Novavax Covid vaccine approved for use in over-18s in UK Nuvaxovid is similar to flu jab and may have reduced side-effects, which could persuade vaccine holdouts Novavax’s offering is a protein-based vaccine that usesmore established technologythan some others, similar to the flu jab and routine childhood vaccines against whooping cough or meningococcal infection. There is early evidence that it could have reduced side-effects, with trial data appearing to show lower rates of fatigue, headaches and muscle pain. Public health experts hope that these factors could convince as yet unvaccinated people who are sceptical of new technology or worried about side-effects from other vaccines to get a shot. https://www.theguardian.com/society...id-vaccine-approved-for-use-in-over-18s-in-uk
Is there any specific reason that this product is not widely available in the USA? Does the Fouch and Co. get paid for Novavax? Conflict of interest? Is this an mRNA gene-therapy drug or is it classical vaccine? These questions and more are addressed in Dr. Pete's excellent interview below: You won't see this on Stelter's 'show'. enjoy -
It appears that Johnson & Johnson is no longer really pursuing the Covid vaccine business. "Temporarily" stopping the production of the Covid vaccine for months is not a "temporary" measure. They have converted their one plant producing the Covid vaccine to manufacture other vaccines. They have stopped aggressively pursuing deals to license other plants to manufacture their Covid vaccine after the fiasco with the Baltimore plant. This is coupled with that there is a huge existing stockpile of J&J Covid vaccines which people are refusing to take -- preferring other more effective alternatives. Johnson & Johnson temporarily stops COVID vax production: report https://nypost.com/2022/02/08/johnson-johnson-temporarily-stops-covid-vaccine-production/ Johnson & Johnson stopped production of its single-shot COVID-19 vaccine at the only plant making usable doses late last year, according to a report Tuesday. The stoppage at the plant in the Netherlands is temporary — with production of the vaccine expected to resume sometime in March, the New York Times reported, citing sources close to the matter. While it’s unclear if the shutdown that began late last year has had an impact on vaccine availability, it could slash Johnson & Johnson’s supply by a few hundred million doses, one source told the newspaper. Other facilities have been tasked to produce the J&J vaccine, but they either still await regulatory approval or weren’t yet manufacturing it, the Times reported. Johnson & Johnson had already fallen behind on deliveries of its one-shot COVID-19 vaccine to poorer countries. The facility in the Dutch city of Leiden has instead shifted its efforts to produce an experimental vaccine to treat an unrelated virus, according to the report. The plant has since been manufacturing a vaccine against respiratory syncytial virus (RSV) to be used in a clinical trial in older adults in wealthy countries, a source close to the matter told the Times. The vaccine is not expected to be available for several years even if it’s proven effective. RSV, which causes mild, cold-like symptoms, kills an estimated 14,000 older Americans each year. Johnson & Johnson is one of several companies trying to develop the first vaccine against it. Johnson & Johnson’s COVID-19 vaccine has been linked to a rare but dangerous blood-clot disorder and some studies found it performs worse than its Pfizer and Moderna counterparts. Still, poorer countries rely on Johnson & Johnson’s version since it doesn’t require ultra-cold storage. The Leiden plant had the capacity to produce more than 50 million doses per month, the Times reported. Once restarted, doses made at the plant won’t be shipped until May or June, according to the report. Johnson & Johnson hired a contractor to start producing its vaccine at a Baltimore plant capable of producing a billion doses per year, but regulators shut it down last April. It then restarted in August, but regulators haven’t yet found it can operate in compliance with manufacturing standards, officials told the Times. The Food and Drug Administration is insisting on reviewing individual batches of the vaccine before shipment and regulators haven’t approved any made since the factory reopened, a spokesman for the contractor said. But plans are underway for J&J to start production of its vaccine at two other facilities in late spring, including one in India and another in North Carolina. A J&J spokesman told the Times the company was “working day and night” to fight the COVID-19 pandemic — with millions of doses stockpiled away in inventory. The company said last summer it planned to deliver 1 billion doses of the one-shot treatment in 2021, but fell far short with roughly 400 million doses, one source close to the matter told the Times.
