Query: pfizer vaccine safety

title: Covid 19: FDA panel votes to approve Pfizer BioNTech vaccine
abstract: The US Food and Drug Administration's (FDA) independent panel of experts voted on 10 December in favour of emergency use authorisation for the Pfizer BioNTech covid 19 vaccine. The FDA is expected to approve the vaccine within days. Distribution to the states would then begin immediately. Full FDA approval will likely follow. The one day hearing of the Vaccines and Related Biological Products Advisory Committee was broadcast live on YouTube, Twitter, and Facebook. Questions were raised about the safety of the vaccine in people who have had severe allergic reactions and carry an epinephrine injection device, after two allergic reactions were reported in the UK following vaccination.1 Paul Offit, a vaccine expert at the Children's Hospital of Philadelphia, said that "tens of millions of Americans" might

title: High anaphylaxis rates following vaccination with the Pfizer BNT162b2 mRNA vaccine against COVID 19 in Japanese healthcare workers: a secondary analysis of initial post approval safety data
abstract: Takanao Hashimoto, PhD* Akihiko Ozaki, MD, PhD, Divya Bhandari, MHS, Toyoaki Sawano, MD, Ranjit Sah, MD and Tetsuya Tanimoto, MD Department of Pharmacy, Sendai City Medical Center, Sendai, Miyagi, Japan, Department of Breast Surgery, Jyoban Hospital of Tokiwa Foundation, Iwaki, Fukushima 972 8322, Japan, Medical Governance Research Institute, Tokyo 108 0074, Japan, Department of Surgery, Jyoban Hospital of Tokiwa Foundation, Iwaki, Fukushima 972 8322, Japan, Tribhuvan University Teaching Hospital, Institute of Medicine, Kathmandu 44600, Nepal and Internal Medicine, Navitas Clinic Kawasaki, Kanagawa 210 0007, Japan

title: The BNT162b2 (BioNTech/Pfizer) vaccine had 95% efficacy against COVID 19 =7 days after the 2nd dose
abstract: SOURCE CITATION Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid 19 vaccine. . 2020;383:2603 15. 33301246.

title: First Month of COVID 19 Vaccine Safety Monitoring United States, December 14, 2020 January 13, 2021
abstract: Two coronavirus disease 2019 (COVID 19) vaccines are currently authorized for use in the United States. The Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the Pfizer BioNTech COVID 19 vaccine on December 11, 2020, and for the Moderna COVID 19 vaccine on December 18, 2020; each is administered as a 2 dose series. The Advisory Committee on Immunization Practices issued interim recommendations for Pfizer BioNTech and Moderna COVID 19 vaccines on December 12, 2020 (1) and December 19, 2020 (2) respectively; initial doses were recommended for health care personnel and long term care facility (LTCF) residents (3) Safety monitoring for these vaccines has been the most intense and comprehensive in U.S. history, using the Vaccine Adverse Event Reporting System (VAERS) a spontaneous reporting system, and v safe, an active surveillance system, during the initial implementation phases of the COVID 19 national vaccination program (4) CDC conducted descriptive analyses of safety data from the first month of vaccination (December 14, 2020 January 13, 2021) During this period, 13,794,904 vaccine doses were administered, and VAERS received and processed+ 6,994 reports of adverse events after vaccination, including 6,354 (90.8% that were classified as nonserious and 640 (9.2% as serious.SS The symptoms most frequently reported to VAERS were headache (22.4% fatigue (16.5% and dizziness (16.5% A total of 113 deaths were reported to VAERS, including 78 (65% among LTCF residents; available information from death certificates, autopsy reports, medical records, and clinical descriptions from VAERS reports and health care providers did not suggest any causal relationship between COVID 19 vaccination and death. Rare cases of anaphylaxis after receipt of both vaccines were reported (4.5 reported cases per million doses administered) Among persons who received Pfizer BioNTech vaccine, reactions reported to the v safe system were more frequent after receipt of the second dose than after the first. The initial postauthorization safety profiles of the two COVID 19 vaccines in current use did not indicate evidence of unexpected serious adverse events. These data provide reassurance and helpful information regarding what health care providers and vaccine recipients might expect after vaccination.

title: ATAGI statement on AstraZeneca vaccine in response to new vaccine safety concerns A statement from the Australian Technical Advisory Group on Immunisation (ATAGI) on the AstraZeneca COVID 19 vaccine in response to new vaccine safety concerns
abstract: ATAGI recommends that the COVID 19 vaccine by Pfizer (Comirnaty) is preferred over COVID 19 Vaccine AstraZeneca in adults aged under 50 years. This recommendation is based on the increasing risk of severe outcomes from COVID 19 in older adults (and hence a higher benefit from vaccination) and a potentially increased risk of thrombosis with thrombocytopenia following AstraZeneca vaccine in those under 50 years.

