FDA briefing says Pfizer vaccine safe and effective

The FDA briefing reckons the Pfizer vaccine is safe and effective. (An expected conclusion and the EU will soon follow suit). The trial had around 44,000 participants.

The FDA’s independent vaccine advisory committee meets on Thursday, 10th December to consider emergency use of Pfizer’s coronavirus vaccine.

During the trial, one participant receiving the vaccine had a severe Covid-19 infection while three receiving placebos were severely infected. Four people in the placebo group died during the trial and two died in the vaccine group. None of the deaths are ascribed to the vaccine.

Antibodies are produced within 10 days.

How long immunity may last is not known. The meeting is expected to focus on safety aspects.


Efficacy Summary
In the final efficacy analysis, among participants without evidence of SARS-CoV-2 infection before and during vaccination regimen, vaccine efficacy (VE) for the first primary endpoint against confirmed COVID-19 occurring at least 7 days after Dose 2 was 95.0%, with 8 COVID-19 cases in the BNT162b2 group compared to 162 COVID-19 cases in the placebo group. The 95% credible interval for the VE was 90.3% to 97.6%, indicating that the true VE is at least 90.3% with a 97.5% probability given the available data. For the second primary endpoint, VE against confirmed COVID-19 occurring at least 7 days after Dose 2 in participants with and without evidence of SARS-CoV-2 infection before and during vaccination regimen was 94.6%, with 9 and 169 cases in the BNT162b2 and placebo groups respectively. The 95% credible interval for the VE was 89.9% to 97.3%, indicating that the true VE is at least 89.9% with a 97.5% probability given the available data.

The AstraZeneca/Oxford vaccine and the Moderna vaccines will also soon get approval. Of course the AstraZeneca vaccine costs only about 10% of the cost of the Pfizer vaccine (excluding the storage and logistic costs) and – in the long run – may generate greater revenues if the vaccination becomes a recurring event. My guess is that the costs of the Pfizer vaccine are too high to be sustainable.


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