6% of breastfeeding cases at 3 months and 60.0% at 6 months. Thus, vaccinating women against influenza during pregnancy does not affect the nature of lactation and the duration of breastfeeding.

The physical development of children in the first 6 months of life in the study groups generally had comparable parameters. The values of body weight and length at different periods of examination of children corresponded to the average corridors (25–50–75) of the centile series. The ratio of weight to height of children born in group I (Quetelet index-I) was 65.5±1.72, which approximately corresponded to the values of the same indicator in children of the control group (67.1±1.03, p>0.05 ).

The proportionality of the physical development of children in the first months of life in most cases had average harmonious values: in clinical group I – 48 (82.8%), in clinical group II – 40 (78.9%), p>0.05. Infants with physical development values below average were identified with equal frequency: in clinical group I – 11 (18.0%), in clinical group II – 11 (21.1%), p>0.05. However, there was a tendency towards more positive values of this indicator in the group of newborns born to vaccinated pregnant women. The results obtained characterize the sufficiency of the main criteria for the course of the neonatal period, reflecting the population maturity of physical development, regardless of the influenza vaccination of mothers during pregnancy.

The indicators of neuropsychic development of children in the group with maternal vaccination did not differ significantly from those obtained from infants in the control group. In general, 82.8% of children in the first 6 months of life born to mothers vaccinated against influenza during pregnancy had no changes in neuropsychic development; in newborns from the control group – in 75%, p>0.05.

It was found that children born to women vaccinated against influenza during pregnancy were 1.7 times less likely to suffer from respiratory infections of non-influenza etiology during the first 6 months of life than children from the control group: in clinical group I 14 (24.1%) and in II – 13 (25.0%), p<0.05.

A study of the level of transplacental IgG antibodies in children whose mothers were vaccinated during pregnancy showed that in the neonatal period for different strains of influenza virus the level of seroprotection was 36.8–73.7%, and with vaccination in the third trimester of gestation it was significantly higher. Thus, when using a subunit trivalent vaccine, seroprotection rates against influenza B virus were 63.2–73.7%. The highest levels of geometric mean antibody titers (GMAT) to influenza A/H1N1/v) and B viruses were detected in newborns whose mothers received influenza vaccination in the third trimester (titer >1:40). At the same time, the lowest values of this indicator for influenza A virus strains /H1N1/v and /H3N2/ were registered in children born to mothers of this clinical group, but vaccinated in the second trimester of pregnancy. 3–6 months after birth, children from vaccinated mothers showed a decrease in SGTAb, which reflects the physiological elimination of protective titers of post-vaccination maternal antibodies.

Levels of titers of protective antibodies to influenza viruses among newborns reflected the trend of intense transplacental transmission of post-vaccination antibodies in hyperimmune pregnant women vaccinated in the second and third trimesters of gestation (r=0.68; p=0.05). In newborns of the maternal group who were vaccinated during pregnancy, high (>1:80) and very high (>1:160) titers of protective antibodies to all three influenza viruses were detected only in the vaccination subgroup in the third trimester of gestation. The results obtained indicate the high immunogenicity of this vaccine in mother-child pairs when used in late pregnancy.

At 3 months of life, most children still retain hemagglutinininhibiting antibodies (HiAbs), but antibodies in highly protective values (>1:80) are not detected. The majority of seropositive children have titers from medium (>1:40) to (>1:20) low values. 6 months after birth in children, antibodies to the influenza virus are detected only in small titers of HiAT (>1:20), which makes it possible to assert that the immunological effect of maternal vaccination has ceased; however, vaccination carried out in the third trimester of gestation is more effective in newborns.

Thus, analyzing the intrauterine and early neonatal periods of development of children of a group of women vaccinated during pregnancy with a subunit influenza vaccine, no negative effect on the physiological course of pregnancy was identified. In the group of newborns born to patients vaccinated during pregnancy with a trivalent subunit vaccine, the rates of intrauterine infection and perinatal damage to the central nervous system were significantly lower. The early postnatal period of life of children born to women vaccinated during pregnancy, compared to the control group, does not differ in the rate of physical and neuropsychic development, as well as in the main health indicators of the neonatal period, reducing the incidence of respiratory infections in the neonatal period.

