FDA

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

by

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

by

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

by

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

by

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’

by

President Donald Trump raged at the FDA for taking so long to approve Pfizer’s COVID vaccine on Friday morning and ordered them to ‘stop playing games and start saving lives’ as Health and Human Services Secretary Alex Azar said official approval may still take ‘a couple of days’.   A panel of 23 independent scientists voted … Read more

FDA panel votes to approve Pfizer’s shot

by

The US Food and Drug Administration (FDA) vaccine advisory panel has voted to give Pfizer’s coronavirus vaccine emergency approval.  It’s the last crucial decision before FDA authorizes the shot to be given to Americans, a historic step toward controlling the COVID-19 pandemic in the U.S., which set another grim record with more than 3,000 deaths … Read more

FDA commissioner suggests Pfizer vaccine may not be approved today

by

The commissioner of the FDA said on Thursday morning that Pfizer’s COVID vaccine may not be approved today and that it may take even longer to give it the green light.  An independent advisory committee is meeting today to discuss the findings of Pfizer’s trial but the deliberations aren’t due to begin until 3.10pm. Even though the … Read more

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

by

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

by

There are fears over how safe Pfizer’s COVID vaccine is after two British healthcare workers who were among the first in the world to receive it on Tuesday went into anaphylactic shock hours later, prompting British authorities to tell anyone with a ‘severe’ allergy to food or medicine not to get it.  The FDA is … Read more