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J&J Suffers New Warning Label, Woodcock: “Most People are Going to Get COVID”

The U.S. Food and Drug Administration added another warning to the regulatory agency’s fact sheet for Johnson & Johnson’s COVID-19 vaccine. In other…

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J&J Suffers New Warning Label, Woodcock: “Most People are Going to Get COVID”

Although the COVID-19 vaccines are very effective and relatively safe, with the huge numbers of people getting vaccinated in a relatively short period, side effects and reactions are more pronounced. The U.S. Food and Drug Administration (FDA) added another warning to its fact sheet for the Johnson & Johnson vaccine. For that and more COVID-19 news, continue reading.

J&J Vaccine Gets Additional Label Warning About Bleeding Disorder

The FDA informed Johnson & Johnson that adverse-event reports indicated a possible increased risk of immune thrombocytopenia within 42 days after vaccination with their COVID-19 vaccine. The symptoms include bruising or excessive or unusual bleeding. As a result, they modified the fact sheet supplied to healthcare providers with the vaccine, particularly for people with existing medical conditions that include low platelets. The vaccine had been previously associated with thrombosis with thrombocytopenia syndrome (ITS), a rare but serious type of blood clotting. The population at the highest risk was women ages 30 to 49.

Pfizer-BioNTech and J&J Boosters to Be Tested for Patients with HIV

A research project by South Africa’s Wits Reproductive Health and HIV Institute will evaluate the safety and impact of different doses of the Johnson & Johnson and PfizerBioNTech COVID-19 vaccines as boosters for people infected with HIV as well as the broader population. The study will recruit approximately 300 healthcare workers, with about a third who are HIV positive. In South Africa, about 8.2 million people, or 13% of the population, are HIV positive. And it’s not clear how effective the vaccines are in creating an immune response in immunocompromised people.

“There are a number of concerns about immunogenicity in people with HIV, particularly people with less well-controlled HIV,” said Dr. Lee Fairlie, head of child and maternal health at the institute. “That is really an area of importance in SA. We really need to know: are we doing enough for people with HIV?”

FDA’s Woodcock: “Most people are going to get COVID.”

As the Omicron variant rips through the U.S., top health officials have noted that the variant is so contagious that if you come into contact with it, you’re likely to catch it. Acting FDA Commissioner Dr. Janet Woodcock, responding to a question from Sen. Mike Braun before a Senate Health, Education, Labor, and Pensions Committee hearing, said, “I think it’s hard to process what’s actually happening right now, which is: Most people are going to get COVID. And what we need to do is make sure the hospitals can still function, transportation, you know, other essential services are not disrupted while this happens.”

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and President Joe Biden’s chief medical adviser, told J. Stephen Morrison, senior vice president of the Center for Strategic and International Studies, “Omicron, with its extraordinary, unprecedented degree of efficiency of transmissibility, will ultimately find just about everybody. Those who have been vaccinated … and boosted would get exposed. Some, maybe a lot of them, will get infected but will very likely, with some exceptions, do reasonably well in the sense of not having hospitalization and death.” However, he added, people who are not vaccinated are “going to get the brunt of the severe aspect of this.”

Study: Cannabinoids Prevent COVID-19 Infection

A study published by Oregon State University researchers found that specific cannabinoids, compounds found in cannabis, can block SARS-CoV-2 from entry into cells. The two cannabinoid acids found in hemp varieties of cannabis are cannabigerolic acid (CBGA) and cannabidiolic acid (CBDA). They both can bind to the spike protein of the virus, preventing it from entering cells and causing infections. The research was published in the Journal of Natural Products.

Richard van Breeman, Ph.D., who led the research, said, “These cannabinoid acids are abundant in hemp and in many hemp extracts. They are not controlled substances like THC, the psychoactive ingredient in marijuana, and have a good safety profile in humans.”

South Korea Approves Novavax COVID-19 Vaccine

Drug regulators in South Korea granted final authorization to Novavax’s COVID-19 vaccine in adults. That makes it the fifth COVID-19 vaccine available in South Korea. The vaccine is the first protein-based COVID-19 vaccine approved in South Korea. It will be manufactured and marketed in the country by SK bioscience. SK bioscience has a deal with the South Korean government to supply 40 million vaccine doses. To date, the vaccine has received conditional marketing authorization in the European Union and emergency use listing (EUL) from the World Health Organization (WHO) under the brand name Nuvaxovid. It has received emergency use authorization (EUA) in India, Indonesia, and the Philippines.

Is Omicron Pushing the Pandemic to an Endemic Stage?

Source: BioSpace

Because the Omicron variant is so infectious and spreads so quickly, many public health officials and immunologists believe—or at the very least, hope—that it is pushing the COVID-19 pandemic toward an endemic stage. Dr. Marco Cavaleri, head of vaccine strategy for the European Medicines Agency (EMA), said Tuesday that the natural immunity created by Omicron might be speeding the progress toward endemicity. Endemicity is when there is enough immunity in a population, either from vaccination or previous infectious, transmissions, hospitalizations, and deaths. The disease resembles that of the cold and flu.

“With the increase of immunity in population—and with Omicron, there will be a lot of natural immunity taking place on top of vaccination—we will be fast-moving towards a scenario that will be close to endemicity,” Cavaleri told Al Jazeera.

Cavaleri also questioned the need for a fourth COVID-19 vaccine dose, or second booster, saying that approach was not “sustainable,” adding, “It is important that there is a good discussion around the choice of the composition of the vaccine to make sure that we have a strategy that is not just reactive … and try to come up with an approach that will be suitable in order to prevent a future variant.”

BioSpace source:

https://www.biospace.com/article/j-and-j-vaccine-slapped-with-another-warning-label-and-more-covid-19-news

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