“Pregnant women should not get vaccinated.” Is that really the case?

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Image: Penu Kiratzov

By Nadezhda Tsekulov

Nadezhda TsekulovNadezhda Tsekulova is a freelance journalist and communications expert.

   

“Pregnant women should not get vaccinated. Women who are planning a pregnancy should not get vaccinated for at least six months before getting pregnant.”

These are the recommendations of the Expert Council on Obstetrics and Gynecology at the Ministry of Health from 18 Feb to 13 Aug 2021. These quotes are not just excerpts – the entire recommendation consists of three points and four sentences precisely. The document does not contain any details, reference literature, or scientific sources, nor the names of its authors. It has not been updated since it was published on the coronavirus.bg website in February and was available in the “Publications” section until 13 Aug 2021.

Meanwhile, in August, leading health and professional obstetrics and gynecology organizations, such as the American Centers for Disease Control and Prevention (CDC), the International Federation of Gynecology and Obstetrics (FIGO) and the Royal College of Obstetricians and Gynaecologists (RCOB), have updated their recommendations for the vaccination of pregnant women, emphasizing that it is not only safe but recommended for pregnant women to get vaccinated against COVID-19 due to their increased risk of severe complications from the infection.

Following a series of interviews and attempts to arrange interviews on this topic with the members of the Expert Council on Obstetrics and Gynecology, while this article was in the making, the publication with these recommendations on the official website coronavirus.bg was taken down – without any explanation.

How did we get here?

The Expert Council on Obstetrics and Gynecology consists of seven specialists. Prof Asen Nikolov is the coordinator, and Prof Slavcho Tomov, Prof Yavor Kornovski, Prof Ekaterina Uchikova, Prof Ivan Kostov, Dr Rumen Velev, and Dr Georgi Stamenov are the members of the council. At the very beginning of the vaccination campaign, they were tasked with preparing recommendations on the process of vaccination of pregnant women in Bulgaria.

At the beginning of 2021, information on the safety of vaccinating pregnant women was still relatively scarce and the available vaccine options were limited. Although the preclinical data indicated that there would be no adverse effects, the World Health Organization (WHO) took a conservative approach and recommended that pregnant women who are not at high risk of contracting the new coronavirus postpone their vaccination.

Some countries, including Bulgaria, adopted this approach. Even then, prestigious professional organizations, such as the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM), stated that there was no reason for pregnant women to be deprived of protection, and called on vaccine manufacturers and the scientific community to make it their priority to work on collecting more data on this issue. However, the recommendation written and published in mid-February in Bulgaria was formulated more as a ban on vaccination not only for pregnant women, but also for those planning on a pregnancy soon.

Four days after the Ministry of Health published their recommendation against the vaccination of pregnant women and women who have not given birth on their official channels (22 Feb 2021), Nadezhda Women’s Health Hospital in Sofia published a recommendation on its website for its patients to get vaccinated against COVID-19. The director of the hospital, Dr Georgi Stamenov, is also a member of the Expert Council on Obstetrics and Gynecology, which  recommends the exact opposite.

“The majority in the Expert Council at the time was adamant that there was no data on the vaccination of pregnant women,” Dr Stamenov said. “However, we met at the hospital and decided locally that given the available information, there shouldn’t be a problem for the pregnant woman or the foetus. I am firmly in favour of vaccinating pregnant women and I think the Expert Council should reconsider their recommendation because we need to protect our pregnant women.” He added that while pregnant women are more reserved and prefer to isolate themselves and take other types of precautions, many of the women who undertake assisted reproduction procedures at his hospital get vaccinated.

Another expert and member of the Council – Prof Ivan Kostov, also said he recommends that his patients get vaccinated. “Since the beginning of the year, a large amount of data has been collected from the countries that have proactively vaccinated their populations, including pregnant women,” he said. “We already know that messenger RNA (mRNA) vaccines are highly effective for pregnant women, and, on the other hand, COVID-19 can be very dangerous for them. All leading international organizations already recommend that expectant mothers get vaccinated with mRNA vaccines.” 

Dr Rumen Velev shared the opposite opinion. “We need unequivocal data on how many pregnant women have been vaccinated and what complications they have had so that we can confidently recommend vaccination,” he said. According to him, many side factors can affect a pregnancy. “If a pregnant woman gets vaccinated and she gets a complication for another reason, she will inevitably associate this complication with the vaccine and that would create an awkward situation,” Dr Velev said. According to him, more efforts are needed to vaccinate the rest of the population so that collective immunity can protect pregnant women without the need for them to get vaccinated. 

What does “pregnant women should not be vaccinated” actually mean?

