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Pfizer seeks FDA approval for covid-19 pill regimen, strikes global manufacturing deal

Pfizer's headquarters in New York. (Stephanie Keith/Bloomberg News)
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Pharmaceutical giant Pfizer requested emergency authorization Tuesday for Paxlovid, a five-day antiviral pill regimen the company found to reduce the risk of hospitalization or death by 89 percent.

The announcement comes as covid-19 cases increase in many parts of the country, raising fears among public health officials that a fifth case surge could hit the nation during the winter. If authorized, the drug could help stave off hospitalizations and deaths that are already overwhelming hospitals in states such as Colorado and Minnesota.

With its promising findings, Pfizer also agreed to a license-sharing deal that would allow its experimental covid-19 drug to be manufactured more widely across the globe, giving more than half of the world’s population access to the treatment, the company said.

Here’s what to know

  • The FDA is expected to grant a request from Pfizer and its partner BioNTech — perhaps as soon as this week — to authorize boosters for their vaccine for everyone 18 and older.
  • A growing number of governors from both political parties are circumventing federal guidance to offer boosters to anyone over 18 in hopes of staving off a spike in cases over the holidays.
  • While southern states have emerged from a late summer and early autumn delta variant-fueled surge, the Mountain West and upper Midwest are now seeing a dramatic uptick in cases.
  • Crowds will return to Times Square to ring in 2022, Mayor Bill de Blasio (D) announced Tuesday, with proof of vaccination required for entry.
  • At least 50 percent of people who survive covid-19 experience health issues for six months or more after their recovery, according to new research.

Coronavirus: What you need to know

Vaccines: The CDC recommends that everyone age 5 and older get an updated covid booster shot designed to target both the original virus and the omicron variant. Here’s some guidance on when you should get the omicron booster and how vaccine efficacy could be affected by your prior infections.

Variants: Instead of a single new Greek letter variant, a group of immune-evading omicron spinoffs are popping up all over the world. Any dominant variant will probably challenge a key line of treatment for people with compromised immune systems — the drugs known as monoclonal antibodies.

Tripledemic: Hospitals are overwhelmed by a combination of respiratory illnesses, staffing shortages and nursing home closures. And experts believe the problem will deteriorate further in coming months. Here’s how to tell the difference between RSV, the flu and covid-19.

Guidance: CDC guidelines have been confusing — if you get covid, here’s how to tell when you’re no longer contagious. We’ve also created a guide to help you decide when to keep wearing face coverings.

Where do things stand? See the latest coronavirus numbers in the U.S. and across the world. In the U.S., pandemic trends have shifted and now White people are more likely to die from covid than Black people.

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