copenlu/druid huggingface dataset:
Claim: “COVID Vaccines Were Never Safe for Pregnant Women, Pfizer’s own data show” (David Bell, 2023-10-05)
Evidence (2021-11-08): Federal vaccine monitoring systems have identified no safety concerns with the COVID-19 vaccines for pregnant people. Preliminary Centers for Disease Control and Prevention data show that miscarriage is not more frequent than expected in vaccinated people. Online posts, however, falsely contend that such data, as reported in a CDC publication, show an 82% miscarriage rate. There is no evidence that the authorized COVID-19 vaccines pose a risk to pregnant people and their fetuses. Although pregnant people were not actively included in the clinical trials conducted prior to authorization, subsequent information about those who became pregnant during the trials and safety surveillance data following the vaccines’ rollouts thus far have indicated the immunizations are safe. [...] The New England Journal of Medicine article from which the faulty percentage is derived reported on the preliminary findings of the government’s two primary vaccine safety monitoring systems — v-safe, a smartphone-based health checker run by the CDC, and the Vaccine Adverse Event Reporting System — for pregnant people who had received the Pfizer/BioNTech or Moderna vaccines. It concluded there were no "obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines," while acknowledging that additional follow-up of pregnant women, especially those vaccinated early in pregnancy, was needed.
Claim: “COVID Vaccines Were Never Safe for Pregnant Women, Pfizer’s own data show” (David Bell, 2023-10-05)
Evidence (2022-03-01): Latest data reinforces the safety of COVID-19 vaccinations in pregnant women [...] The latest analysis shows that women who had received at least one dose of COVID-19 vaccine during their pregnancy and gave birth between April and October 2021 were more likely to give birth without any of the reported adverse outcomes than women who had not been vaccinated in pregnancy (92.9% compared with 91.6%). This difference was more apparent in those aged 30 years and older. [...] The latest data from the UKHSA support the findings of our own rigorous and ongoing safety monitoring of the COVID-19 vaccines in pregnancy – that these vaccines are safe and that there is no increased risk of pregnancy complications. There is no evidence to suggest that COVID-19 vaccines affect fertility and the vaccines can be taken at any time in pregnancy.
Claim: “COVID Vaccines Were Never Safe for Pregnant Women, Pfizer’s own data show” (David Bell, 2023-10-05)
Evidence (2023-07-15): Vaccination, in general, is usually safe during pregnancy, except for live attenuated vaccines9,10. However, the efficacy and safety of COVID-19 vaccination in pregnancy are unclear. Most COVID-19 vaccine trials failed to include pregnant women due to ethical concerns and the generalizability of the resulting data11,12. Animal data regarding the AstraZeneca vaccine’s usage in pregnancy has been reassuring, without any complications seen in comparable doses in mice13. In addition, data received from unintentionally vaccinated pregnant women from the COVID-19 immunization registry has thus far shown very few complications related to vaccine safety14. However, the lack of clinical trials still may make some women hesitant to receive COVID-19 vaccines, and this is an area where additional data is greatly needed15. Therefore, we performed this systematic review and meta-analysis to compare the maternal and neonatal outcomes between vaccinated pregnant and unvaccinated pregnant women, as well as to determine the antibody titers patterns of COVID-19 antibodies in both maternal and umbilical cord samples, and to determine the efficacy of vaccinations against COVID-19 administered during pregnancy to prevent COVID-19 infection.
Claim: “COVID Vaccines Were Never Safe for Pregnant Women, Pfizer’s own data show” (David Bell, 2023-10-05)
Evidence (2021-06-01): Studies Confirm COVID-19 mRNA Vaccines Safe, Effective for Pregnant Women [...] So, I’m pleased to report results from two new studies showing that the two COVID-19 mRNA vaccines now available in the United States appear to be completely safe for pregnant women. The women had good responses to the vaccines, producing needed levels of neutralizing antibodies and immune cells known as memory T cells, which may offer more lasting protection. The research also indicates that the vaccines might offer protection to infants born to vaccinated mothers. [...] Overall, both studies show that COVID-19 mRNA vaccines are safe and effective in pregnancy, with the potential to benefit both mother and baby. Pregnant women also are more likely than women who aren’t pregnant to become severely ill should they become infected with this devastating coronavirus [3]. While pregnant women are urged to consult with their obstetrician about vaccination, growing evidence suggests that the best way for women during pregnancy or while breastfeeding to protect themselves and their families against COVID-19 is to roll up their sleeves and get either one of the mRNA vaccines now authorized for emergency use.
