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U.S. data shows AstraZeneca vaccine effective for all adults

AstraZeneca officials said they will apply for emergency

AstraZeneca officials said they will apply for emergency authorization use in the first half of April, and an FDA advisory committee then will review the request. Credit: TNS/JOEL SAGET

A vaccine produced by AstraZeneca has shown to be 79% effective at preventing symptomatic COVID-19 and 100% effective at preventing severe disease and hospitalization, according to new U.S. clinical trial data released by the pharmaceutical firm on Monday.

Some of those clinical trials took place on Long Island, through NYU Langone’s Vaccination Center, with about 150 participants from Nassau and Suffolk counties.

The two-shot vaccine, which has been used in Europe since January, is still several steps from receiving emergency use authorization by the U.S. Food and Drug Administration. AstraZeneca officials said they will apply for emergency use in the first half of April, and an FDA advisory committee then will review the request.

U.S. researchers said they did not find an increased risk of rare blood clots, which were discovered in some people who took the vaccine in Europe. That led several countries to temporarily suspend use of the vaccine earlier this month.

During a news briefing by the White House COVID-19 Response Team on Monday, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, pointed out that the European Medicines Agency and the U.S. clinical trial did not see an increased risk of blood clots during their reviews of the vaccine.

"The FDA is going to very, very carefully go over all of these data," he said. "You can rest assured that the FDA will put a great deal of scrutiny in every aspect of these data."

Investigators said the vaccine worked across adults of all ages, especially older people, in the U.S. clinical trial of more than 30,000 participants.

"I think this is fantastic," said Dr. Steven Carsons, director of the Vaccine Center at NYU Langone Hospital-Long Island. "It’s a great day for science and for everyone because it looks like we are on our way now to having four effective vaccines against the SARS Co-V-2."

Carsons said the fact that the AstraZeneca vaccine can be stored for up to six months in traditional refrigerators is important.

The Pfizer-BioNTech vaccine must be stored at extremely cold temperatures, -70°C±10°C, for up to 10 days unopened or five days at refrigerated 2° to 8°C conditions. The Moderna vaccine must be stored frozen between -25º to -15ºC or refrigerated between 2° to 8°C for up to 30 days before first use. Both Pfizer and Moderna are two-shot vaccines.

The single-dose Johnson & Johnson vaccine can remain stable for two years at -4°F and a maximum of three months at routine refrigeration temperatures of 36 to 46°F.

"This should greatly aid the distribution efforts," Carsons said. "It will also be fairly easy to produce and manufacture, so this should really help get the supply to where we need it to be in order to combat not only the virus but variants."

Area doctors said the more available vaccines, the better.

"We are still in the situation where demand exceeds supply," said Dr. Jason Golbin, senior vice president and chief quality officer at Rockville Centre-based Catholic Health Services, which operates six hospitals on Long Island. "Hopefully, in the next two to four months, we will be able to say supply meets demand. This vaccine would be another tool in the toolbelt."

The more vaccine that's available, the quicker we could reach herd immunity, said Dr. Mark Jarrett, chief quality officer at New Hyde Park-based Northwell Health, the largest health care system in the state. He said the AstraZeneca vaccine will help the United States reach it, even if it isn't immediately approved here.

"We need to reach herd immunity not just here, but everywhere, because people travel to this region, and people who live here are traveling elsewhere," Jarrett said.

The AstraZeneca vaccine is a large part of the United Nations-backed project COVAX, which is focused on getting the vaccine to poor nations across the globe.

The shots are made with a harmless virus, a cold virus that normally infects chimpanzees. It acts like a Trojan horse to carry the coronavirus spike protein’s genetic material into the body that in turn produces some harmless protein. That primes the immune system to fight if the real virus comes along.

Carsons said the Vaccine Center is waiting to get more information on other potential COVID-19 vaccines and would be interested in being part of future clinical studies.

"We hope to be able to shortly begin additional options for people on Long Island," he said.

With AP

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