Why You Can’t Get the Omicron Booster If You’ve Never Been Vaccinated Against COVID-19 You need to complete your primary COVID-19 vaccination first. https://www.prevention.com/health/a41193176/omicron-booster-covid-vaccine-first/ In short: “It’s very simple: The studies were not done on the Omicron booster as a primary vaccination series,” says William Schaffner, M.D., an infectious disease specialist and professor at the Vanderbilt University School of Medicine. Because of this, the booster is only authorized by the FDA as an additional shot—not the main vaccine, he says. The dosage is also different for the booster vs. original vaccination series, points out Amesh A. Adalja, M.D., a senior scholar at the Johns Hopkins Center for Health Security. “The booster is of a lower dose and designed to augment protection after the primary vaccine series,” he says. “It builds on prior immunity and was not designed to be stand-alone.” It’s also “unclear” how much protection you’d get from the Omicron booster without going through the primary vaccination series first, he says.
Research on improved Covid vaccines continues... Experimental COVID-19 vaccine could outsmart future variants - Los Angeles Times https://www.latimes.com/science/sto...cine-may-outsmart-future-coronavirus-variants The new COVID-19 booster shots going into arms across the country are prized for their ability to recognize the distinctive spike protein shared by BA.4 and BA.5, the Omicron strains that currently account for nearly 90% of coronavirus specimens now circulating in the U.S. But sooner or later, mutations in the spike protein will allow the virus to slip past the antibodies that are trained to recognize its predecessors. The boosters may still protect people from becoming seriously ill, but they’ll become less effective at preventing infections in the first place. An experimental vaccine aims to solve that problem by priming the immune system to recognize both the spike protein and a second — and far more stable — viral protein. When tested in small animals, this bivalent vaccine provided stronger protection than alternatives that targeted only one of the proteins. And, although the vaccine’s design was based on an early coronavirus strain from Wuhan, China, it remained effective against the Delta and Omicron variants. “We think of it as a one-time solution for all the COVID variants,” said Haitao Hu, an immunologist at the University of Texas Medical Branch and senior author of a study describing the vaccine in Wednesday’s edition of the journal Science Translational Medicine. Other scientists who weren’t involved in the study agreed that if the vaccine works as well in humans as it did in mice and hamsters, it could help us stay a step ahead of the coronavirus. “It’s a great idea,” said Dr. Paul Offit, a virologist and immunologist at the University of Pennsylvania who wasn’t involved in the study. “You could have argued that we should have done this at the beginning.” The current COVID-19 vaccines have saved an estimated 19.8 million lives around the world. Yet as the virus has evolved, their effectiveness in preventing infections has lessened, meaning more illness, more time away from work and school, and more people at risk of developing long COVID. The situation has forced scientists to play catch-up with the variants, Hu said: “You’re always one stage behind.” The spike protein on the SARS-CoV-2 virus is in some ways the pandemic’s double-edged sword. It’s the key target of all four COVID-19 vaccines currently available in the U.S. But it’s also the part of the virus most likely to take advantage of random mutations that allow it to dodge the immunity those vaccines are intended to provide. There’s a reason why the spike protein, or “S” in virology shorthand, is so susceptible to evolutionary pressure: It’s the part of the virus that initiates an infection by entering a host cell. If the spike can’t do its job, the virus can’t survive. The second target of the experimental vaccine is the nucleocapsid protein, known as “N.” It’s situated in the virus’ core and has little reason to change. But once inside a host cell, it plays an essential role in allowing the coronavirus to make copies of itself. Hu and his colleagues used the same mRNA technology as the Pfizer-BioNTech and Moderna vaccines to encode instructions for making harmless copies of both the S and N proteins. Once those copies are made, the immune system recognizes them as threats and learns to respond accordingly. The researchers began their tests by injecting small groups of mice with vaccines that targeted only the N protein. The animals mounted an immune response, but only a modest one, Hu said. Exposing cells to N did not trigger the production of neutralizing antibodies. The study authors expected this, as N isn’t involved in helping the virus barge its way into a host cell. The exposure did, however, induce a strong T-cell response, which helps clear the virus from the cell. Next, the researchers injected animals with a bivalent vaccine that targeted S and N at the same time. The immune response was much stronger: No viral RNA was detected in the lungs of the eight mice that received the bivalent vaccine. By contrast, among eight mice immunized with a shot that targeted only S, seven had detectable amounts of viral RNA. Additional tests were conducted in hamsters that were exposed to the Delta variant. The results were similar: The viral load was undetectable in animals that received the combination vaccine, and their lung pathology was clear. Compared with hamsters that got the S-only vaccine, they also had less virus in their upper respiratory tracts, which could make them less likely to spread the virus to others. Hamsters exposed to the Omicron variant fared better with the bivalent vaccine as