The effectiveness of vaccination is manifested in the formation of complete immune protection of pregnant and newborn children from influenza. In the blood of newborns, as a result of vaccination of their mothers during pregnancy, specific, transplacentally transferred IgG antibodies circulate in protective titers, which are eliminated by 6 months of the child’s life. Post-vaccination immunity against influenza, formed after vaccination during pregnancy, persists in women for more than 6 months of observation.

The immunogenicity of the vaccine used was assessed by the CPMR criteria, which define the main parameters of the drug’s effectiveness. An analysis of the effectiveness of influenza vaccination in pregnant women, regardless of gestational age, showed that the level of seroprotection (>70%) one month after administration to the A/H1N1/v and B viruses met the criteria for high immunogenicity. For influenza A virus /H3N2/, the level of seroprotection reached values (50%) in pregnant women vaccinated in the second trimester of gestation, while the subunit vaccine turned out to be more highly immunogenic with seroprotection (90.5–100%) in immunized patients at a later stage – in the third trimester of pregnancy. Characterizing the dynamics of the increase and elimination of HiAT by the level of antibody titer, it was revealed that when pregnant women were vaccinated in the third trimester, high values of this indicator for influenza A /H1N1/v were established relative to the second trimester, p<0.05. Used during pregnancy, the vaccine is immunologically effective in providing women with long-term, specific protection. When using this drug, the maximum level of seroprotection is formed when used in the third trimester of gestation.

Thus, analysis of the data obtained from a comprehensive assessment of the clinical and laboratory characteristics of pregnant women vaccinated with a subunit trivalent vaccine showed the absence of destabilizing changes in humoral metabolic homeostasis after vaccination. The early and late post-vaccination periods are accompanied by minor local and systemic reactions. Vaccination against influenza among pregnant women forms stable specific immunity, which reduces the incidence of influenza and acute respiratory viral diseases in the mother and newborn[10].

Interesting places in Moscow

Previously, we compiled a detailed guide to flu vaccinations for children and adults; today we will touch on the topic of vaccination for pregnant women. The article below was written by Elena Savinova, author of the telegram channel “About vaccinations without hysterics.”

Questions about whether pregnant women can and should be vaccinated against influenza are asked with enviable regularity. And although only the lazy did not give answers to them on the Russian-language popular medical Internet, they still continue to come. I decided to write a detailed post on this narrow topic. Nothing special - there will be quotes from the WHO position, Russian federal clinical recommendations (hereinafter referred to as RFCR) and scientific databases.

I’ll start with the fact that, as Sergei Butriy said, in any unclear situation, look at the WHO’s position on vaccines, in this case on influenza vaccines. Let's take a look at some of the provisions from this position (all quotes are taken from the WHO position, unless otherwise stated):

But... pregnant women can’t get vaccinated? That's what they told me at the housing complex

This is wrong. This is not at all true: pregnant women are not only allowed to get vaccinated, but they should be vaccinated. Flu vaccination is directly recommended by WHO and here's why:

Pregnant women are at increased risk of developing severe influenza and death, and the infection can also lead to complications such as stillbirth, neonatal death, premature birth, and low birth weight. When infected with the A(H1N1)pdm2009 strain, pregnant women in New York City were 7.2 times more likely to be hospitalized, and the hospitalization rate for severe influenza was 4.3 times higher than among nonpregnant women.

But the antenatal clinic told me!

Forget what they told you there. Even if this does not contribute to adherence to treatment, I will still write: with knowledge of vaccine prevention, everything is bad not only among the population, but even among some doctors. If a doctor in a residential complex says that vaccinations are prohibited for pregnant women, then he simply has not read the WHO documents and Russian recommendations, which leads to a practical conclusion: you should not listen to this doctor on matters of vaccination.

Is this even safe?

Randomized controlled trials (RCTs) in the United States and Bangladesh examining the safety of influenza vaccination during pregnancy did not demonstrate significant adverse reactions or intrauterine, perinatal, or infancy complications in women's offspring.

Is it possible at any time?

