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Gulf Insider
3 days ago
- Health
- Gulf Insider
More Fetal Losses Than Expected After Pfizer COVID-19 Vaccination In Israel: Study
A higher-than-expected number of miscarriages and other forms of fetal loss were associated with COVID-19 vaccinations in Israel, a new study has revealed. Researchers found 13 fetal losses—four more than the nine expected—for every 100 pregnant women who received a COVID-19 vaccine during weeks eight to 13 in pregnancy, according to the study, which was published as a preprint on the medRxiv server. Most people in Israel, including pregnant women, received the Pfizer-BioNTech COVID-19 vaccine. Pfizer did not respond by publication time to a request for comment. The team behind the study includes Retsef Levi, a Massachusetts Institute of Technology researcher who was recently named to the committee that advises the Centers for Disease Control and Prevention on vaccines, and Dr. Tracy Hoeg, who works for the Food and Drug Administration. The researchers analyzed electronic health records from Maccabi Healthcare Services, one of four organizations that provide health care to Israelis. They looked at 226,395 pregnancies that occurred between March 1, 2016, and Feb. 28, 2022. The primary analysis looked at fetal loss for pregnant women after dose one or dose three of a COVID-19 vaccine, with fetal loss including miscarriage, abortion, and stillbirth. The researchers came up with an expected number of fetal losses based on a model that drew from data before the COVID-19 pandemic, then compared the expected number of fetal losses with those that occurred from week eight of pregnancy onward. They identified 13,214 fetal losses after the COVID-19 pandemic started, compared with 12,846 fetal losses in the reference period, finding that women who received a COVID-19 vaccine during weeks eight to 13 in pregnancy experienced a higher-than-expected number of fetal losses. 'If you believe this result … every 100 women that you would vaccinate during weeks eight to 13, you are going to see close to four additional fetal losses,' Levi told The Epoch Times. The researchers cautioned that more information is required to say for sure that the vaccines cause fetal losses. They also noted that when they carried out the same analysis for pregnant women who received a COVID-19 vaccine during weeks 14 to 27, the number of fetal losses was lower than expected. An additional analysis of pregnant women who received an influenza vaccine from March 1, 2018, to Feb. 28, 2019, also found a lower-than-expected number of fetal losses. The researchers said those results could stem from what is known as healthy vaccine bias—the data could be skewed because people who receive vaccines are typically healthier than those who do not. Maccabi Healthcare Services did not return an inquiry by publication time. Dr. Yaakov Segal, head of obstetrics and gynecology medicine at the organization, is one of the paper's co-authors. Israel's Ministry of Health and the American College of Obstetricians and Gynecologists, which encourages pregnant women to receive a COVID-19 vaccine in any trimester, did not respond to requests for comment by publication time. 'Generally, medical advice to pregnant women follows the precautionary principle and is based on sound and careful research,' Josh Guetzkow, researcher with Hebrew University of Jerusalem and another study co-author, told The Epoch Times via email. 'Our study shows just how irresponsible it was for our health authorities to abandon these core principles.' COVID-19 vaccination was recommended for pregnant women in Israel and the United States early in the COVID-19 pandemic, even though the clinical trials for the vaccines excluded pregnant women. Moderna's clinical trial for pregnant women was ultimately terminated, while Pfizer ended its trial early after enrolling just 175 women. The latter found slightly lower COVID-19 incidence among the vaccinated when compared with those who received a placebo. Some observational studies have determined that pregnant women benefit from COVID-19 vaccination. The Centers for Disease Control and Prevention recently narrowed its COVID-19 vaccine recommendations and no longer advises COVID-19 vaccination during pregnancy. The new paper was published as a preprint, without peer review. Levi said the paper had been rejected by two journals, and the authors decided that the implications were too important to continue to not release it to the public. Guetzkow said the researchers are going to keep trying to get the paper published by a journal.
Epoch Times
23-04-2025
- Business
- Epoch Times
Novavax Says Its COVID-19 Vaccine Is on Track for FDA Approval After Delay
A company that makes one of the three COVID-19 vaccines available in the United States said on April 23 that its shot is on track for regulatory approval, after regulators declined to grant approval before a deadline. 'We believe that our Biologics License Application (BLA) is approvable based on conversations with the U.S. Food and Drug Administration (FDA),' Novavax 'We have recently received formal communication from the FDA in the form of an information request for a postmarketing commitment (PMC) to generate additional clinical data. We look forward to engaging with the FDA expeditiously to address the PMC request and move to approval as soon as possible.' The FDA was supposed to decide on Novavax's application for a BLA by April 2, but missed the deadline, the company 'Any delays to the FDA's independent review process for the Novavax are a result of scientific review to ensure safety and efficacy,' an official with the Department of Health and Human Services, the FDA's parent agency, told The Epoch Times on April 3. Health Secretary Robert F. Kennedy Jr. Related Stories 4/11/2025 4/3/2025 The FDA did not respond to a request for comment on Wednesday. Dr. Tracy Hoeg, an assistant to the FDA's commissioner, told a meeting on April 15 that the administration will provide an update on the Novavax vaccine soon. The Centers for Disease Control and Prevention currently Just 23 percent of adults and 13 percent of children have received a COVID-19 vaccine in the 2024–2025 season, which started in the fall, according to The FDA in 2024 granted emergency authorization to an updated version of shots from Novavax, Moderna, and Pfizer. Licensure requires a higher level of safety and effectiveness. The FDA has approved the Moderna and Pfizer vaccines for most Americans, although they are still under emergency authorization for some children. Novavax makes a protein-based shot, providing an alternative to the messenger ribonucleic acid platforms that Moderna and Pfizer use. Novavax told investors in February it was expecting a BLA from U.S. regulators in April. If the company receives approval, Novavax will receive a $175 million payment from Sanofi under a partnership the companies reached to co-develop vaccines. Novavax is also working with Sanofi on a combination COVID-19-influenza vaccine. That shot is being tested in phase 3 clinical trials.