The unequivocal nature of the recommendation against the vaccination came as a surprise to some of its authors. According to Dr Rumen Velev, the text that the council members discussed among themselves stated that pregnant women have the right to get vaccinated on their own initiative, but this is not recommended due to the lack of sufficiently definite data. He also confirmed that the vaccination of women who have not given birth and are of childbearing age is highly recommended, regardless of when the pregnancy occurs after the end of the vaccination course. Dr Velev has committed to updating this part of the recommendation.

The coordinator of the Expert Council, Prof Asen Nikolov, explained that he was on leave and could not comment on the case. Also due to leave, Prof Ekaterina Uchikova offered her assistance only after 20 Aug. We could not find Prof Slavcho Tomov and Prof Yavor Kornovski for comment before the completion of this article. 

This series of discussions is not the first attempt at a debate with the members of the Expert Council on the quality and nature of their recommendations concerning vaccination against COVID-19 for pregnant women and women who have not given birth and are of childbearing age. As early as March, an application for access to public information was sent to the Ministry and the Expert Council. The author of the application, Elena Lilkova, provided detailed reasoning, although she is not required to do so:

“The only medical branch whose Expert Council is against COVID-19 vaccinations is the “Obstetrics and Gynecology” branch. What is surprising about these recommendations is not only that they contradict the statements and recommendations of almost all relevant international scientific and medical organizations, but also the imperative tone of prohibition that they contain.” 

Her argument is accompanied by references to ten scientific sources and contains six questions regarding the recommendation not to vaccinate pregnant women and to wait six months between the vaccination and getting pregnant for women who have not given birth.

In response, Prof Asen Nikolov said: “We express the position of the Expert Council that it is highly recommended that all non-pregnant women who meet the conditions should get vaccinated against COVID-19.” When it comes to pregnant women, he said that “should not” must be read as “it is not recommended.” The document concludes that “vaccination against COVID-19 of pregnant women, nursing mothers, and those wishing to become pregnant remains their personal right and responsibility. They should make an informed decision as to whether to get vaccinated or not together with their GPs and obstetricians, and after understanding and considering any potential risks and benefits to their health and the health of the foetus.”

Although this response significantly differs from the brief and imperative formal recommendation, the recommendation remained unchanged for five months.

In addition to putting many women at risk, in this form the recommendation can have legal consequences, says lawyer Maria Sharkova, a medical law specialist. “When the members of the Expert Council give a recommendation based on current scientific data, statistics, and research, they are not responsible for the decision that the individual patient makes on whether to get vaccinated or not because they have fulfilled their commitment to summarize the scientific recommendations in the field,” she said. “However, doing the opposite is much riskier. Common doctors are obliged to comply with these recommendations, whether or not they themselves offer a vaccine, and many women may refuse to get vaccinated based on the statement by the Council of Experts. If as a result an unvaccinated pregnant woman becomes seriously ill or loses her life, there may be legal consequences.” 

Vaccinating pregnant women: the scientific discussions

Israel and the United States were the first countries to start vaccinating pregnant women at the beginning of the mass vaccination campaign. At that time, data from preclinical trials of the two mRNA vaccines, which are the only ones used for pregnant women, did not give reasons for concerns about potential risks. However, no pregnant women have taken part in clinical trials. The regulators in the United States (FDA) and Europe (EMA) have not banned the use of vaccines for pregnant women, but the vaccine’s own product characteristics stated that its data was limited.

That’s how, in early March 2021, while the surveys of manufacturing companies among pregnant women were still gaining momentum, the first results appeared. Small, independent studies by U.S. and Israeli teams found that women immunized during pregnancy develop effective immunity and transmit antibodies to their babies through the placenta, and breastfeeding mothers transmit antibodies to their babies through breast milk. Thus, not only the mothers but also their new-borns are protected from a COVID-19 infection.

The research in this direction has expanded and a large-scale study was published in June in the prestigious New English Medical Journal that included a three-month follow-up of more than 35,000 vaccinated pregnant women aged 16 to 54. The results confirmed the initial optimistic data on the efficacy of vaccines with messenger RNA against COVID-19 and that reported adverse effects during pregnancy were lower than in the general population.

Meanwhile, in April, the National Health Service in England launched a campaign to vaccinate pregnant women. To address the uncertainties and doubts about the impact of immunization against COVID-19 for pregnant women, the UK government supported a specialized study, the conclusions of which, however, are still pending.

At the end of July and the beginning of August 2021, the largest relevant international scientific and medical organizations updated their recommendations. The American College of Obstetricians and Gynecologists changed its previous wording that said there is no reason to delay the vaccination of pregnant women. The updated text stated that the organization recommends the vaccination of pregnant women and that their obstetricians or other health care providers should encourage them to get vaccinated.

The Centers for Disease Control and Prevention in the United States also updated their recommendations, focussing on pregnant women because of data showing a high risk of severe COVID-19 cases from the Delta variant that is currently dominant. The International Federation of Gynecology and Obstetrics issued a positive statement supporting the vaccination of pregnant women, emphasizing that they do not need to delay the potential benefits of vaccination. The Federation noted that no clear guidelines for vaccinating pregnant women have been developed yet.