Claim: “COVID Vaccines Were Never Safe for Pregnant Women, Pfizer’s own data show” (David Bell, 2023-10-05)
Evidence (2022-01-12): COVID vaccines safely protect pregnant people: the data are in [...] Pregnancy and COVID: what the data say COVID vaccines and breastfeeding: what the data say
Claim: “COVID Vaccines Were Never Safe for Pregnant Women, Pfizer’s own data show” (David Bell, 2023-10-05)
Evidence (2021-03-03): But the data that speak most clearly to the question of whether the COVID-19 vaccines harm fertility come from the clinical trials themselves4,5,6. Developmental and reproductive toxicity studies show that the vaccines do not prevent female rodents becoming pregnant or harm the pups if given during pregnancy. We also have an idea of how the vaccines affect pregnancy in humans from the volunteers who became pregnant during the clinical trials. Pregnant people were excluded from the trials and participants were asked to avoid becoming pregnant, but, nonetheless, 57 pregnancies occurred across the trials of the three vaccines that have so far been approved in the UK. The outcomes of these pregnancies, so far as they have progressed, are summarized in Table 1. There was no significant difference in the rate of accidental pregnancies in the vaccinated groups compared with the control groups, which indicates that the vaccines do not prevent pregnancy in humans. Similarly, the miscarriage rates are comparable between the groups, indicating no detrimental effect of vaccination on early pregnancy. [...] So, is COVID-19 vaccination safe during pregnancy? The data so far suggest that it is and, given the increased risks associated with COVID-19 in pregnancy, many pregnant people have decided to accept the vaccine. By monitoring the outcomes for these people and their babies, we will soon be able to make evidence-based recommendations on whether the vaccines should be rolled out to pregnant people more widely. In the meantime, those who are planning pregnancies can rest assured that multiple strands of evidence show that vaccination does not harm fertility.
Claim: “COVID Vaccines Were Never Safe for Pregnant Women, Pfizer’s own data show” (David Bell, 2023-10-05)
Evidence (2021-11-25): Covid vaccines safe in pregnancy, data shows The UK's Health Security Agency says its analysis of English data shows Covid vaccines are safe in pregnancy, reinforcing international evidence. [...] "Every pregnant woman who has not yet been vaccinated should feel confident to go and get the jab and that this will help to prevent the serious consequences of catching Covid in pregnancy," she said.
Claim: “COVID Vaccines Were Never Safe for Pregnant Women, Pfizer’s own data show” (David Bell, 2023-10-05)
Evidence (2021-08-23): Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product. [...] The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals. [...] Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.
Claim: “COVID Vaccines Were Never Safe for Pregnant Women, Pfizer’s own data show” (David Bell, 2023-10-05)
Evidence (2023-03-10): Again, the scientific data from the large phase 3 trials of the Pfizer-BioNTech and Moderna Covid-19 vaccines demonstrated high protective efficacy when the second dose was the same vaccine as the first dose. These vaccines are not interchangeable and the safety and efficacy of combinations of vaccines have not been evaluated. However, the Centers for Disease Control and Prevention recently stated that, in exceptional situations in which the first-dose vaccine product cannot be determined or is no longer available, any available mRNA Covid-19 vaccine may be administered to complete the mRNA Covid-19 vaccination series. [...] Although the large phase 3 trials of the Pfizer-BioNTech and Moderna Covid-19 vaccines did not include pregnant women, eligible pregnant women may be vaccinated. The two mRNA vaccines are not contraindicated during pregnancy. Pregnant women should consider the risks of Covid-19, which may be more severe in pregnant women, and the uncertain risk of vaccination. More information on the safety and efficacy of Covid-19 vaccines in pregnant women will become available over time.
Claim: “COVID Vaccines Were Never Safe for Pregnant Women, Pfizer’s own data show” (David Bell, 2023-10-05)
Evidence (2021-08-03): Three safe, effective COVID-19 vaccines are available in the United States: Pfizer, Moderna and Johnson & Johnson. All three have been put through rigorous clinical trials to determine their safety and efficacy, and all three have been proven to greatly reduce the chance of contracting COVID-19. These vaccines, in short, are life savers. They are a critical piece of the puzzle to stopping new variants from spreading and ensuring that COVID-19 will no longer be a pandemic that threatens the lives of those in our community and around the world. [...] There is absolutely no data from the clinical trials or any theoretical reason as to why or how the vaccines could cause infertility. Women who participated in the COVID-19 clinical trials were able to conceive after vaccination. "In fact, we know that pregnant women with COVID-19 infections are at a higher risk of having a miscarriage or going into premature labor, which is all the more reason to get vaccinated," says Dr. Cunningham. [...] It is safe to get vaccinated during any stage of pregnancy or while breastfeeding. "If you get vaccinated during your third trimester, you could potentially pass protective COVID-19 antibodies to the baby, but it is safe to get vaccinated during any stage of pregnancy," says Dr. Cunningham. "And evidence has shown that breastfeeding people who have received COVID-19 mRNA vaccines have antibodies in their breastmilk, which could help protect their babies from COVID-19."
