Pfizer Starts Study on Effect of Vaccine on Asymptomatic Cases

On Thursday, Pfizer began its research on the effect of the coronavirus vaccine on asymptomatic persons, just days before the approval. Apart from testing the vaccine among kids and teens, Pfizer is studying whether its vaccine is effective in asymptomatic COVID-19 cases.

Kathrin Jansen, senior vice president at Pfizer, said that the testing on asymptomatic efficacy cases has begun and results could be completed in early 2021. “Our trial was designed not just to look for symptomatic COVID-19 but also to monitor and explore whether our vaccine is efficacious against asymptomatic infection,” she told an advisory panel to the US Food and Drug Administration, who gave the green flag for the vaccine on Thursday. Jansen also added that, now, trial participants are undergoing serological tests that measure exposure to SARS-CoV-2, the virus that causes COVID-19.

Source: Fierce Pharma

The government advisory panel on Thursday backed the use of Pfizer’s COVID-19 vaccine In a 17-4 vote, claiming that the FDA’s Vaccines and Related Biological Products Advisory Committee concluded that the shot appears safe and effective for emergency use in people 16 and older. With a slight debate on whether the age should be upped from 16, since risks to those age groups are low and there wasn’t much data about them in the vaccine trial, the panel voted yes on the question.

Among the topics discussed at the meeting was the warning from British health officials that individuals with “significant” allergic reactions may not be able to get vaccinated. However, Pfizer reps told the panel that, while they’re aware of the British reports, they haven’t seen any signs of allergic reactions in their trial.

The decision came as COVID-19 cases surge to ever-higher levels across the US, with deaths hitting an all-time, one-day high of more than 3,100 on Wednesday. As far as other candidates are concerned, the FDA next week will review a second vaccine, from Moderna and the National Institutes of Health, which is almost as efficacious as the Pfizer shot. A third and single-shot candidate, from Johnson & Johnson, is working its way through the pipeline with final trials underway, while the candidate from AstraZeneca and Oxford University will have to quite possibly re-administer late-stage trials after a testing glitch.