well. Four of five hamsters who received it had no detectable virus, compared with just one of five hamsters that were vaccinated with a shot that targeted only S. The animals that got the bivalent vaccine had no lung damage, while those that got the S-only vaccine developed lesions on their lungs. The bivalent vaccine also reduced viral loads in the hamsters’ upper respiratory tracts. The Texas team isn’t the first to go after the spike and nucleocapsid proteins at the same time. ImmunityBio of Culver City has developed a COVID-19 vaccine with a similar structure that’s currently in clinical trials in South Africa. The new study “confirmed that when you have S plus N, you’re able to have multivariant protection,” said Dr. Patrick Soon-Shiong, ImmunityBio’s executive chairman. (Soon-Shiong also owns the Los Angeles Times.) The S protein “gives you a good antibodies, and N gives you amazing T cells,” he said. “It’s the interplay between the antibodies and the T cells — by having both, you get the best of both worlds.” One thing the new study did not address is how long the benefits of the combination vaccine would last, said Stanley Perlman, a microbiologist and immunologist at the University of Iowa. The animals were tested two weeks after receiving their final dose, and the study authors acknowledged that longer experiments were needed to gauge the vaccine’s longevity. Hu said his team’s next step is to study the vaccine in nonhuman primates. If all funding and approvals come through, that could be completed within six months, and if the results are good, human trials would be next, he said.
Brazil approves Pfizer vaccine for children as young as six months https://www.reuters.com/business/he...vaccine-children-young-six-months-2022-09-17/
America is skeptical of the ‘dark horse’ COVID vaccine others abroad can’t get enough of https://fortune.com/well/2022/09/17...oroanvirus-pandemic-epidemic-endemic-cdc-fda/ Nearly 225 million Americans are considered fully COVID vaccinated by the U.S. Centers for Disease Control and Prevention, meaning they’ve received two or more doses of a vaccine. The number who’ve been fully vaccinated with Novavax, the latest vaccine to receive approval from U.S. health officials: a mere 6,278. The traditional protein-based vaccine, approved by U.S. health officials in July, was intended to win the hearts and minds of Americans who were hesitant to receive mRNA COVID vaccines Pfizer and Moderna, claiming that the technology was too new to be considered safe. “For those waiting for a COVID-19 vaccine built on a different technology, now is the time to get vaccinated,” CDC Director Dr. Rochelle Walensky said this summer. But for the 20% of Americans who remain unvaccinated, hesitancy about the safety of mRNA vaccine technology was likely just an excuse, experts say, as Novavax was formulated using the same technology as the flu vaccine—and uptake is still dismal. However hesitant Americans are about Novavax, for whatever reasons, the situation is quite the opposite elsewhere. The vaccine has been approved in 38 other countries, including Australia, France, Ireland, Italy, Korea, and the U.K., according to the World Health Organization. And Japan and Australia have approved the vaccine for usage as a booster dose, according to the Journal of American Medical Association. “It’s been attractive for a long time,” Dr. John Swartzberg, a professor at the Division of Infectious Diseases and Vaccinology at the University of California, Berekely’s School of Public Health, told Fortune, adding that the manufacturing issues delayed its U.S. debut. “What excited some people about it is the fact that it’s very similar to a lot of vaccines produced in the past,” Swartzberg said. “Protein vaccines have been used for decades. For some people, that gives them a degree of comfort, based upon emotion and not science.” Novavax has the potential to offer longer, broader protection than current mRNA vaccines, Dr. Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP), told Fortune. But more data on the vaccine is needed to determine the length of protection it offers, as well as its performance against Omicron subvariants. “I think it could be a better vaccine,” Osterholm said, though he cautioned that, in the early days of mRNA COVID vaccines, society had “unbridled expectations that ultimately didn’t pan out,” such as the vaccines preventing infection. Like mRNA vaccines, Novavax protects against severe COVID outcomes like hospitalization and death. But it doesn’t prevent infection or transmission, according to Yale Medicine. Maryland-based Novavax began developing its COVID vaccine in 2020, during Operation Warp Speed, but manufacturing difficulties slowed progress. Countries began granting the vaccine approval in November. In the U.S., the two-dose shot series is approved for those 12 and older, with shots occurring three to eight weeks apart. Side effects are similar to mRNA COVID vaccines and include tenderness, pain, and/or swelling at the injection site, fatigue, muscle pain, joint pain, headache, nausea, vomiting, and/or fever, according to Yale Medicine. As is the case with mRNA COVID vaccines, myocarditis—a rare form of heart inflammation—has been reported, though rarely. Dr. Bali Pulendran, professor of microbiology and immunology at Stanford University, told Fortune he isn’t sure why the U.S. hasn’t yet approved Novavax for use as a booster, giving those who’ve received a two-dose mRNA series another option, aside from newly approved Omicron mRNA vaccines. The U.S. Food and Drug Administration didn’t immediately respond to Fortune’s question as to why the U.S. hasn’t approved the vaccine for use as a booster, though other countries have. “It’s a terrific vaccine, and I do hope people get access to it if they wish to,” Pulendran said.
