FDA advisory panel approves Moderna Covid-19 Vaccine.
By Matthew Perrone and Lauran Neergaard | The Associated Press
WASHINGTON » The head of the Food and Drug Administration said Thursday that his agency will move to quickly authorize the second COVID-19 vaccine to fight the pandemic, hours after the shot won the key endorsement of a government advisory panel.
FDA Commissioner Stephen Hahn said in a statement that regulators have communicated their plans to drug-maker Moderna, which co-developed the vaccine with the National Institutes of Health. The announcement came after a panel of FDA advisers, in a 20-0 vote, ruled that the benefits of the vaccine outweighed the risks for those 18 years old and up.
Once FDA’s emergency use authorization is granted, Moderna will begin shipping millions of doses, earmarked for health workers and nursing home residents, to boost the largest vaccination effort in U.S. history.
The campaign kicked off earlier this week with the first vaccine OK’d in the U.S., developed by Pfizer and BioNTech. Moderna’s shot showed similarly strong effectiveness, providing 94% protection against COVID-19 in the company’s ongoing study of 30,000 people.
After eight hours of discussion over technical details of the company’s study and follow-up plans, nearly all panelists backed making the vaccine available to help fight the pandemic. One panel member abstained.
“The evidence that has been studied in great detail on this vaccine highly outweighs any of the issues we’ve seen,” Dr. Hayley Gans of Stanford University Medical Center said.
A second vaccine is urgently needed as coronavirus infections, hospitalizations and deaths climb to new highs ahead of the holidays. The U.S. leads the world in virus totals, with more than 1.6 million confirmed cases and more than 310,000 reported deaths.
Moderna’s vaccine uses the same groundbreaking technology as Pfizer-BioNTech’s shot. Most traditional vaccines use dead or weakened virus, but both of the new vaccines use snippets of COVID-19’s genetic code to train the immune system to detect and fight the virus. Both require two doses; Moderna’s is four weeks apart.
The two new vaccines will hopefully help “break the back of the pandemic,” said Dr. Arnold Monto of the University of Michigan, who chaired the panel.
Thursday’s review came days after reports of apparent allergic reactions to the Pfizer-BioNTech vaccine in two Alaska health workers. One person had a severe reaction, including shortness of breath, the other had less serious side effects, including lightheadedness.
While the two vaccines use the same technology, they’re not identical, cautioned Moderna chief medical officer Dr. Tal Zaks. In particular, some of the lipids, or fats, used to coat the two vaccines are different.
“I would not necessarily assume” that any reactions would be the same, he said.
The FDA found no severe allergic reactions in Moderna’s data, but flagged a slightly higher rate of less serious side effects — rash, hives, itching — among participants who got the vaccine, compared with those receiving a dummy shot.
Moderna is just starting to study its vaccine in children ages 12 to 17. Testing in younger children is expected to start early next year.
After the FDA acts, U.S. officials plan to move out an initial shipment of nearly 6 million Moderna doses. The vaccine needs to be stored at regular freezer temperatures, but not the ultracold required for Pfizer-BioNTech’s shot.
With the addition of Moderna’s vaccine, government officials project that 20 million Americans will be able to get their first shots by the end of December and 30 million more in January.
Hundreds of millions of additional shots will be needed to eventually vaccinate the general public, which isn’t expected until the spring or summer. The government’s Operation Warp Speed program has orders for 200 million doses of Moderna’s vaccine. That’s on top of 100 million doses of the Pfizer-BioNTech vaccine. Officials are negotiating to purchase more doses of that vaccine and there are more vaccines in the pipeline.
Several states say they have been told to expect far fewer doses of the Pfizer-BioNTech COVID-19 vaccine in its second week of distribution, prompting worries about potential delays in shots for health care workers and long-term care residents.
But senior Trump administration officials Thursday downplayed the risk of delays, citing a confusion over semantics, while Pfizer said its production levels have not changed.
In recent days, governors and health leaders in at least a dozen states have said the federal government has told them that next week’s shipment of the Pfizer-BioNTech vaccine will be less than originally projected.
Little explanation was offered, leaving many state officials perplexed.
“This is disruptive and frustrating,” Washington Gov. Jay Inslee, a Democrat, wrote on Twitter Thursday after learning from the Centers for Disease Control and Prevention that the state’s allocation would be cut by 40%. “We need accurate, predictable numbers to plan and ensure on-the-ground success.”
California, where an explosion in cases is straining intensive care units to the breaking point, will receive 160,000 fewer vaccine doses than state officials had anticipated next week — a roughly 40% reduction.
California hospitals began vaccinations this week from the first Pfizer shipment of 327,000 doses and had expected even more to arrive next week. Instead, officials have been told to expect about 233,000 doses, said Erin Mellon, a spokeswoman for Gov. Gavin Newsom.
In Washington, D.C., two senior Trump administration officials who spoke on condition of anonymity to discuss internal planning said states will receive their full allocations, but misunderstandings about vaccine supply and changes to the delivery schedule may be creating confusion.
One official said the initial numbers of available doses that were provided to states were projections based on information from the manufacturers, not fixed allocations. Some state officials may have misunderstood that, the official said.
California health authorities reported Thursday a record 379 coronavirus deaths and more than 52,000 new confirmed cases as the crisis over care of the sick deepened.
The staggering new figures mean California has seen more than 1,000 deaths in the last five days and nearly 106,000 confirmed cases in just two days.
The pandemic death toll reached 21,860 in California, which has also seen the most cases in the nation with more than 1.7 million confirmed.
Many of the state’s hospitals are now running out of capacity to treat the severest cases, and the situation is complicating care for non-COVID-19 patients.
“It’s pretty much all COVID,” said Arlene Brion, a respiratory therapist at Fountain Valley Regional Hospital, where she’s assigned six or seven patients rather than the usual one to three. “There’s probably two areas that are clean but we’re all thinking eventually it’s all going to be COVID.”
The massive rise in infections began in October and is being blamed largely on people ignoring safety measures and socializing with others. More recently, health officials said they’ve seen cases stemming from gatherings during Halloween and Thanksgiving and have pleaded with residents to avoid getting together with people from other households over Christmas and New Year’s.
A second COVID-19 vaccine, made by Moderna, moved closer to joining the U.S. fight against the coronavirus Thursday during a final public review of its safety and effectiveness. An advisory panel gave its OK to the drug. The shot from Moderna and the National Institutes of Health is urgently needed as the country continues to record ever higher numbers of new cases. BILL SIKES THE ASSOCIATED PRESS
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