FDA panel OKs Pfizer vaccine for COVID-19

A US government advisory panel approved emergency use of Pfizer's coronavirus vaccine Thursday, passing the final decision to vaccinate millions of Americans to the Food and Drug Administration.

The FDA could grant its "emergency use authorization", which is a quicker version of full FDA approval, at any time.

The panel's approval came as the coronavirus outbreak in the US set a record Wednesday: 3,124 deaths from COVID-19, the most ever, breaking a record of 2,885 set last week, according to Johns Hopkins University data.

The 17-4 vote with one abstention by the independent non-governmental experts in vaccine development, infectious diseases and medical statistics came after a daylong public hearing on the safety and efficacy of the vaccine from Pfizer and its German partner BioNTech.

The vote concluded that the vaccine appears safe and effective for emergency use in adults and teenagers age 16 and older.

Some panelists said that the recommendation should be for people 18 years of age and older. Panelists also raised some concerns over side effects and reactions.

The Pfizer vaccine already has been given to people in Bahrain and the UK, where it was approved on Dec 2; Canada approved it on Wednesday.

Authorization of Pfizer's vaccine is expected to be followed soon by one for Moderna's vaccine, which uses similar technology and also has shown promise in clinical trials.

Operation Warp Speed, the Trump administration's multi-billion-dollar program to fast-track vaccine development, pre-ordered 100 million doses of Pfizer's vaccine in July and heavily backed the development and manufacturing of Moderna's vaccine.

The federal government has said an initial shipment of 6.4 million doses will leave warehouses within 24 hours of FDA approval. About half of those doses will be sent across the country, and the other half will be reserved for the initial recipients to receive their second dose about three weeks later.

The US also reported 227,828 new coronavirus cases Wednesday, the second-worst day on record. The number of infections in a week set a record of almost 1.5 million, 145 new cases per minute.

At the current pace, the US death toll from the entire pandemic could reach 300,000 in just a few days, according to the Centers for Disease Control and Prevention.

Newly released data from the Health and Human Services Department show at least 200 hospitals were at full capacity last week. In one third of all US hospitals, more than 90 percent of all ICU beds were occupied, according to the data.

Health officials are predicting all the numbers will go higher as the predicted post-Thanksgiving surge has already led to widespread infections and record-setting hospitalizations and deaths. New infections are coming so quickly that hospitals are running out of beds, prompting stay-at-home orders in some places and mask mandates in 38 states.

Agencies contributed to this story.