Pfizer vaccine delay: Americans to get shots 4 days after FDA approval

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  • The head of vaccine rollout in the US said Tuesday that Pfizer’s COVID-19 vaccine may take longer to distribute than previously expected once the Food and Drug Administration (FDA) authorizes it.
  • Gustave Perna, the chief operations officer for Operation Warp Speed, said Americans will be vaccinated four days after the shot’s authorization.
  • This contrasts with other federal officials and health experts, who have said rollout of Pfizer’s vaccine could happen within a day or two of aproval.
  • Dr. Moncef Slaoui, the head of the White House’s coronavirus vaccine effort, told CBS News Sunday that the first vaccine shipment will happen the day after the vaccine is approved by the FDA.
  • Visit Business Insider’s homepage for more stories.

The COVID-19 vaccine may take longer than previously expected to distribute across the US once the Food and Drug Administration (FDA) gives it the green light, according to a top US official.

An independent panel of experts is set to meet Thursday to evaluate the efficacy and safety of the shot developed by Pfizer and BioNTech, which studies suggest is 95% effective. They will then advise the FDA on whether to issue an emergency use authorization.

Gustave Perna, the chief operations officer for Operation Warp Speed, the White House’s vaccine effort, said Tuesday he expects shots to be administered within four days of FDA approval. 

“We will start to have shots in arms within 96 hours,” Perna said during an event at the White House. “That’s what I believe with all my heart.”

This marks a delay on the timeline previously mentioned by other officials and health experts, who have said Americans would be vaccinated within 48 hours of authorization.

Dr. Moncef Slaoui, the head of the White House’s coronavirus vaccine effort, said in a CBS News interview Sunday the first vaccine shipment will happen on the day after the vaccine is approved by the FDA.

James Hildreth, an independent member of the FDA advisory committee, told NBC on Saturday that if the FDA approves the shot, Americans could be vaccinated as early as Friday.

“If the vaccine is approved on the 10th or the 11th, the minute it’s approved, the shipments will start,” he said.

Perna did not say specifically why his prediction was different to that of other officials. He called distribution a “herculean task,” but added that that he was confident “that we will be able to execute this vaccine very efficiently but more importantly effectively.” 

Vaccines could be “moving” throughout the US within 24 hours of approval, he said. 

US regulators wrote in documents released Tuesday that Pfizer’s vaccine showed no safety concerns that could threaten an emergency authorization. Those who were vaccinated experienced temporary side effects afterwards, including a headache, fatigue and a sore arm, they said.

The virus has infected more than 15.2 million people and killed more than 286,000 in the US, according to the New York Times COVID-19 tracker.

The UK has already approved the shot. On Wednesday, the UK drugs regulator said two people had experienced allergic reactions, and advised anybody with a history of “significant” allergies to avoid the shot.

Read more: Here’s how a little-known telehealth startup is poised to make a mark by helping the UK roll out the first coronavirus vaccine

President-elect Joe Biden on Tuesday said in a press conference he wants to see “at least” 100 million COVID-19 vaccine shots “into the arms of the American people” in his first 100 days in office.

The government has ordered 100 million doses of Pfizer’s vaccine — enough to vaccinate 50 million people. But the drugmaker may not be able to offer more shots to the country until next June because the Trump administration rejected “multiple” chances to buy more doses, Dr. Scott Gottlieb, former FDA chief, said Tuesday.

Pfizer, a US pharmaceutical giant, applied for an emergency-use authorization on November 20. Since then, the FDA has been analyzing raw data from the drugmakers to check the safety of the vaccine.

The UK was the first Western nation to vaccinate its population on Tuesday, after the country approved it December 2.

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Source: Pfizer vaccine delay: Americans to get shots 4 days after FDA approval

By insider@insider.com (Kate Duffy)

Techylawyer and its authors do not claim to have written this article, we acknowledge the works of the original author

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