Bivalent mRNA-1273.214 Elicits Better Response Against Omicron Booster dose of mRNA-1273.214 elicits more neutralizing antibodies against omicron compared with mRNA-1273, with no new safety concerns https://consumer.healthday.com/biva...a-1273-214-better-for-omicron-2658304050.html
A strong fall COVID booster campaign could save 90,000 U.S. lives and avoid more than 936,000 hospitalizations, study finds https://www.marketwatch.com/story/a...-000-hospitalizations-study-finds-11664978015
Pfizer COVID vaccine clears Japan panel for use with young children https://www.reuters.com/business/he...pan-panel-use-with-young-children-2022-10-05/
Houston doctors get approval for low-cost COVID vaccine abroad https://houston.innovationmap.com/indovac-maria-elena-bottazzi-peter-hotez-approval-2658400939.html A Houston-born COVID-19 vaccine has gotten the go-ahead to be produced and distributed in Indonesia. PT Bio Farma, which oversees government-owned pharmaceutical manufacturers in Indonesia, says it’s prepared to make 20 million doses of the IndoVac COVID-19 vaccine this year and 100 million doses a year by 2024. This comes after the vaccine received authorization from the Indonesian Food and Drug Authority for emergency use in adults. With more than 275 million residents, Indonesia is the world’s fourth most populous country. IndoVac was created by the Texas Children’s Hospital Center for Vaccine Development and Baylor College of Medicine. Drs. Peter Hotez and Maria Elena Bottazzi lead the vaccine project. Bio Farma is licensing IndoVac from BCM Ventures, the commercial group at the Baylor College of Medicine. “Access to vaccines in the developing world is critical to the eradication of this virus,” Hotez, co-director of the Texas Children’s Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor College of Medicine, says in a news release. Aside from distributing the vaccine in Indonesia, Bio Farma plans to introduce it to various international markets. “The need for a safe, effective, low-cost vaccine for middle- to low-income countries is central to the world’s fight against the COVID-19 pandemic,” says Bottazzi, co-director of the Texas Children’s Hospital Center for Vaccine Development and associate dean of the National School of Tropical Medicine at Baylor. “Without widespread inoculation of populations in the developing world, which must include safe, effective booster doses, additional [COVID-19] variants will develop, hindering the progress achieved by currently available vaccines in the United States and other Western countries.” Bio Farma says it has completed Phase 1 and Phase 2 clinical trials for IndoVac and is wrapping up a Phase 3 trial. IndoVac is a version of the patent-free, low-cost Corbevax vaccine, developed in Houston and dubbed “The World’s COVID-19 Vaccine.” The vaccine formula can be licensed by a vaccine producer in any low- or middle-income country, which then can take ownership of it, produce it, name it, and work with government officials to distribute it, Hotez told The Texas Tribune in February. Among donors that have pitched in money for development of the vaccine are the Houston-based MD Anderson and John S. Dunn foundations, the San Antonio-based Kleberg Foundation, and Austin-based Tito’s Vodka. “During 2022, we hope to partner with the World Health Organization and other United Nations agencies to vaccinate the world. We believe that global vaccine equity is finally at hand and that it is the only thing that can bring the COVID pandemic to an end,” Hotez and Bottazzi wrote in a December 2021 article for Scientific American.
They need to push heavy (become more aggressive) about other vaccines now such as FLU, Prevnar, and Polio Vaccines. I think it was Australia that recently had its worst Influenza infection season in five years. https://www.nbcnews.com/health/health-news/australia-flu-season-warning-sign-us-this-year-rcna40123 As for myself, I'm not old enough for Prevnar but I have an exception because pneumonia almost killed me in the fall of 2016 after I vacation, and then became infected in an area that was having an outbreak of Pneumonia. Thus, I'm now immune-compromise from that past illness... I will soon be getting the FLU vaccine and have already had the Prevnar vaccine considering I'm back to traveling again now that borders have re-open in this Covid Pandemic. These vaccines do not prevent getting infected with the FLU or Pneumonia but they are very effective in preventing hospitalization or death. wrbtrader