FDA Panel to Decide on Novavax COVID Vaccine

 By By Robert Preidt HealthDay Reporter, HealthDay Reporter



(HEALTHDAY)


TUESDAY, June 7, 2022 (HealthDay News) -- A U.S. Food and Drug Administration vaccine advisory panel will weigh whether to recommend the emergency use of Novavax's COVID-19 vaccine on Tuesday.


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The decision will be based on clinical trial data the company released in January, when it first filed for approval of its vaccine. If the committee votes in favor of authorization, the FDA would have to sign off on Novavax's manufacturing process for the two-dose vaccine.


Novavax was an early beneficiary of the federal government's Operation Warp Speed program. Its vaccine would be the fourth to be approved for adults in the United States.


The vaccine contains nanoparticles composed of proteins from the surface of the coronavirus, making it different from the vaccines developed by Pfizer, Moderna and Johnson & Johnson.


“We remain committed to ensuring that any American who wants a vaccine can get one, including those that prefer a non-mRNA option,” Jorge Silva, a spokesman for the U.S. Department of Health and Human Services, told The New York Times.


The Pfizer and Moderna shots are mRNA vaccines.


Even if the Novavax vaccine is authorized by the FDA, it's not clear how widely it would be used. The Pfizer, Moderna and Johnson & Johnson vaccines have been available for well over a year and there is no shortage of doses in the United States. In fact, 82 million doses of COVID-19 vaccines have gone to waste in this country.


In a number of countries where the Novavax vaccine is already available, uptake has been low, according to the Times.


The Biden administration is working with Novavax to receive “a limited quantity of vaccine” if it gets the green light, Silva said.


More information


Visit the U.S. Food and Drug Administration for more on COVID vaccines.


SOURCE: The New York Times

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WEDNESDAY, June 8, 2022 (HealthDay News) -- Even after vaccination, living with HIV ups the odds for COVID infection, new research shows. Recommended Videos Powered by AnyClip Pfizer’s 3-Dose Vaccine 80% Effective Against Omicron Infection for Youngest Children 1.4K Play Video Pfizer’s 3-Dose Vaccine 80% Effective Against Omicron Infection for Youngest ChildrenNOW PLAYING This Is How a COVID-19 Infection Could Damage Your Brain Top 5 Symptoms of ‘Breakthrough’ COVID-19 White House Warns COVID-19 Cases Could Double Late This Year Are Boosted Americans More Likely To Catch COVID-19? The study found that vaccinated people living with HIV have a 28% higher risk of developing a "breakthrough" COVID infection compared to those who don't have the AIDS-causing virus. That’s the bad news. But there's good news, too: The overall risk for COVID infection among people vaccinated with at least the two primary doses remains low, regardless of their HIV status. “We thought we might see an increase in the risk of breakthrough in people with HIV because of the impact of HIV on the immune system and the role of the immune system in responding to vaccination and infection from a virus like SARS-Cov-2," reasoned study author Keri Althoff. So, the researchers weren't surprised to find "that about 4 in 100 people with HIV experience a breakthrough, compared to 3 in 100 people without HIV," said Althoff, an associate professor in the Johns Hopkins School of Public Health epidemiology department. But it was a relief, she said, to see that nine months after vaccination, "the rate and risk of breakthrough is low among vaccinated people with and without HIV" -- around 4% in each group. Her team analyzed data on nearly 114,000 COVID-vaccinated men and women, of whom 33,000 had HIV. Most were 55 years and up, 70% were white, and more than 9 in 10 were men. The authors focused on COVID risk during the latter half of 2021, when the more contagious Omicron variant emerged. Althoff noted that breakthrough infections were higher across the board -- regardless of HIV status -- in December, when Omicron became the dominant strain. Beyond identifying the 28% higher risk for a breakthrough infection among those with HIV, the researchers noted that certain individuals with HIV faced a higher infection risk than others. They included people under age 45, compared with those between 45 and 54. Risk was also higher among those who had not received a third (or booster) dose, and those with a prior infection. Risk of breakthrough infection in folks with HIV also increased as their T-cell counts dropped. According to the U.S. National Library of Medicine, T-cells are critical infection-fighting white blood cells which are typically attacked by HIV. (When an HIV patient's T-cell count falls to an extremely low level, it is often a sign of transition to full-blown AIDS.) Althoff said she and her colleagues "hypothesize that HIV-induced immune dysfunction may be playing a role in vulnerability to breakthrough COVID-19 illness." For that reason, boosters may be critical for such patients, she said. Currently, Althoff pointed out, third-dose boosters are recommended for those whose HIV is either untreated or advanced. "To increase protection against breakthrough infections, all people with HIV may need an additional dose in their primary series," she noted. That thought was echoed by Dr. Joel Blankson, a professor of medicine at Johns Hopkins Medicine, who was not part of the study. Because the study showed a decrease in breakthrough infections in patients who had received a third vaccine dose, "it is important that people living with HIV get a booster dose when they are eligible," Blankson said. The U.S. Centers for Disease Control and Prevention has COVID vaccine guidelines here. Additional research by Althoff's team suggests that hospitalization risk for breakthrough cases is higher among HIV-positive people compared to those without HIV. (Those findings are still under peer review and are not yet published.) Her advice to those with HIV: "Get vaccinated. Get boosted. Keep living your life and scale up and down your mitigation strategies -- mask-wearing, attending indoor gatherings, etc. -- based on the amount of COVID-19 transmitting in your community, and your personal health status." Dr. Thomas Gut is associate chair of medicine at the Zucker School of Medicine at Hofstra/Northwell in New York City. "The HIV-linked risk of reinfection is somewhat expected," said Gut, who had no role in the study. "In many other infectious diseases besides COVID, it's been known that patients with HIV do tend to have higher risk of both getting sick and having poorer outcomes." But patients with HIV "that have strong immune cell counts have traditionally been known to be better protected from infections compared to those with low immune system counts," he added. "It appears that COVID reinfection risk follows this same pattern." Therefore, Gut said, it is important to keep HIV infection under control as best as possible. The findings are in the June 7 issue of JAMA Network Open. More information There's more on HIV status and COVID-19 at HIV.gov. SOURCES: Keri N. Althoff, PhD, MPH, associate professor, epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore; Joel N. Blankson, MD, PhD, professor, medicine, Johns Hopkins Medicine, Baltimore; Thomas Gut, DO, associate chair, medicine, and director, ambulatory care services, Zucker School of Medicine at Hofstra/Northwell, Staten Island, N.Y.; JAMA Network Open, June 7, 2022 Copyright © 2022 HealthDay. All rights reserved.

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