Claim: “COVID Vaccines Were Never Safe for Pregnant Women, Pfizer’s own data show” (David Bell, 2023-10-05)
Evidence (2022-07-01): But a new study of more than 46,000 pregnant women shows that COVID-19 vaccination does not increase the risk of delivering a premature baby or of having a baby born smaller than expected—both of which are linked to higher chances of infant death and disability. The study, which adds to existing evidence that COVID-19 vaccination during pregnancy is safe, was published on Jan. 4, 2022, by the Centers for Disease Control and Prevention (CDC); Heather Lipkind, MD, a Yale Medicine obstetrician-gynecologist and high-risk pregnancy specialist, was its lead author. [...] This latest study examined 46,079 pregnancies that resulted in a live birth. It included 10,064 pregnant women who received one or more doses of a COVID-19 vaccine between Dec. 15, 2020, and July 22, 2021. Most of the women received Pfizer-BioNTech or Moderna vaccines, and the majority were vaccinated during their second or third trimester.
Claim: “COVID Vaccines Were Never Safe for Pregnant Women, Pfizer’s own data show” (David Bell, 2023-10-05)
Evidence (2023-03-08): The MHRA closely monitors the safety of COVID-19 vaccine exposures in pregnancy, including published information as well as Yellow Card reports for COVID-19 vaccines used in pregnancy. These reports have been reviewed by the independent experts of the CHM’s Medicines for Women’s Health Expert Advisory Group (MWHEAG). Pregnant women have the same risk of getting COVID-19 as non-pregnant women, but they may be at an increased risk of becoming severely ill, particularly if they become infected in the third trimester or if they also have underlying medical problems, compared to non-pregnant women. The current advice of the Joint Committee on Vaccination and Immunisation (JCVI) is that the COVID-19 vaccines, including booster doses, should be offered to those who are pregnant as a clinical risk group in the COVID-19 vaccination programme and can be given at any stage in pregnancy. Pregnant women have reported similar suspected reactions to the original vaccines as people who are not pregnant. The COVID-19 vaccines do not contain organisms that can multiply in the body, so they cannot infect an unborn baby in the womb. There is no pattern from Yellow Card reports or published studies [footnote 2] [footnote 3] [footnote 4] [footnote 5] [footnote 6] [footnote 7]) to suggest that any of the original COVID-19 vaccines used in the UK, or any reactions to these vaccines, increase the risk of miscarriage, stillbirths, congenital anomalies or birth complications. The previous summary of COVID-19 Yellow Card reporting provides full details of safety in pregnancy for monovalent vaccines used in the previous primary and initial booster campaign.
Claim: “COVID Vaccines Were Never Safe for Pregnant Women, Pfizer’s own data show” (David Bell, 2023-10-05)
Evidence (2021-12-23): Pregnant or breastfeeding individuals were excluded from COVID-19 vaccine clinical trials. However, analysis of data collected through international COVID-19 immunization registries to date have not revealed any maternal or neonatal safety signals. [...] Evidence suggests that COVID-19 mRNA vaccination during pregnancy results in comparable antibody titres to those generated in non-pregnant women. Maternal IgG humoral response to mRNA COVID-19 vaccines transfers across the placenta to the fetus, leading to a significant and potentially protective antibody titre in the neonatal bloodstream 1 week after the second dose. Infants of people who received the second dose of a primary series or a booster dose during pregnancy had a lower risk of hospitalization with COVID-19 (including Omicron) compared to infants born to individuals who were unvaccinated. [...] Available post-market vaccine safety data from V-safe, Vaccine Safety Datalink (VSD) and Vaccine Adverse Event Reporting System (VAERS) in the US as of September 2022 show that the Moderna Spikevax (25 mcg) and Pfizer-BioNTech Comirnaty (3 mcg) mRNA COVID-19 vaccines are well tolerated among children aged 6 months to 5 years. No safety signals (including myocarditis) have been identified after administration of about 1.5 million vaccine doses.
Claim: “COVID Vaccines Were Never Safe for Pregnant Women, Pfizer’s own data show” (David Bell, 2023-10-05)
Evidence (2021-12-01): Postmarketing data with Pfizer-BioNTech COVID-19 Vaccine demonstrate increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following the second dose of the primary series. The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males. The observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html). [...] All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. In a reproductive and developmental toxicity study, 0.06 mL of a vaccine formulation containing the same quantity of nucleoside-modified messenger ribonucleic acid (modRNA) (30 mcg) and other ingredients included in a single human dose of Pfizer-BioNTech COVID-19 Vaccine was administered to female rats by the intramuscular route on 4 occasions: 21 and 14 days prior to mating, and on gestation days 9 and 20. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study.
