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- Pfizer’s coronavirus vaccine showed no safety concerns that could threaten an emergency authorization, regulators with the US Food and Drug Administration wrote in documents released Tuesday.
- Detailed data shows that the Pfizer injection is a highly effective and safe vaccine based on a clinical trial of more than 40,000 participants.
- There were temporary side effects that are generally expected with most vaccines. The most common side effects were injection site pain (84%), fatigue (63%), and headache (55%).
- An expert panel convened by the FDA will meet Thursday to discuss Pfizer’s request for emergency authorization. A decision from the agency could come shortly after in a matter of days.
- For more stories, visit the Business Insider home page.
U.S. vaccine regulators released the most detailed analysis yet of a leading coronavirus vaccine candidate on Tuesday, outlining the safety and side effects seen in a massive clinical trial.
Overall, the findings are positive, and the study suggests that there are no major safety concerns for Pfizer’s vaccine. Most of the immunized volunteers had temporary side effects shortly after being vaccinated. Those side effects included fatigue, headache, and injection site pain.
The U.S. Food and Drug Administration is reviewing the Covid-19 injection for emergency use authorization, and a decision is expected within days. A panel of experts will meet Thursday to review Pfizer’s application and recommend a decision to FDA regulators.
Pfizer and its German biotech partner BioNTech tested their vaccine in a global study that randomized more than 40,000 volunteers to receive two doses of their vaccine or two doses of a placebo injection.
While Pfizer said it had enough data to show that its vaccine was a success in preventing Covid-19, with an effectiveness of around 95%, the company had to wait until November 20 to submit its application and accumulate enough. safety information. The FDA requested at least two months of follow-up data for more than half of the volunteers who received their second dose.
The most common side effects included fatigue and headache.
The results showed that the youngest people, those under 55, had more side effects. These side effects are expected with a vaccine, usually appear within a couple of days after receiving a dose and last only a day or two on average.
In their own summary of the data, the FDA scientists said that “no specific safety concerns were identified that would prevent the issuance of a USA.”
These were the most common side effects after receiving the Pfizer vaccine:
- Injection site pain (84%)
- Fatigue (63%)
- Headache (55%)
- Muscle pain (38%)
- Chills (32%)
- Joint pain (24%)
- Fever (14%)
Scientists from the FDA and from Pfizer and BioNTech have been carefully studying the data, particularly to see if there were any unexpected safety issues. It is encouraging that they found nothing to cause concern, according to informational documents released Tuesday.
FDA regulators noted a “number imbalance” in the cases of Bell’s palsy, a condition that temporarily weakens the facial muscles. There were four cases of Bell’s palsy among the more than 20,000 people who received the Pfizer vaccine, compared to no cases in the placebo group.
But the FDA notes that this frequency of Bell’s palsy cases among those who received the Pfizer vaccine was not higher than would be expected for the general population.
Agency scientists also said the vaccine’s safety profile was “generally similar” across different ages, genders, ethnicities, racial groups, the presence of health conditions, and people with or without evidence of prior coronavirus infections in the time of registration. The only expectation was that younger people tended to have more frequent side effects.
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