The coronavirus vaccine made by US drugmaker Pfizer and German biotech firm BioNTech has “no risk” to prevent it from getting an emergency use authorization (EUA), the US Food and Drug Administration (FDA) said Tuesday.
The FDA report came ahead of Thursday’s public meeting where experts will discuss vaccine’s sufficiency for the EUA.
The agency’s findings showed that there are “no specific safety concerns identified that would preclude issuance of an EUA.”
“The vaccine has been shown to elicit increased local and systemic adverse reactions as compared to those in the placebo arm, usually lasting a few days,” the report said. “The most common solicited adverse reactions were injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%).”
Serious adverse events were “uncommon”.
The analysis also affirmed the vaccine effectiveness of 95%, which was previously stated as a result of the companies’ phase 3 trails, at least seven days after dose two.
The proposed dosing regimen is two doses, 30 microgram each, administered 21 days apart.
The data suggested that dose one may be enough to prevent COVID-19 as it shows 82% efficiency, but the FDA analysis said the trial did not have a single-dose arm to make an “adequate comparison” as most of the participants received a second dose after three weeks.
The emergency use authorization is under consideration “for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.”
Meanwhile, Operation Warp Speed — President Donald Trump’s governmental initiative that aims to begin delivering millions of doses of an effective virus vaccine by the end of 2020 — is set to meet with President-elect Joe Biden’s transition team on Thursday.
“We look forward to, you know, sharing all the information and working together,” Moncef Slaoui, chief scientific adviser of the initiative, told ABC New’s Good Morning America program on Tuesday.
“Our objective has always been outside of politics and making sure we make available these vaccines for the US people, and that’s what we’re doing.”
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