The vaccine’s efficacy data meets its expectations for emergency use authorization, the FDA finds in a new report.
Pfizer passed the next hurdle in the race to have its COVID-19 vaccine approved for emergency use in the United States on Tuesday after the United States Food and Drug Administration (FDA) released documents that failed did not raise any new concerns regarding its safety or effectiveness.
Pfizer and German partner BioNTech submitted data to the FDA last month on their coronavirus vaccine based on data showing the two-dose regimen was 95% effective against COVID-19 and had no major safety concerns.
The vaccine’s efficacy data has met its expectations for emergency use clearance, FDA staff said in a report released ahead of an expert meeting Thursday that will discuss whether to recommend. Pfizer vaccine for people 16 years of age and older.
In the 53-page report, the researchers found that the results “showed similar point estimates of effectiveness for age groups, genders, racial and ethnic groups, and participants with high-risk medical comorbidities. of serious COVID-19 ”.
The report also found that there is currently insufficient data to draw conclusions about the safety of the vaccine in children under 16, pregnant women and those with weakened immune systems.
On Thursday, a panel of independent scientists will screen the FDA’s first pass review before recommending whether the vaccine appears safe and effective enough for millions of Americans. The FDA, which usually follows the committee’s advice, is expected to render a decision within days of the review. If given the green light, the first beneficiaries would be healthcare workers and nursing home residents according to plans established by each state.
“The good news is that this very important part of the process is going as it should and as it does with all other FDA regulatory review processes,” said Dr. Helen Boucher, Chief Infectious Disease Officer at Tufts. Medical Center, in an interview with the Reuters news agency.
The United Kingdom became on December 2 the first country worldwide to approve the use of the Pfizer-BioNTech vaccine.
the first person to be vaccinated under that authorization was Margaret Keenan, 90, in Coventry, England on Tuesday.
Pfizer and its German partner BioNTech previously reported that the injections appear to be 95% effective in preventing mild to severe COVID-19 disease in a large, ongoing study. This is based on the first 170 infections detected. Only eight of the infections involved volunteers who received the real vaccine, while the rest had received a dummy vaccine.
Data from the trial showed that the vaccine began to provide some protection to recipients even before they received the required second vaccine. Agency staff noted that more data would be needed to assess the potential of a single-dose injection.
A two-dose vaccination has been very effective in preventing confirmed cases of COVID-19 at least seven days after the last dose, FDA staff said.
This was measured shortly after study participants received their second dose. The duration of this protection is still unknown. “We are looking at the best data possible,” recently warned Dr Paul Offit of the Children’s Hospital of Philadelphia and an FDA adviser. “People are worried, reasonably, how about six months later?”
The other critical issue: security. Pfizer has not reported any serious side effects. Some recipients have had flu-like reactions – including fever, fatigue or muscle aches – especially after the second dose. This is probably a sign that the immune system is speeding up, able to recognize and fight back if the real virus arises.
There were a total of six deaths in Pfizer’s advanced vaccine trial, with two deaths among patients receiving the vaccine and the remainder among those taking placebo, according to the documents. All of the deaths represent events that occur in the general population at a similar rate, FDA staff said.