Tag: Approval

HEALTH
Moderna to distribute 6 million COVID-19 vaccines as soon as Friday upon FDA emergency approval

U.S. officials said on Monday they are planning to ship just under 6 million doses of Moderna’s COVID-19 vaccine once it receives emergency use authorization from the Food and Drug Administration.



a hand holding an object in his hand: Moderna to distribute 6 million COVID-19 vaccines as soon as Friday upon FDA emergency approval


© UPI Photo
Moderna to distribute 6 million COVID-19 vaccines as soon as Friday upon FDA emergency approval

CNBC reports that McKesson, a medical supply company, will receive doses of the Moderna vaccine for packaging and distributing to 3,285 sites, according to Gen. Gustave Perna who is in charge of logistics for Operation Warp Speed, the White House’s COVID-19 vaccine program. Perna said that UPS and FedEx have been tasked with getting the vaccine doses to their final locations.

CNBC reports that the vaccine could be approved as early as Friday, one week after Pfizer’s coronavirus vaccine was granted emergency use authorization. Similar to Pfizer, Moderna’s vaccine is given in two doses spaced four weeks apart.

Video: FDA to

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HEALTH
ACIP Adds Seal of Approval to First Authorized COVID Vax

The Pfizer/BioNTech COVID-19 vaccine should be offered to adults ages 16 and older under the FDA’s emergency use authorization (EUA), said the CDC Advisory Committee on Immunization Practices (ACIP) in an emergency meeting on Saturday.

In a 11-0-3 vote (with three members recusing themselves due to conflicts of interest), the committee voted for this interim recommendation. They also voted 14-0 to amend the adult and child/adolescent immunization schedule to recommend COVID-19 vaccination under the scope of use for an EUA.

CDC staff noted that insurance carriers will have 15 business days after the vote and adoption until they will be mandated to cover COVID-19 vaccine administration fees. They said the generic language about COVID-19 vaccines, rather than the Pfizer vaccine, is to ensure there is no delay in coverage as additional vaccines are added.

This planned 2-day emergency meeting took place Friday, with a last minute schedule change. The second

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HEALTH
Trump Pushes For Fast Pfizer Approval As Other Vaccines Hit Snags

President Donald Trump on Friday piled pressure on the US drug regulator to quickly approve the Pfizer-BioNTech Covid-19 vaccine as America readied to roll out mass immunizations.

The Washington Post reported that the White House told the Food and Drug Administration (FDA) chief Stephen Hahn to submit his resignation if the agency does not clear the vaccine by the end of the day.

Hahn later disputed the characterization of the call, but the alleged threat came as Trump tweeted that the agency was a “big, old, slow turtle” and told Hahn to get the “dam” vaccines out immediately.

A woman walks past a costume rental store, with Santa Claus outfits outside, on December 10, 2020 in Paris as France is on a second lockdown in a bid to contain the spread of Covid-19 pandemic caused by the novel coronavirus A woman walks past a costume rental store, with Santa Claus outfits outside, on December 10, 2020 in Paris as France is on a second lockdown in a bid to contain the spread of Covid-19 pandemic caused by the novel coronavirus Photo: AFP / JOEL SAGET

An expert committee had already voted

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HEALTH
White House threatens FDA chief’s job over vaccine approval

WASHINGTON — White House chief of staff Mark Meadows on Friday pressed Food and Drug Administration chief Stephen Hahn to grant an emergency use authorization for Pfizer’s coronavirus vaccine by the end of the day or face possible firing, two administration officials said.

The vaccine produced by Pfizer Inc. and its German partner BioNTech won a critical endorsement Thursday from an FDA panel of outside advisers, and signoff from the agency — which was expected this weekend — is the next step needed to get the shots to the public.

The FDA is not required to follow the panel’s guidance, but the devastation caused by the virus makes the vaccine’s authorization almost certain.

Meadows spoke to Hahn by telephone Friday, according to a senior administration official who was familiar with the call but was not authorized to discuss private conversations.

The chief of staff also told Hahn his job was

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HEALTH
NY Gives OK to Pfizer Vaccine Ahead of Final FDA Approval; NYC Opens Command Center on Monday



a person wearing a costume: A health worker injects a person during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida, U.S., on Wednesday, Sept. 9, 2020. Drugmakers racing to produce Covid-19 vaccines pledged to avoid shortcuts on science as they face pressure to rush a shot to market. Photographer: Eva Marie Uzcategui/Bloomberg via Getty Images


© Bloomberg via Getty Images

A health worker injects a person during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida, U.S., on Wednesday, Sept. 9, 2020. Drugmakers racing to produce Covid-19 vaccines pledged to avoid shortcuts on science as they face pressure to rush a shot to market. Photographer: Eva Marie Uzcategui/Bloomberg via Getty Images


What to Know

  • The FDA’s vaccine advisory panel approved Pfizer’s COVID vaccine — one of the final steps before millions of doses of the shot can be delivered across the country
  • New York Gov. Andrew Cuomo said the state will receive its first deliveries of COVID-19 vaccine Sunday or Monday as the pandemic is landing more patients into hospitals across the state
  • New York City is slated to receive an estimated 72,000 doses — the most for any region in the state. Long Island will receive the second highest
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HEALTH
Two Vaccines Hit Snags As Pfizer Nears US Approval

Two vaccine candidates stumbled Friday in the race among researchers to combat Covid-19, a setback for the global immunisation effort even as the Pfizer-BioNTech jab neared approval in the US.

The mixed news on the vaccine front comes as infections accelerated fast in North America and parts of Africa but started to stabilise in Europe and drop in Asia and the Middle East.

Around the world more than 1.58 million lives have been lost to Covid-19 since it emerged in China a year ago, according to an AFP tally from official sources.

A woman walks past a costume rental store, with Santa Claus outfits outside, on December 10, 2020 in Paris as France is on a second lockdown in a bid to contain the spread of Covid-19 pandemic caused by the novel coronavirus A woman walks past a costume rental store, with Santa Claus outfits outside, on December 10, 2020 in Paris as France is on a second lockdown in a bid to contain the spread of Covid-19 pandemic caused by the novel coronavirus Photo: AFP / JOEL SAGET

While the record-fast development of vaccine options has brought hope to the

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