The WHO still maintains a more conservative position, and in its latest document dated June 2021, the organization recommends the vaccination of pregnant women at high risk of infection and those who have concomitant diseases. The recommendations in Germany and France remain similar. The difference with Bulgaria is that in these two countries, over 55% of the population has completed immunization, which reduces the risk of transmitting the coronavirus to pregnant women compared to the risk in an unvaccinated population.

The vaccination of pregnant women in Bulgaria as of 16 Aug 2021

Despite all said so far, until Friday, 13 Aug 2021, the question of reconsidering the firm position that “pregnant women should not be vaccinated” and “women who are planning to become pregnant should not be vaccinated for at least six months before pregnancy” was not placed before the Expert Council on Obstetrics and Gynecology. Neither the Ministry of Health nor any of the members of the Council requested an update on this recommendation. In the course of preparing this material, Dr Rumen Velev, Dr Georgi Stamenov, and Prof Ivan Kostov committed to initiating such a reconsideration, and the text with the recommendations was removed from the official website without explanation.

The department’s press office diverted specific questions regarding these recommendations and sent the following text with a general message:

“Vaccination in Bulgaria is voluntary. The Ministry of Health has provided free access for all Bulgarian citizens to four types of vaccines approved by the EMA. As the brief description of the products shows, there are no absolute contraindications for their placement. The decision whether or not to vaccinate should be made on a case-by-case basis by a physician after assessing the medical grounds for that.

According to the World Health Organization, women who are about to give birth have a higher risk of severe coronavirus infection. UNICEF, for its part, states that there is no reason to avoid getting pregnant following the vaccination.”

The Chief State Health Inspector Association, Prof Angel Kunchev, did not respond to an invitation to explain.

Prof Ilko Getov, a representative of Bulgaria in the European Medicines Agency, commented that although in the first months he was cautious about the vaccination of pregnant women, in the summer he felt ready to justify a change in his position. “In the United States and Europe, not a single case of a problem with the safety of vaccines for pregnant women has been proven,” he said in August. “EMA’s safety committee has seen no such sign, with thousands of doses of vaccines already provided to pregnant women.” In addition to his observations, he pointed to the large-scale study cited in this text, which covered more than 35,000 pregnant women.

According to Prof Getov, it is not necessary to wait for the EMA to change the brief characteristics of any of the vaccines in order to make a national decision for proactive vaccination of pregnant women against COVID-19. “Currently, the brief characteristics for both mRNA vaccines state that they are approved for use in pregnant women, but the data is limited,” he said. “A change [in the characteristics] can be made only when the marketing authorization holders, in this case, the manufacturing companies, request it.”

Instead of a conclusion

Q&A for pregnant women and women planning a pregnancy – a conversation with Dr Tsvetelina Velikova, an immunologist

  1. Is there an increased risk of miscarriage after a pregnant woman receives a COVID-19 mRNA vaccine?

There were such doubts because of two proteins that have a similar structure. A small portion of the SARS-CoV-2 virus spike protein resembles a portion of another protein in placental development called syncytin-1. It has long been shown that these two proteins have similarities in several amino acid sequences at the level of the primary structure of the protein. But when they fold and acquire a secondary, tertiary, and quaternary structure, they no longer have anything in common. Thus, the theoretical hypothesis that antibodies directed against the spike protein could attack the placenta was rejected, including in animal models, and then confirmed by the clinical data from human administration.

  1. Is there a risk when receiving the vaccine during the first trimester of pregnancy?

The risk, in this case, is if the woman’s temperature rises as a side effect of the vaccine. It is possible to control this risk; it is recommended that the pregnant woman’s temperature be lowered with paracetamol. When used for a short period of time, it does not harm the mother or the foetus.

  1. Is there a risk for foetal development?

To date, there is absolutely no evidence from either preclinical trials or clinical experience that vaccines affect the development of the infant in any way before or after birth. There was a large number of women who became pregnant during the clinical trials – they were followed very closely and no adverse events were found.

  1. And is there a risk of side effects in the long run, in the future life of these babies?

Mothers remain concerned that vaccination may have long-term effects on their children. However, we already know that the vaccine does not actually cross the placenta. In other words, it does not directly affect the baby. Only the mother has an immune response, and when she receives the vaccine during pregnancy, the antibodies cross the placenta and thus they may be found in the foetus or the baby after birth. So vaccinating pregnant women in the second and third trimesters of pregnancy protects both the mother and the baby extremely well.

  1. Are there any concerns regarding the fertility of women of reproductive age?

No, quite the opposite. The best option for women who are planning a pregnancy is to get vaccinated before the pregnancy because it still takes time to build up immunity. This will give them peace of mind during the pregnancy.