The Covid-19 vaccine by Pfizer-BioNTech is one step closer to official approval by the Food and Drug Administration (FDA) in the United States.
On Tuesday, the FDA released documents that confirmed the safety and efficiency of the coronavirus vaccine by the American pharmaceutical company and the German biotech firm.
A report released by the FDA said the two-dose vaccination was highly effective in preventing confirmed cases of Covid-19 at least seven days after the last dose.
"As such, FDA has determined that the sponsor has provided adequate information to ensure the vaccine's quality and consistency for authorisation of the product under an EUA," staff at the FDA said.
The agency said there was currently insufficient data to make conclusions about the safety of the vaccine in those less than 16 years of age, pregnant women and those whose immune systems were compromised.
The findings, posted on the agency’s website on Tuesday, echoed previously disclosed data from the companies that showed the vaccine was 95 per cent effective in preventing symptomatic Covid-19, adding that two months of trial data revealed no significant safety issues.
In their report, FDA staff wrote that analyses “showed similar efficacy point estimates across age groups, genders, racial and ethnic groups, and participants with medical co-morbidities associated with high risk of severe Covid-19.”
Common side effects included injection-site reactions, fatigue and headache.
Pfizer-BioNTech's vaccine has begun to be rolled out in the UK, with the first non-trial immunisations on Tuesday. Bahrain was the second country to approve use of the vaccine.
Approval for its emergency use in the US could be granted shortly after an FDA advisory meeting on Thursday to discuss the vaccine. The hope is that the country will vaccinate 100 million by April.
The US is facing the worst coronavirus outbreak in the world, with close to 200,000 cases confirmed each day and a daily death toll about 2,000. The country has recorded at least 284,000 deaths linked to Covid-19.