Yes:

Pregnant women should be vaccinated with TIV [trivalent inactivated vaccine - my translation] at any stage of pregnancy. This recommendation is based on evidence that people in this group are at significant risk of developing severe disease and evidence that seasonal influenza vaccine is safe to administer during pregnancy and is effective in preventing influenza in women and their infants, among whom the burden of disease is also high.

Is this safe for the child?

This is not only safe, but will also protect the baby in the first six months of his life, when he a) cannot get a flu vaccine due to his age and also b) will not be able to receive antiviral therapy if he suddenly gets sick with the flu. By age, vaccinations are exactly the same as with whooping cough.

Vaccination against influenza during pregnancy will protect both pregnant women and their newborns from infection.
Children younger than 6 months of age are not eligible for currently licensed influenza vaccines and should be protected against infection by vaccinating their mothers during pregnancy and ensuring their contacts are vaccinated to limit transmission of influenza viruses to infants.

RFKR:

Vaccination against influenza in children in the first six months of life is ineffective; To date, the use of antiviral therapy against influenza in children in the first six months of life is not permitted.

And not only am I pregnant, but I also have asthma, obesity, diarrhea and scrofula. I probably shouldn't get vaccinated against the flu?

You need it all the more. WHO position:

The risk of developing severe infection during pregnancy increases with concomitant asthma, diabetes and obesity.

RFKR:

The most important risk factors leading to hospitalization of pregnant women with influenza are: exacerbation of pre-existing bronchial asthma, obesity, diabetes mellitus, late pregnancy.

WHO pleas

For countries considering introducing or expanding seasonal influenza vaccination programmes, WHO recommends that pregnant women be the highest priority group for vaccination.

My commentary and translation into non-medical Russian. Further, the position talks about the following categories: young children, the elderly, the seriously ill, etc. This phrase means the following: WHO begs on its knees: dear health ministries of poor countries, well, if you don’t have the money to vaccinate the entire population, then at least Find a place to vaccinate pregnant women! They need it first!

Statistics from Russian recommendations

An analysis of cases of death from laboratory-confirmed influenza revealed that the most often aggravating circumstances were […] pregnancy - 4.5%, chronic lung diseases - 3.6%. The 1957 influenza A/H2N2/ pandemic killed more than 50% of women at different stages of pregnancy, which accounted for up to 10% of all deaths from this infection during the epidemic season.

Just think about the flu: it can be treated, especially since there are medications with proven effectiveness. They wrote on Meduza!

RFKR:

Influenza vaccination may reduce a pregnant woman's need to take antiviral medications, which are theoretically more dangerous than using an inactivated vaccine.
The use of antiviral therapy and vaccination against influenza in children under six months of age is unacceptable, therefore the lack of an alternative to effective protection against possible infection and severe consequences of the disease in infants makes vaccination of the expectant mother a priority.

Or maybe it’s still better to pass on antibodies to the baby through breast milk?

Antibodies are transferred to the baby primarily through the placenta. It is this mechanism that underlies influenza and whooping cough vaccination programs for pregnant women to protect unborn children. As for infants, firstly, only newborns (that is, children under about a month old) are able to absorb antibodies through the gastrointestinal tract, and even then this is not the main route of transmission of antibodies to infants. The main one is transplacental. Sad but true. It's sad, but it's true. Moreover, it is stated somewhere that human babies, unlike young rodents, ruminants, etc., do not receive antibodies through breast milk.

Second, to pass influenza virus antibodies to your newborn through breast milk, you need to have had the flu in your baby's first month, a virus that causes 3-5 million cases of severe illness and 250,000-500,000 deaths worldwide. It's a funny prospect, isn't it? Finally, if you catch an adenovirus, parainfluenza, or some other virus from the ARVI group, this will not protect the baby from the flu in any way.

What about thimerosal?

RFKR:

In 2009, WHO additionally reported that there was no evidence of a negative effect of thiomersal (a preservative component of some inactivated vaccines) on infants and adults, including pregnant women.

Okay, we persuaded you. Which influenza vaccine can pregnant women be vaccinated with?

Only inactivated vaccine. Live flu vaccines are prohibited for pregnant women. The WHO position mentions only trivalent vaccines approved for use in pregnant women, so with quadrivalent vaccines presented abroad, you should wait for now and opt for the trivalent one.