"The next culture war": Vaccines for young kids https://www.axios.com/covid-vaccines-reluctant-parents-e17b51cf-fded-4761-b942-215f502771e4.html Pfizer and federal officials are scrambling to speed up COVID vaccines for kids under 5 — but polls indicate plenty of parents may be on the fence about getting their child vaccinated right away. Why it matters: Officials are trying to get first shots into the littlest arms to protect against severe disease and hospitalization — which, while rare for young kids, is still a real threat. But parents of younger children are generally more cautious, which for some could mean a race to get the shots once their kids are eligible while others choose to wait. "When I looked at these numbers, I thought: 'Buckle up, PTAs. Toddler vaccines are the next culture war,'" John Gerzema, CEO of The Harris Poll, told Axios. In a Harris poll of 306 parents of kids under 5 provided exclusively to Axios, 73% of vaccinated parents said they're likely to vaccinate their kids under 5, while only 35% of unvaccinated parents would. On the flip side, 65% of unvaccinated parents said they are unlikely to get their kids under 5 vaccinated, while just 27% of vaccinated parents agreed. Between the lines: It's hard to get an exact read on this question in polling, because once parents of kids under 5 are separated out in the data, the sample size gets small and the margins of error get large. But the polling organizations Axios spoke with said their numbers are large enough to offer a meaningful picture of parents' vaccine sentiment. By the numbers: When digging deeper into the data, Harris found that more women (47%) said they were unlikely to want their kids to get the shot than men (31%). Almost half of the suburban respondents (49%) said they were unlikely to want the shot for their kids — almost as high as people from rural areas (57%) — compared to just 25% in urban areas. More of those identifying as independents (57%) than Republicans (38%) or Democrats (26%) said they were unlikely to want the shot for their kids under 5. "That doesn't really fit the mold. The unlikely are usually rural, Republicans, [making] under $50K," Gerzema said. These results suggest that suburban moms are "maybe having a pause on this and thinking should we just wait a couple of weeks on this?" Other polls found more evidence of reluctant parents. The Axios/Ipsos Coronavirus Index, which includes responses from 181 parents of children under 5 across three waves of polling since the beginning of the year, found that 44% of parents with kids under 5 said they were not very or not at all likely to get their kids vaccinated as soon as possible, while 41% said they would be likely. The KFF Vaccine Monitor released last week, which included 162 responses from parents, found just three in 10 parents of children under 5 said they'd get their child vaccinated right away once a vaccine is approved. That was an improvement from one in five in July. The bottom line: If and when Pfizer's vaccines become available for the youngest kids, officials will have a job ahead of them convincing many parents to take advantage of them, even after two years of waiting.
Just start pumping it into Walmart ventilation systems and the pandemic will be over... Researchers confirm newly developed inhaled vaccine delivers broad protection against SARS-CoV-2, variants of concern https://brighterworld.mcmaster.ca/a...ction-against-sars-cov-2-variants-of-concern/ Scientists at McMaster University who have developed an inhaled form of COVID vaccine have confirmed it can provide broad, long-lasting protection against the original strain of SARS-CoV-2 and variants of concern. The research, recently published in the journal Cell, reveals the immune mechanisms and significant benefits of vaccines being delivered directly into the respiratory tract, rather than by traditional injection. The laboratory and the researchers are part of McMaster’s Global Nexus for Pandemics and Biological Threats. Because inhaled vaccines target the lungs and upper airways where respiratory viruses first enter the body, they are far more effective at inducing a protective immune response, the researchers report. The reported preclinical study, which was conducted on animal models, has provided the critical proof of concept to enable a Phase 1 clinical trial that is currently under way to evaluate inhaled aerosol vaccines in healthy adults who had already received two doses of a COVID mRNA vaccine. The tested COVID vaccine strategy was built upon a robust tuberculosis vaccine research program established by Zhou Xing, a co-lead author of the new study and a professor at the McMaster Immunology Research Centre and Department of Medicine. “What we’ve discovered from many years’ research is that the vaccine delivered into the lung induces all-around protective respiratory mucosal immunity, a property that the injected vaccine is lacking,” Xing says. Currently authorized COVID vaccines are all injected. “We wanted, first and foremost, to design a vaccine that would work well against any variant,” explains the study’s co-lead author Matthew Miller, an associate professor at McMaster’s Michael G. DeGroote Institute for Infectious Disease Research. The McMaster COVID vaccine represents one of only a handful developed in Canada. The urgent work is a critical mission of Canada’s Global Nexus for Pandemics and Biological Threats, which is based at McMaster. Researchers compared two types of adenovirus platforms for the vaccine. The viruses serve as vectors that can deliver vaccine directly to the lungs without causing illness themselves. “We can remain ahead of the virus with our vaccine strategy,” says Miller. “Current vaccines are limited because they will need to be updated and will always be chasing the virus.” Both types of the new McMaster vaccine are effective against highly transmissible variants because they are designed to target three parts of the virus, including two that are highly conserved among coronaviruses and do not mutate as quickly as spike. All COVID vaccines currently approved in Canada target only the spike protein, which has shown a remarkable ability to mutate. “This vaccine might also provide pre-emptive protection against a future pandemic, and that’s really important because as we’ve seen during this pandemic – and as we saw in 2009 with the swine flu – even when we are able to rapidly make a vaccine for a pandemic virus, it’s already way too late. Millions of people died, even though we were able to make a vaccine in record time,” says Miller. “We have revealed in our report that besides neutralizing antibodies and T cell immunity, the vaccine delivered into the lungs stimulates a unique form of immunity known as trained innate immunity, which is able to provide very broad protection against many lung pathogens besides SARS-CoV-2,” Xing adds. In addition to being needle and pain-free, an inhaled vaccine is so efficient at targeting the lungs and upper airways that it can achieve maximum protection with a small fraction of the dose of current vaccines – possibly as little as 1 per cent – meaning a single batch of vaccine could go 100 times farther, the researchers say. “This pandemic has shown us that vaccine supply can be a huge challenge. Demonstrating that this alternative delivery method can significantly extend vaccine supply could be a game changer, particularly in a pandemic setting,” says Brian Lichty, an associate professor in the Department of Medicine who co-led the preclinical study along with Miller, Xing and the senior trainees Sam Afkhami and Michael D’Agostino, who are the joint first authors of the study. The vaccines were manufactured at the Robert E. Fitzhenry Vector Laboratory at McMaster University. The research is funded by a CIHR COVID-19 Rapid Response grant.