title: Modeling excess zeroes in an integrated analysis of vaccine safety
abstract: In prophylactic vaccine studies in healthy populations, many subjects do not experience a single adverse event (AE) Thus, the number of AEs observed in such clinical trials may be difficult to model because of an excess of zeroes relative to the parametric distributions assumed. To determine which type of modeling provides a better fit for observed AE data, a variety of models were applied to data from an integrated safety database from clinical trials of the meningococcal vaccine MenB FHbp (Trumenba(r) bivalent rLP2086; Pfizer Inc, Philadelphia, PA) MenB FHbp was the first vaccine approved in the United States to prevent meningococcal serogroup B disease in individuals aged 10 to 25 years. Specifically, this report presents an integrated analysis of AEs from 8 randomized controlled trials that compared MenB FHbp to placebo or active controls. The number of AEs occurring from dose one to 30 days after the last dose was analyzed. Six models were compared: standard Poisson and negative binomial models and their corresponding zero inflation and hurdle models. Models were evaluated for their ability to predict the number of AEs and by goodness of fit statistics. Models based on the Poisson distribution were a poor fit. The zero inflated negative binomial model and negative binomial hurdle model provided the closest fit. These results suggest that zero inflated or hurdle models may provide a better fit to AE data from healthy populations compared with conventional parametric models.

title: Communicating with patients and the public about COVID 19 vaccine safety: recommendations from the Collaboration on Social Science and Immunisation
abstract: On 8 April 2021, the Australian Technical Advisory Group on Immunisation (ATAGI) made the Pfizer Comirnaty (BNT162b2[mRNA] coronavirus disease 2019 (COVID19) vaccine the preferred vaccine for adults aged under 50 years who have not received a first dose of the COVID19 vaccine AstraZeneca (ChAdOx1S).1 This followed an established causal relationship between the AstraZeneca vaccine and a rare clotting condition named "thrombosis with thrombocytopenia syndrome" (TTS).2 This decision has affected the COVID19 vaccine rollout nationally, given Australia's limited vaccine portfolio the AstraZeneca vaccine is the mainstay for Australia's supply with 53.8 million doses secured, mostly through domestic production.3,4 ATAGI's recommendation occurred 7 weeks into a rollout affected by limited global vaccine supply, difficulties in coordination between the Commonwealth and state and territory governments, and intense media attention. With a limited supply of Pfizer vaccine doses available until later in the year, the recommendation imposes a significant delay in the timeframe in which Australians could be protected from COVID19 and an ongoing vulnerability for the coming winter.

title: Immunogenicity of Pfizer BioNTech COVID 19 vaccine in patients with inborn errors of immunity
abstract: In mid December 2020, Israel had started a nationwide mass vaccination campaign against COVID 19. In the first few weeks, medical personnel, elderly citizens and patients with chronic diseases were prioritized. As such, patients with primary and secondary immunodeficiencies were encouraged to receive the vaccine. While the efficacy of RNA based COVID 19 vaccines was demonstrated in the general population, little is known about their efficacy and safety in patients with Inborn Errors of Immunity (IEI)  To evaluate the humoral and cellular immune response to COVID 19 vaccine in a cohort of IEI patients.  26 adult patients were enrolled, and plasma and peripheral blood mononuclear cells were collected two weeks following the second dose of Pfizer BioNTech COVID 19 vaccine. Humoral response was evaluated by testing anti SARS CoV 2 Spike (S) Receptor Binding Domain (RBD) and anti Nuclear (N) antibody titers, and evaluation of neutralizing ability by inhibition of RBD:ACE2 binding. Cellular immune response was evaluated by ELISpot, estimating IL2 and IFNg secretion in response to pooled SARS CoV 2 S or M peptides.  Our cohort included 18 patients with predominantly antibody deficiency, 2 with combined immunodeficiency, 3 with immune dysregulation, and 3 with other genetically defined diagnoses. 22/26 were receiving immunoglobulin replacement therapy. 18/26 developed specific antibody response and 19/26 showed S peptide specific T cell response. None of the patients reported significant adverse events.  Vaccinating IEI patients is safe, and most patients were able to develop vaccine specific antibody response, S protein specific cellular response or both.

title: The Israeli study of Pfizer BNT162b2 vaccine in pregnancy: considering maternal and neonatal benefits.
abstract: Pregnant patients with COVID 19 are more likely to require intensive care and die compared with non infected pregnant women. While the consequences of COVID 19 disease in pregnancy prompted many health care organizations to support vaccination in pregnancy, vaccine effects for mother and infant remained unclear. In this issue of the JCI, Beharier and Mayo et al. explored maternal and neonatal responses to the Pfizer BNT162b2 SARS CoV 2 mRNA vaccine. The authors examined blood samples from women and cord blood of neonates following childbirth. Samples were stratified into three groups: vaccine recipients, unvaccinated participants with past positive SARS CoV 2 test, and unvaccinated without prior infection. Vaccinated mothers and mothers with previous infection generated and transferred protective IgG antibodies across the placenta. This study provides evidence to support the safety and efficacy of COVID 19 vaccination in pregnancy with protection to the neonate against infection, outlining clear vaccine benefits for both maternal and child health.

title: Acute reduction of visual acuity and visual field after Pfizer BioNTech COVID 19 vaccine 2nd dose: a case report
abstract: Long term and rare adverse effects of COVID 19 vaccines are unknown. Hence, it is important to report them to improve the safety profile of the vaccines and enhance their use worldwide. Here, we describes a case of acute visual impairment after Pfizer BioNTech vaccine second dose.