Israel conducting world's first study of anti-COVID vaccine on pregnant women

After officially endorsing the COVID vaccine for pregnant women, Israel will now become the first country to conduct a study of the vaccine on this previously never-tested-before demographic.

Until now, the vaccine had not been recommended for pregnant women neither by the company that makes it nor by the World Health Organization. But after a spike in serious cases in the past few weeks of COVID patients who are pregnant, Israel’s Ministry of Health gave its approval for pregnant women to vaccinate.

Since the decision, hundreds of pregnant women have already taken the shot — and Sheba Hospital in Tel HaShomer has called on these women to participate in its groundbreaking study that will monitor side effects from the vaccine through pregnancy and childbirth. 

A person connected with the research told ALL ISRAEL NEWS that hundreds of women have agreed to participate.

“We are in a unique situation in that we are vaccinating at such a fast pace compared to the rest of the world,” this person told us. “Also it seems we are the only country that is encouraging women who are pregnant to get the vaccine.”

The person also stressed that the study is not offering the shot for the purposes of a trial, simply asking those who have taken it to answer their questions.

This is the first known study of the effects of the new mRNA vaccine on pregnant women. The research will track the side effects of the vaccine during the pregnancy and birth. Participants will be asked to fill out a questionnaire throughout the pregnancy and, for women who are also patients at Sheba, the study will track the development of antibodies in their blood.

In Pfizer’s own clinical trial, it reported that some women who did not know at the time they were pregnant participated in the study, but reported normal pregnancies and births. Proponents of vaccinating pregnant and breastfeeding women say the lack of data is not evidence of harm.

“There is no evidence of harm resulting from vaccination during the entire pregnancy,” the Health Ministry said adding that instead, “in pregnant women who become infected and fall ill with the coronavirus, there is a higher incidence of a severe onset of the disease, than in a similar age population.”

The directive is only a week old, yet hundreds of pregnant women have been vaccinated or have made appointments to do so.

One pregnant woman told ALL ISRAEL NEWS that she decided to take the vaccine because she was concerned with the spread of seasonal illnesses during winter and the risk of contracting COVID while giving birth at the hospital in the coming months. She researched several health and maternal organizations before deciding.

"From what I saw ... they were leaving it up to the individual," she said. "Many of the world health organizations and other maternal organizations and breastfeeding organization were also recommending it. It made me feel better."

Another woman who is pregnant said she is not fearful of contracting COVID any more than other diseases and that she "will not take the vaccine due to the potential long-term side effects that haven't been researched yet."

"I am handling myself quite naturally, generally keeping the basic guidelines, knowing that anything could happen with infectious diseases, and trusting in the Lord for protection," she told us.

The Israeli Health Ministry recommendation is a departure from the World Health Organization that said “due to insufficient data, WHO does not recommend the vaccination of pregnant women at this time.”

Ilana Rachel Daniel, a health and safety researcher and advocate in Jerusalem, said recommending the vaccine for pregnant women "seems an unnecessary and reckless endeavor."

"No long term safety studies have been done. As the BBC noted, Israel is the world’s guinea pigs. Pregnancy is a time of great vulnerability and has historically been regarded with extra caution in both the field of science and medicine," she told ALL ISRAEL NEWS.

In a brief search while gathering information for this article, we could not find any other country that has officially recommended the vaccine for pregnant women. The U.S. Centers for Disease Control and Prevention and Health Canada have recommended pregnant women who want to get the vaccine do so in consultation with their doctor.

The Royal Australian and New Zealand College of Obstetricians and Gynecologists also weighed in saying that due to insufficient data and a low number of cases in Australia, pregnant women should not get the vaccine. And though many doctors across Britain have recommended the vaccine, the government there still has not made it official.

"The vaccines have not yet been tested in pregnancy, so until more information is available, those who are pregnant should not routinely have this vaccine. Non-clinical evidence is required before any clinical studies in pregnancy can start, and before that, it is usual to not recommend routine vaccination during pregnancy," according to GOV.UK.

Israel’s decision to add pregnant women to the list of those eligible for the vaccines comes as the country pursues a breakneck speed of inoculation, outpacing the entire world in per capita doses of the vaccine. More than 30% of Israelis who are eligible to receive the shot have already done so, according to the Ministry of Health — and all this in just one month.

And just Tuesday, Israel announced another world first after the Health Ministry issued a directive to vaccinate high-risk children under the age of 16. This will open the vaccine to virtually every segment of the country's population. The vaccine has not been tested on children 16 and under.

Israel had just extended the vaccination campaign to high school students this week, ages 16 to 18, ahead of exams and subject to parental approval. The vaccine has been tested on children from 17 and up, not 16, marking another break in Israel from conventional recommendations.

Dr. Gili Regev-Yochay, head of the Infectious Disease Epidemiology Unit at Sheba Medical Center, encouraged pregnant women to get vaccinated after several were hospitalized in serious condition with the coronavirus in recent weeks.

“To all pregnant women who are hesitant to go and get the COVID vaccine, I personally truly recommend it,” she said in a video message. “I think getting COVID while you are pregnant is worse than getting a vaccine that does not seem to be endangering pregnant women in any way. We are giving the flu and pertussis vaccine during pregnancy. An mRNA vaccine should not in any way be more dangerous, and the COVID infection definitely is.”

She noted this week in an interview with i24 News that Israel has noticed a decrease in infected health care workers who have been vaccinated.

“We are definitely optimistic,” she said. “The levels of infected among those vaccinated is definitely lower than those who are unvaccinated and we already see this.”

At the same time, her staff has discovered new side effects from the Pfizer vaccine ranging from paraesthesia – a tingling sensation caused by damage to the nerves – to facial nerve paralysis.

“When we noticed this and spoke with [the company], they started to get reports about this,” Rahav told Kan Reshet Bet on Tuesday. “At the beginning, they said that it was just hysterical women, but it doesn’t seem that way, because we’re seeing this with men as well.”