Pfizer/BioN Tech COVID-19 Vaccine Concerns

1. Vaccine Safety:

A. No Long-Term Data:We do not have safety data for this vaccine beyond the two months of phase 3 data that has been released. There is a legitimate concern that if too many people cross over from the placebo group to the vaccine group, there will never be enough data to establish long term safety and efficacy data.

B. No Data from Important Groups:According to Pfizer’s FDA Briefing Document: “There are currently insufficient data to make conclusions about the safety of the vaccine in subpopulations such as children less than 16 years of age, pregnant and lactating individuals, and immunocompromised individuals.”

C. Limited Data from COVID’s Most Vulnerable: Only 4.3% of the trial 3 population was over 75 years old and there were zero participant over 80 years old. One CDC scientist, Dr. Helen Talbot of Vanderbilt University, voted against allowing long-term care residents to receive the emergency vaccinations explaining, “I have spent my career studying vaccines in older adults. And we have traditionally tried a vaccine in a young healthy population and then hoped it works in our frail older adults, and so we enter this realm of ‘we hope it works, and we hope it’s safe,’ and that concerns me on many levels.”

D. Allergic Reactions: Two British and an Alaskan health care worker with no history of allergies had an “anaphylactoid reaction, which tends to involve a skin rash, breathlessness and sometimes a drop in blood pressure. This is not the same as anaphylaxis which can be fatal.” Sarah Mbaeyi, a medical officer with the CDC recently stated “People that do report those types of anaphylactic reactions to other vaccines or injectables — they can still get the vaccine, but they should be counseled about the unknown risks of developing a severe allergic reaction and balance these risks against the benefit of vaccination.” According to the Stat News, “Severe allergic reactions to vaccines are extremely rare and were also rare during the Pfizer/BioNTech trial, which excluded people with a history of anaphylaxis.”

E. Bells Palsy: According to Pfizer’s FDA Briefing Document: “Among non-serious unsolicited adverse events, there was a numerical imbalance of four cases of Bell’s palsy in the vaccine group compared with no cases in the placebo group, though the four cases in the vaccine group do not represent a frequency above that expected in the general population.”

2. Post Vaccination Transmission:
According to Pfizer’s FDA Briefing Document : “Data are limited to assess the effect of the vaccine against transmission of SARS-CoV-2 from individuals who are infected despite vaccination. Additional evaluations including data from clinical trials and from vaccine use post-authorization will be needed to assess the effect of the vaccine in preventing virus shedding and transmission, in particular in individuals with asymptomatic infection.”

The design of the phase 3 clinical trials is not to determine if the vaccine can prevent transmission or severe COVID and death (see below) as Peter Doshi, associate editor of the British Medical Journal pointed out here and here .

Additionally, according to the briefing document : “Data are limited to assess the effect of the vaccine against asymptomatic infection as measured by detection of the virus and/or detection of antibodies against non-vaccine antigens that would indicate infection rather than an immune response induced by the vaccine. Additional evaluations will be needed to assess the effect of the vaccine in preventing asymptomatic infection, including data from clinical trials and from the vaccine’s use post-authorization.”

3. Severe COVID & Death:

According to Pfizer’s FDA Briefing Document : “COVID-19 disease may have long-term effects on certain organs, and at present it is not possible to assess whether the vaccine will have an impact on specific long-term sequelae of COVID-19 disease in individuals who are infected despite vaccination.“

“Additional evaluations will be needed to assess the effect of the vaccine in preventing long-term effects of COVID-19, including data from clinical trials and from the vaccine’s use postauthorization.”

“A larger number of individuals at high risk of COVID-19 and higher attack rates would be needed to confirm efficacy of the vaccine against mortality.”