I live in Kukuevo. When asked about vaccination, the only gynecologist and therapist in Kukuevo had hair on their heads, and they sternly told me: we won’t vaccinate. Where should I run?

Well, what to do: print out the WHO position in Russian and RFKR, mark the necessary places with a marker and leave it for doctors to study.

What about the ones at home? Should they be vaccinated too?

RFKR:

All people who have direct contact with a pregnant woman (especially children in the first 5 years of life) should be vaccinated against influenza. This requirement reduces the risk of epidemiological contact between a pregnant woman and a sick person and increases the reliability of general and specific prevention of influenza in the family.

Who is still contraindicated for influenza vaccination?

People with hypersensitivity to eggs (those who have an anaphylactic reaction) and sulfites should not be vaccinated against influenza. Do not confuse an anaphylactic reaction with other allergic reactions to eggs. Medscape even writes separately that those who have hives on their eggs can get vaccinated against the flu.

Contraindications for vaccination in pregnant women

You should not get a flu shot if the patient:

There is an allergy to chicken eggs or antibiotics.
Individual intolerance to vaccine components.
There was a severe reaction to the previous vaccination.
If the pregnancy is difficult and there is a high risk of losing the baby.

Whether you can get vaccinated in the first trimester of pregnancy or not should be decided individually with your doctor. Most experts are inclined to give a negative answer and advise waiting for an increase in the period. But if an epidemic is already inevitable (or has arrived) and the number of cases is increasing day by day, it will have to be done. Provided that the woman cannot be protected from outside contacts and she is forced to attend public events and places (the same clinic, shops, work).

What are the complications from vaccination?

Modern vaccines are recognized as safe for patients, but complications cannot always be avoided. However, they happen rarely.

Anaphylactic shock. Causes a sharp drop in blood pressure and oxygen starvation in the child. In particularly severe cases, termination of pregnancy may be necessary.
Allergic reaction to components. Rash, redness of the skin, itching at the injection site, fever, and sometimes angioedema.
Allergic reaction in the fetus.

Conclusion

The flu should not be treated lightly, like a common cold. According to statistics, over 2 million people around the globe die each year from both the flu and its accompanying complications. Avoiding being on this sad list is not at all difficult - get vaccinated, offered by medical institutions. It will not harm you or your baby, but will protect you from the virus for a long time.

Especially for beremennost.net – Ksenia Dakhno

Cochrane review

Last on our list is the Cochrane review [18].

What does the review say?

The review (2015) analyzed one RCT - “Vaccination of pregnant women against influenza and protection of their children” (Madhi, 2014) (a brief description and calculations are given above). The study was chosen because it was randomized, had a large number of participants, and most importantly, it compared the influenza vaccine with a placebo rather than the active ingredient.

Conclusion: Scientists concluded that influenza vaccination in pregnant women does not have significant benefits compared to placebo and does not cause serious side effects [18].

Which vaccine should I choose?

There are 2 types of vaccines: live attenuated and inactivated. Both viruses are grown in chicken embryos, so they contain a certain percentage of chicken protein. Inactivated ones are best suited for a pregnant woman because they do not contain live viruses.

"Influvac". Vaccine from the Netherlands. It contains purified antigens of viruses A and B, formaldehyde, sucrose sodium citrate, polysorbate, chlorides, and protein, which cause lasting immunity. However, every year the drug is improved, which is separately indicated in the instructions (depending on what type of flu is expected in the coming year). The effectiveness of the vaccine has been proven in clinical studies and is 90%.
"Begrivak". Intended for parenteral administration to the shoulder area; it cannot be administered intravenously. It has a number of contraindications (individual intolerance and severe allergic reactions after a previous vaccination), but the development of undesirable consequences has not been registered in Russia since 1998. It is not included in the national calendar, so you need to purchase the vaccine yourself. Simultaneous use with vaccinations against hepatitis B, tetanus, diphtheria, whooping cough, measles and rubella is allowed.
"Vaxigrip." The vaccine contains antibodies from each of the three viruses (two types A and one type B) and additional components. The injection is given in the upper shoulder or thigh. Optimal time for vaccination: autumn-winter period, from September to March. There is only one contraindication – individual intolerance to the components.