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Photo: Jean-Philippe Ksiazek/AFP via Getty Images

Pfizer and BioNTech announced Thursday that their COVID-19 vaccine was 91.3% effective at protecting against symptomatic disease up to six months after the second dose, with no serious safety concerns, according to an updated analysis of clinical trial results.

Why it matters: Real-world and trial data continue to indicate that the vaccine is highly effective, especially against COVID-19 hospitalization and death. The companies said updated trial results showed the vaccine offered 100% protection against severe disease as defined by the CDC, and 95.3% as defined by the FDA.

Details: 927 symptomatic COVID-19 cases were detected among the trial's 46,307 participants — 850 of which came from the placebo group and 77 of which came from the vaccine group.

  • 32 cases of severe disease as defined by the CDC were observed in the placebo group, and none were observed in the vaccine group.
  • Researchers found no serious safety concerns in trial participants up to six months after the second dose, and the side effects were consistent with previously reported results.

What they're saying: “It is an important step to further confirm the strong efficacy and good safety data we have seen so far, especially in a longer-term follow-up,” said BioNTech co-founder and CEO Ugur Sahin.

  • “These data also provide the first clinical results that a vaccine can effectively protect against currently circulating variants, a critical factor to reach herd immunity and end this pandemic for the global population," he added.

What's next: Pfizer CEO Albert Bourla said the amount of data collected from the trial puts the companies in a position to file for full FDA approval, after winning an emergency use authorization in December.

Go deeper

Mar 31, 2021 - Health

COVID-19 was the third-leading cause of death in the U.S. in 2020

Expand chart
Data: CDC; Chart: Axios Visuals

COVID-19 was an underlying cause associated with approximately 345,000 deaths during 2020, making it the third-leading cause of death behind heart disease and cancer, two new CDC reports on preliminary mortality data show.

Why it matters: The estimated death rate increased by nearly 16% from 2019, with mortality highest among older people, men or people from disproportionately affected racial and ethnic minority groups.

Updated 20 hours ago - Politics & Policy

Coronavirus dashboard

Illustration: Aïda Amer/Axios

  1. Vaccines: Key FDA committee takes on the big booster question — Los Angeles County to require vaccination proof at indoor bars — France suspends 3,000 unvaccinated health workers without pay.
  2. Health: Worsening crisis at Rikers Island jail spurs call for action — 1 in 500 Americans has died — Cases are falling, but deaths are rising.
  3. Politics: White House invites call with Nicki Minaj to discuss vaccine — Gottlieb says CDC hampered U.S. response — 26 states have limited state or local officials' public health powers.
  4. Education: Denver looks to students to close Latino vaccination gap — Federal judge temporarily blocks Iowa's ban on mask mandates in schools — Massachusetts activates National Guard to help with school transportation.
  5. Variant tracker: Where different strains are spreading.
Mar 31, 2021 - Health

Baltimore plant ruins 15 million Johnson & Johnson coronavirus vaccines

Vials of Johnson & Johnson's coronavirus vaccine in Oakland, California, on March 26. Photo: Gabrielle Lurie/The San Francisco Chronicle via Getty Images

A Baltimore plant run by Emergent BioSolutions that produces coronavirus vaccines ruined a batch of Johnson & Johnson’s vaccine, according to a statement released by Johnson & Johnson Wednesday.

Why it matters: The plant, which was projected to produce and ship tens of millions of Johnson & Johnson doses next month, must now cease producing the one-dose vaccine while the Food and Drug Administration investigates the error, the New York Times first reported. Axios confirmed the report is accurate.