New study among First Nations Australians shows effective immune response after COVID-19 vaccines https://www.abc.net.au/news/2023-05...covid-vaccine-study-immune-response/102407328
The first line of vaccines was highly effective at restricting COVID-19’s damage https://theconversation.com/the-fir...ective-at-restricting-covid-19s-damage-206722
Johnson & Johnson COVID vaccine authorization revoked by FDA https://seekingalpha.com/news/39773...en-covid-vaccine-authorization-revoked-by-fda The US FDA has revoked the emergency use authorization for Johnson & Johnson Janssen unit's COVID vaccine. Janssen voluntarily requested the withdrawal on May 22. The company noted that the last lots purchased by the US Government have expired, there is no additional demand in the US, and they do not intend to update the strain composition for emerging variants. mRNA vaccines made by Moderna (MRNA) and Pfizer (PFE)/BioNTech (BNTX) account for almost all of the COVID shots administered in the US now.
Shouldn't the "Emergency Use Authorization" be revoked for all vaccine makers after the WHO recently stated it's no longer a global crisis ??? It's another way of saying that vaccines & omicron did their job. Regardless, after the remaining lots have reached their expiration dates...future lots will no longer be free and people will need to pay out of pocket or have medical insurance to take care of the bulk of the expense if someone needs to be vaccinated prior to traveling to a place that has Covid outbreak while the rest of the world is not. wrbtrader
The updated Covid vaccine formulation available this fall will target the most recent XBB.1.5 variant. Another updated COVID vaccine could be available in the fall. Here’s what we know https://news.yahoo.com/another-updated-covid-vaccine-could-134612866.html COVID-19 vaccines are due for another update and new formulas could be available in the U.S. by the fall, according to the Food and Drug Administration. But it’s not yet clear who would be advised to receive the updated shot. Updating the shots to target newer coronavirus omicron subvariants currently circulating in the U.S. — those of the XBB lineage — received unanimous support in a vote held at the FDA’s Vaccines and Related Biological Products Advisory Committee meeting on June 15. Now the FDA is advising vaccine manufacturers to develop COVID-19 shots with a formula targeting the XBB.1.5 subvariant. Meanwhile, Pfizer, Moderna and Novavax have already been developing updated COVID-19 vaccines in preparation for fall. The FDA committee’s recommendation comes after the mRNA COVID-19 vaccines made by Pfizer and Moderna were previously updated to include a component of their original vaccines and a second component targeting the omicron variant’s BA.4 and BA.5 strains. In April, these “bivalent” shots were authorized by the FDA as the main mRNA vaccines available in the U.S. for those 6 months and older — replacing the companies’ original, monovalent vaccines that are no longer authorized, McClatchy News previously reported. Why are the vaccines getting updated again? In recommending a new, monovalent COVID-19 vaccine composition, the FDA said the current bivalent vaccines aren’t as effective in protecting against the latest virus variants. “By several measures, including escape from antibody neutralization and waning protection, the currently available bivalent COVID-19 (Original plus Omicron BA.4/BA.5) vaccines appear less effective against currently circulating variants,” the FDA said. Omicron BA.4 and BA.5 are no longer spreading in the U.S., according to the latest Centers for Disease Control and Prevention data. When the FDA’s advisory committee met on June 15, it considered three subvariants — XBB.1.5, XBB.1.16 and XBB.2.3 — for the formula of COVID-19 vaccines in the fall before preference for XBB.1.5 was determined, according to the agency. As of early June, XBB sublineages made up more than 95% of COVID-19 variants spreading in the U.S., the FDA said. The latest CDC data shows the XBB.1.5 variant was the most dominant strain for the two-week period ending on June 10, making up 39.9% of cases. What comes next? The FDA will make an official decision soon on the vaccine composition to recommend to manufacturers, according to Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research. The official recommendation will be based on the discussion at the FDA’s advisory committee meeting and won’t come “as any surprise,” Marks said in a message shared to Twitter. Following the FDA’s official recommendation, the agency expects vaccine manufacturers to proceed with manufacturing their new shots, according to Marks. Then, Marks said, the companies will gather the data needed to “inform our ultimate FDA actions in order to have vaccines evaluated with our safety and effectiveness standards for availability in the September time frame.” Pfizer aims to have an updated COVID-19 vaccine candidate available before the fall begins, Faith Salamon, director of the company’s global media relations, said in a statement to McClatchy News. “To prepare for multiple scenarios, Pfizer has been producing several updated COVID-19 vaccines at-risk, including both monovalent and bivalent formulations targeting circulating Omicron XBB.1.5 sublineages,” Salamon said. Moderna also plans to ship out its updated vaccine, if approved, at the end of summer to be ready for fall, company spokesman Chris Ridley confirmed to McClatchy News. “We’ve been working for a few months to develop an effective, variant-targeting vaccine for the fall vaccination season,” Ridley said. “Based on our own monitoring and analysis, we’ve been developing and testing XBB-targeting vaccines at risk, including preclinical and clinical testing.” Moderna can “pivot quickly” when it comes to developing a new COVID-19 shot since it’s an mRNA vaccine, according to Ridley. A new COVID-19 vaccine formula can be developed in about 60 to 90 days for a new virus variant Novavax said it has also created a protein-based, monovalent COVID-19 targeting XBB.1.5 and plans to have it ready and available, if authorized, in the fall. The company is making the shots on a “commercial scale” and also seeks to ship out the vaccine across the globe, the release said. “We believe we are in a better position to offer an alternative vaccine choice for individuals worldwide,” the company said. At the FDA’s advisory committee meeting, animal immune response data on the updated vaccines were presented, as well as immune response data from one person given an updated vaccine, according to the agency. If the updated vaccines are authorized for the fall, it’s unknown who will be advised to get it until officials issue guidance. “I’m all for updating this vaccine, but I think we need to define...who really benefits from booster dosing? Because it’s not everybody,” Dr. Paul Offit, an FDA advisory committee member and pediatrician specializing in infectious diseases at the Children’s Hospital of Philadelphia, said at the meeting, according to NPR. About 70% of Americans have received the primary series of COVID-19 vaccines as of May 2023, according to the CDC, with just 17% in the U.S. also getting the bivalent booster dose.
