Pfizer says shot safe, 91% effective after 6 months; will seek full FDA okay

Pfizer says its COVID-19 — used to inoculate more than half of Israel’s population — is 91% effective in preventing the disease up to six months after receiving the second shot, and poses no serious safety concerns, in updated data for over 12,000 people who took part in its original trials.

The US firm and its German partner BioNTech say the vaccine is 100% effective in fighting the South African variant of the virus, based on a sample of 800 participants.

Pfizer CEO Albert Bourla says that in light of the updated results, it plans to submit a request for full regulatory approval in the US, rather than the current emergency FDA approval.

“These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA,” says Bourla. “The high vaccine efficacy observed through up to six months following a second dose and against the variant prevalent in South Africa provides further confidence in our vaccine’s overall effectiveness.”