[ad_1]
Pfizer has overcome the next hurdle in the race to get its Covid-19 vaccine approved for emergency use after the US Food and Drug Administration (FDA) released documents that raised no new concerns about its safety. or efficacy.
Pfizer and its German partner BioNTech submitted data to the FDA last month on their coronavirus vaccine based on data showing that the two-dose regimen was 95% effective against Covid-19 and had no major safety concerns.
The vaccine’s efficacy data met their expectations for emergency use authorization, FDA staff said in documents released ahead of a Thursday meeting of experts outside the FDA who will discuss whether to recommend the Pfizer injection for people of 16 years or older.
The agency generally follows the recommendations of its advisory panels, but is not required to do so.
Latest coronavirus stories
The data from the trial showed that the vaccine began to confer some protection on recipients even before they received the second injection. Agency staff noted that more data would be needed to assess the potential of a single dose.
A two-dose vaccine was very effective in preventing confirmed cases of Covid-19 at least seven days after the last dose, FDA staff said.
Experts will discuss whether it was reasonable to believe that the shot may be effective in preventing Covid-19, the briefing documents showed.
The papers were released on the day that people in the UK began receiving the Pfizer / BioNTech vaccine, the world’s first recipients outside of clinical trials.
FDA staff said there is currently insufficient data to draw conclusions about the safety of the vaccine in children under 16 years of age, pregnant women and those whose immune systems are compromised.
There were a total of six deaths in the late-stage trial of Pfizer’s vaccine, with two deaths among patients who received the vaccine and the remainder among those who received a placebo, the documents showed.
All the deaths represent events that occur in the general population at a similar rate, FDA staff said.
The FDA is expected to decide whether to authorize the vaccine in days or weeks.
[ad_2]