Progress is being made on a universal vaccine for the flu. Similar progress is being made on a universal coronavirus vaccine. Better than an annual flu shot? Duke researchers developing longer-lasting flu vaccine Annual flu shots require some guesswork by public health experts. A universal shot being developed by Duke University researchers could offer more protection -- and fewer jabs in the arm. https://www.wral.com/story/better-t...veloping-longer-lasting-flu-vaccine/21231608/ One shot a year that targets the anticipated dominant strain of influenza. That’s the status quo for those looking to survive flu season. But what if you could get one shot every few years that targeted all of the flu strains at once? That’s the goal of Duke University scientists who are working on a universal flu vaccine. “What we’ve done is just simply ask the question: Is it possible to make an antibody that would bind to all sorts of flus, not just the flu of the season,” said Garnett Kelsoe, an immunology professor at Duke University School of Medicine. Kelsoe’s team, along with a group of researchers at Harvard University, have been working on the development of a universal flu vaccine for seven years. Recently, the team discovered a group of antibodies in several unrelated humans that target all types of influenza. The antibodies were also found in some animals. “It was quite rare actually,” Kelsoe said. “It was two antibodies out of about 8,000 that bound to all sorts of different kinds of flu — the flu that is circulating now, but also flu that has circulated in the past and kinds of flus that actually are only in animals.” The discovery, published late last year in the Proceedings of the National Academy of Sciences, could mean unprecedented protection against a virus that infects millions and kills thousands of people each year. According to the Centers for Disease Control and Prevention, the flu caused an estimated 31 million people to get sick and 21,000 deaths during the 2022-23 flu season. And on Wednesday, the North Carolina Department of Health and Human Services released data indicating that deaths related to the flu are on the rise in the state. Annual flu shots require some guesswork by public health experts who predict the prevailing flu strain. A universal shot, the thinking goes, could offer more protection and possibly reduce the severity of the illness, and perhaps reduce deaths. “The way that all human vaccines are developed right now is they’re developed for the strain that the World Health Organization basically bets is going to be the circulating strain the next year, so it’s always bet in advance. Sometimes they’re right, sometimes they’re not right,” said Kelsoe. To get the vaccines manufactured and into pharmacies on-time, the prediction has to be made several months in advance which leads to an average annual flu vaccine efficiency of about 50%. A universal flu vaccine is designed to be more of a “sure bet” by defending against a wider array of flu strains — not just those predicted by public health experts, Kelsoe said. After the researchers discovered the antibodies, the team at Harvard used what’s called cyro electron microscopy to determine where the antibody attaches to the flu virus. The researchers at Duke then introduced the antibodies to mice and injected them with the flu. “You can give the mice hugely lethal doses of influenza virus, and the mice survive,” Kelsoe said. “In fact, they don’t really get sick at all.” The recent rise in North Carolina flu deaths comes as the CDC says flu vaccinations are the lowest in the last five years. If people could get just one shot that protected against all strains rather than just one, it could greatly combat vaccine hesitancy, Kelsoe says. “If a shot is really good and it lasts for multiple years, you have great faith in that it’s terrific,” he said. “If you have to get a shot every year and it’s only about 50% effective, that reduces people’s faith. One of the goals of the universal vaccine is to regain people’s faith and the efficacy of vaccines.” The team will now move forward with their findings to test in primates sometime over the next two years. If the vaccine proves to be effective in primates, then human trials could begin. Kelsoe said it’s still important for people to get their annual flu shot while the universal vaccine is being developed. “Even the vaccines that are not 100% effective reduce sickness and significantly reduce death. They’re very, very valuable.”