Claim: “COVID Vaccines Were Never Safe for Pregnant Women, Pfizer’s own data show” (David Bell, 2023-10-05)
Evidence (2021-12-08): The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide: [...] COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. [...] This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (including its potential against the Omicron variant, a potential variant-specific vaccine for Omicron, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.
Claim: “COVID Vaccines Were Never Safe for Pregnant Women, Pfizer’s own data show” (David Bell, 2023-10-05)
Evidence (2024-08-08): - Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, Marquez PL, Olson CK, Liu T, Chang KT, Ellington SR, Burke VK, Smoots AN, Green CJ, Licata C, Zhang BC, Alimchandani M, Mba-Jonas A, Martin SW, Gee JM, Meaney-Delman DM. Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant PersonsN Engl J Med 2021 April 21. DOI: 10.1056/NEJMoa2104983 Epub ahead of print. [...] - Moro PL, Olson CK, Clark E, Marquez P, Strid P, Ellington S, Zhang B, Mba-Jonas A, Alimchandani M, Cragan J, Moore C. Post-authorization surveillance of adverse events following COVID-19 vaccines in pregnant persons in the vaccine adverse event reporting system (VAERS), December 2020 – October 2021. Vaccine. 2022 May 26; 40(24):3389-3394. Epub 2022 Apr 12. [...] - Vazquez-Benitez G, Haapala J, Lipkind HS, DeSilva MB, Zhu J, Daley MF, Getahun D, Klein NP, Vesco KK, Irving SA, Nelson JC, Williams JTB, Hambidge SJ, Donahue J, Fuller CC, Weintraub ES, Olson C, Kharbanda EO. COVID-19 Vaccine Safety Surveillance in Early Pregnancy in the United States: Design Factors Affecting the Association Between Vaccine and Spontaneous Abortion. American Journal of Epidemiology. 2023 Mar 16;kwad059. Online ahead of print.
Claim: “COVID Vaccines Were Never Safe for Pregnant Women, Pfizer’s own data show” (David Bell, 2023-10-05)
Evidence (2023-02-10): MYTH: The COVID vaccines were not rigorously tested, which is why they have only emergency authorization approval and not full Food and Drug Administration approval. (Update: Pfizer’s vaccine received full FDA approval on August 19) [...] Hamer: COVID vaccines have been shown to be very powerful in preventing more severe disease and the need for hospitalization. Breakthroughs occur at a much, much lower rate than in people who are unvaccinated. The breakthroughs have been occurring more frequently with the Delta variant because of the high level of infectiousness (or transmissibility) of the Delta variant and lower protection of current vaccines against this variant. But people having breakthroughs have much more mild infection, more like an upper respiratory infection. The vaccines prevent severe disease and complications and allow people to return to a more normal state. [...] MYTH: The COVID vaccines can affect a woman’s fertility.
Claim: “COVID Vaccines Were Never Safe for Pregnant Women, Pfizer’s own data show” (David Bell, 2023-10-05)
Evidence (2024-09-27): COVID-19 Vaccine and Pregnancy COVID-19 vaccines approved by the Food and Drug Administration (FDA) are safe and recommended for people who are pregnant or lactating, as well as for those who are intending to become pregnant. People who are pregnant or were recently pregnant are at a greater risk for severe COVID-19. Having a severe case of COVID-19 while pregnant is linked to a higher risk of preterm birth and stillbirth and might increase the risk of other pregnancy complications. For these reasons, COVID-19 vaccination is recommended for people who are pregnant, intending to become pregnant or were recently pregnant.
Claim: “COVID Vaccines Were Never Safe for Pregnant Women, Pfizer’s own data show” (David Bell, 2023-10-05)
Evidence (2023-05-10): Safety monitoring and clinical data continue to show that the mRNA COVID-19 vaccines are safe for pregnant women and protect them from pregnancy complications due to COVID-19. No evidence from animal or clinical studies suggests that these vaccines cause or increase fertility problems or negative pregnancy outcomes. [...] On 19 April 2023, the Brownstone Institute published an article claiming that Australian regulatory authority the Therapeutic Goods Administration (TGA) had evidence that the Pfizer-BioNTech COVID-19 vaccine was unsafe during pregnancy before approving it provisionally on 27 August 2021. [...] Pfizer’s approval applications for the COVID-19 vaccines have become a regular subject of misinformation for individuals who misuse and distort the data presented in them to support the narrative that the mRNA COVID-19 vaccine is unsafe. In the case of the Brownstone Institute, the article completely misrepresented the results of the experiments, which don’t support and actually contradict the article’s claim, as we will explain below.