Covid has made it clear: the likes of Pfizer, in thrall to shareholders, only really care about their huge profits https://www.theguardian.com/commentisfree/2022/feb/08/big-pharma-global-vaccine-rollout-covid-pfizer
FDA postpones advisory panel meeting on Pfizer Covid-19 vaccine for younger children https://www.wral.com/fda-postpones-...vid-19-vaccine-for-younger-children/20132624/ The US Food and Drug Administration announced Friday that it is postponing the meeting of its Vaccines and Related Biological Products Advisory Committee, originally scheduled for February 15, as "new data have recently emerged" regarding Pfizer and BioNTech's emergency use authorization request for their Covid-19 vaccine for children younger than 5. "This will give the agency time to consider the additional data, allowing for a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines. We will provide an update on timing for the advisory committee meeting once we receive additional data on a third dose in this age group from the company's ongoing clinical trial and have an opportunity to complete an updated evaluation," acting FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement.
Fauci says Covid booster shots may have to be taken every five years rather than annually https://www.independent.co.uk/news/world/americas/fauci-five-years-covid-boosters-b2013403.html
And on the other hand... COVID booster protection likely wanes after 4 months, CDC says https://nypost.com/2022/02/11/covid-booster-protection-likely-wanes-after-4-months-cdc-says/ Third shots of the coronavirus vaccines become significantly less likely to protect against serious illness after about four months, according to a new study released Friday. The effectiveness of the third booster doses against hospitalizations during the Omicron era of the pandemic dropped from 91 percent in the first two months after a third dose to 78 percent around the fourth month, data from the Centers for Disease Control and Prevention suggest. Effectiveness against emergency department or urgent care visits in that same period went from 87 percent in two months to 66 percent by the fourth month after the third dose – and only 37 percent after about five months, the data show. In a summary of the study, the CDC recommended all eligible people “remain up to date with recommended COVID-19 vaccinations to best protect against COVID-19-associated hospitalizations and [emergency and urgent care] Dr. Anthony Fauci, the White House’s chief medical adviser, recently told the Financial Times said he foresees a time where vaccinations and previous infections will mean fewer COVID-19 restrictions. Regular boosters may not be needed for everyone, he said. “It will depend on who you are,” Fauci said. “But if you are a normal, healthy 30-year-old person with no underlying conditions, you might need a booster only every four or five years. The study, conducted with cases across 10 states from Aug. 26, 2021 to Jan. 22, 2022, suggests vaccine protection is stronger overall against hospitalizations than it is for emergency visits. The vaccines also appeared to be more potent when the Delta strain accounted for a majority of cases than when the Omicron variant did. The new data backed up previous studies that suggested the Pfizer and Moderna vaccines, in either two or three doses, was less effective in both the Omicron and Delta-dominant periods of the pandemic. The new research is limited though – the data didn’t distinguish between people who got a third dose as a booster shot or those who were immunocompromised and got three shots as part of their recommended dosages. It also didn’t have breakdowns of the effectiveness by age group or note if those tracked had underlying health conditions. The tracked cases don’t take into consideration coronavirus infections that weren’t medically reported nor did they confirm which variant of COVID was present in the cases. But the study suggested that two-doses of the vaccines during the Omicron-dominant period offered 69 percent effectiveness against emergency or urgent visits within two months yet only 37 percent at five months. A third dose boosted protection to 87 percent effectiveness within two months to 66 percent within four or five months to only 31 percent after five months, the data show. There was little data on those vaccinated for over five months, the CDC said. Among those hospitalized with COVID-19 like illness in the study, 43 percent were unvaccinated, 45 percent had gotten two doses and 12 percent had received three shots of one of the vaccines.