FDA

Dr Fauci says Moderna’s COVID-19 vaccine could get FDA emergency approval TOMORROW

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Moderna’s coronavirus vaccine could get emergency FDA approval as early as Thursday, Dr Anthony Fauci said Wednesday afternoon.  A panel of expert advisors to the Food and Drug Administration (FDA) will met tomorrow to discuss whether to recommend that the agency authorize the second shot to be given to Americans. ‘Tomorrow, the FDA will hopefully … Read more

FDA approves genetically engineered animals as both food and for medical purposes for the FIRST time

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Genetically engineered pigs have been approved by the US Food and Drug Administration – the first time an intentional genomic alteration has been given clearance for both food and medical use. The pigs, called GalSafe pigs, are without a sugar on their skin that can cause a severe allergic reaction among some people. Without the … Read more

AstraZeneca could ask for FDA approval of its shot by February

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AstraZeneca could ask the FDA to approve its coronavirus vaccine as early as February, Operation Warp Speed chief says AstraZeneca’s U.S. trial has hit several delays, including a pause over a rare spinal cord issue in a participant in the UK  Its trials run in the UK and Brazil found the vaccine was 70% effective … Read more

Moderna will ship nearly 6 million doses of its coronavirus vaccine as soon as it gets FDA approval

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Up to six million people will be vaccinated during the first rollout of Moderna Inc’s coronavirus vaccine in the U.S. During a Department of Health and Human Services (HHS) briefing on Monday, officials said medical supply company McKesson will obtain the jabs, which will be sent to 3,285 locations across the country by FedEx and UPS. … Read more

Alex Azar says the FDA will approve Pfizer vaccine ‘in the next couple of days’

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‘Get the damn vaccines out now!’ Trump rages at ‘slow turtle’ FDA for taking so long to approve Pfizer vaccine and tells them ‘stop playing games and start saving lives’ – as Azar says approval may still take ‘a couple of days’ Trump tweeted on Friday that the FDA was a ‘slow turtle’ taking too … Read more

FDA panel votes to approve Pfizer’s shot

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The US Food and Drug Administration (FDA) vaccine advisory panel has voted to give Pfizer’s coronavirus vaccine emergency approval.   Now, the FDA itself will have to accept the committee’s recommendation and Commissioner Stephen Hahn will have to sign off on the emergency approval.  Officials typically take the recommendations of these expert panels, and the FDA … Read more

FDA commissioner suggests Pfizer vaccine may not be approved today

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Scientists on the FDA’s COVID vaccine advisory committee are finally discussing whether or not to approve it and are questioning how long it will protect people for against the virus and whether or not trial participants who were given a placebo should receive it.    The independent advisory committee is meeting today to discuss the findings of … Read more

Pfizer’s first shipment of its coronavirus vaccine will include 2.9 million doses upon FDA approval

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Nearly three people will be vaccinated during the first rollout of Pfizer-BioNTech’s coronavirus vaccine in the US. During a press briefing of the federal government’s Operation Warp Speed on Wednesday, officials said 636 locations, mostly large health-care systems with enough storage capacity, will be receiving the jabs.   According to chief operating officer Gen Gustave Perna, … Read more

Allergy risk on Pfizer jab ahead of key FDA meeting tomorrow

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There are fears over how safe Pfizer’s vaccine is after two British healthcare workers who were among the first in the world to receive it on Tuesday went into anaphylactic shock within hours of receiving the shot.  The FDA is due to meet tomorrow to discuss green-lighting the vaccine in America. In a preliminary analysis … Read more