While the vaccine requires two doses for full protection, the FDA found the risk of contracting Covid-19 is significantly reduced even after the first dose.
(CN) — A detailed analysis released by the U.S. Food and Drug Administration on Tuesday verifies the safety and efficacy of a Covid-19 vaccine developed by Pfizer, two days before a meeting to recommend the vaccine for emergency use.
The FDA released data on the vaccine trials ahead of an advisory committee meeting scheduled for Thursday when a panel of independent experts will review the report along with analysis from the vaccine’s manufacturers, Pfizer Inc. and German partner company BioNTech SE.
The experts will debate the strength of the data in a public and livestreamed meeting. If the panel enters a recommendation, the FDA is expected to quickly grant emergency authorization for the vaccine.
If cleared for distribution, the vaccination effort will begin with health care workers and nursing home residents. Plans for further distribution will vary according to each state’s determinations.
The analysis released Tuesday concluded that the vaccine “met the prescribed success criteria” in a clinical study with over 38,0000 participants aged 16 years and older.
According to the document, the data suggests “a favorable safety profile, with no specific safety concerns identified” that would prevent a decision to authorize emergency use.
The findings reveal that the vaccine was 95% effective in preventing Covid-19 across age groups, genders, and racial lines, and among people with underlying conditions who are at high risk of contracting the illness.
The vaccine requires two doses for full protection. The analysis found that while it prevented Covid-19 in 95% of participants at least seven days after the second dose, the first dose alone prevented severe bouts of the respiratory disease about 89% of the time.
The most common side-effects to the vaccine were skin reactions at the injection site, fatigue and headaches, muscle pain, chills, joint pain and fever. Few serious side effects were observed in the participants, who have all been tracked for at least two months after receiving their second dose.
A total of 12 vaccine recipients experienced appendicitis and four developed cases of Bell’s palsy, a temporary form of facial paralysis. The document says this is in line with the frequency seen in the general population.
The report notes that the study is not yet complete, and more research is needed to confirm that the vaccine prevents even the most severe cases of Covid-19. More data is also needed to determine whether the vaccine works for people who have previously been infected and to pin down how long the vaccine’s protection lasts.
The United Kingdom became the first country to approve the Pfizer vaccine last week and began distribution Tuesday, offering the vaccine to its oldest citizens. Britain has received 800,000 doses of the vaccine so far, enough to inoculate just 400,000 of its 66.65 million citizens.
Approval of another vaccine developed by Oxford University and AstraZeneca could help bolster the global effort to end the pandemic.
On Tuesday, medical journal Lancet published partial results from tests of the vaccine in the U.K., Brazil, and South Africa suggesting it is safe and approximately 70% effective. If approved, the AstraZeneca vaccine could play a major role in fighting Covid-19 due to its lower cost and more relaxed storage requirements.