Pfizer and BioNTech will apply for emergency use authorization for their COVID-19 vaccine from the Food and Drug Administration Friday, making it the first coronavirus vaccine to be considered for widespread use.
“Pfizer’s partner BioNTech has announced that tomorrow, they intend to file for emergency use authorization at the FDA,” Health and Human Services Secretary Alex Azar said Thursday.
Pfizer announced on Nov. 9 that its vaccine candidate had an efficacy as high as 95%, putting it at about the same level of effectiveness as the measles vaccine, at around 97%.
Earlier this week, pharmaceutical company Moderna announced that its leading vaccine candidate is nearly 95% effective based on analysis by an independent panel of experts. Moderna said that it would submit the vaccine for emergency use authorization “in the coming weeks.”
“We would expect to see Moderna filing soon also,” Azar said, adding, “we will ship millions of doses of vaccine within 24 hours of FDA approval.”
The Centers for Disease Control and Prevention advised people to stay home for Thanksgiving this year, fearing that family gatherings will be virus superspreader events amid a sharp rise in cases, hospitalizations, and deaths.
“What’s at stake is inadvertently someone is infected in that particular household, in that larger family and then spreads it to others, they become infected, and then they go back to their own community, and then that infection is spread to someone else,” Dr. Henry Walke, the CDC’s COVID-19 incident manager, said Thursday.
While the agency’s latest guidance stresses that “postponing travel and staying home is the best way to protect yourself and others,” it included safety precautions people should take, such as getting a flu shot before the trip, wearing a mask at all times, and bringing extra masks and hand sanitizer.
Gov. Gavin Newsom issued a limited stay-at-home order to combat growing coronavirus cases in California. In counties in the purple reopening tier, gathering and nonessential work will have to stop from 10 p.m. to 5 a.m. The order will go into effect this Saturday and will last for a month. Forty-one counties in the Golden State are now in the purple tier.
The coronavirus vaccine being developed by AstraZeneca and the University of Oxford triggers an immune response in older adults ages 56-70, similar to that in young adults ages 18-55, according to a new study published in the British medical journal Lancet.
The results also show that the vaccine may be better tolerated in older adults, who are at a higher risk of getting seriously ill than younger people. Among those who received both doses of the vaccine, systemic reactions such as fevers and rashes occurred in 88% of those ages 18-55, while occurring only in 77% of those ages 56-69 and 65% of those age 70 and older.
To date, there have been over 11.6 million confirmed coronavirus cases in the United States and 251,970 deaths.
Jobless claims last week rose by 31,000 to 742,000, the Labor Department reported Thursday in a troubling sign for the recovery. Economists had projected 700,000 new claims.
“The pandemic is raging on, and with it, the combined toll on health, lives, and the economy,” said Mark Hamrick, Bankrate.com’s senior economic analyst.
Altogether, roughly 1 million workers filed for benefits last week, when including claims for Pandemic Unemployment Assistance, a new category of eligibility created for workers sidelined by the pandemic, such as gig workers whose work dried up.
Nearly 25% of the 300 sailors on the USS Michael Murphy have tested positive for COVID-19. The Murphy, a guided-missile destroyer in the Navy’s Pacific Fleet, has had to delay its training schedule. While many Navy ships have had virus outbreaks, this is the largest outbreak on a Navy vessel to date. The sailors are quarantining, and none are in the hospital.
The World Health Organization Europe’s Regional Director Hans Kluge emphasized that lockdowns would not be necessary if enough people wore masks. “Lockdowns would not be needed,” Kluge said, if 95% of people wore masks, instead of the current 60%.
The National Institutes of Health director, Dr. Francis Collins, said Thursday that U.S. citizens might not have full access to a coronavirus vaccine until July.
In an AARP conference call, Collins said that front-line workers, nursing homes, and people at high risk would be prioritized for the vaccine in December. However, there will not be enough doses to vaccinate that population fully until February or March.
“By the spring, people who are not in one of those high-risk groups will start to also have the chance to get access — we’ve got to start with the high-risk groups first,” Collins said. “And by the summer, hopefully around July or so maybe our country — assuming everybody is willing to take the vaccine, which is another issue — should be able to get access.”
That is later than when White House Coronavirus Task Force member Dr. Anthony Fauci and U.S. Secretary of Health and Human Services Alex Azar have said it would be available. Fauci has said that most people would have access by late April, while Azar has said March or early April.
Centers for Disease Control and Prevention Director Dr. Robert Redfield argued Thursday that K-12 schools are not a source of new outbreaks and should remain open for in-person classes.
“It’s small family gatherings where people become more comfortable they remove their face mask … But it’s not interschool transmission,” Redfield said at the White House Thursday. “The truth is, for kids K through 12, one of the safest places they can be … is to remain in school.”
School districts across the country have chosen to shut down for in-person classes in recent weeks, including Boston and Philadelphia. New York City, the largest school district in the U.S., shut down in-person classes on Thursday after the city’s weekly average hit the 3% positive test rate threshold.
