Remember when African coutries were working to manufacture knock-off versions of the Moderna Covid vaccine because Moderna would not allow them to manufacture a low-cost version in Africa. Now Moderna is shipping entire Covid vaccine manufacturing facilities to Africa as shipping crates -- to allow the low cost manufacturing of its Covid vaccines. I wonder what this means for Moderna's operating margins -- especially when combined with dropping demand. New mRNA vaccine factory is made from shipping containers Each “BioNTainer” can produce 50 million COVID-19 vaccine doses per year. https://www.freethink.com/health/mrna-vaccine-factory German biotech company BioNTech is sending a modular mRNA vaccine factory to Rwanda to allow the country to produce more COVID-19 shots for Africa, in Africa — and perhaps one day help the continent easily vaccinate its citizens against other deadly diseases, too. The challenge: Africa manufactures less than 1% of the vaccines it uses, relying on other countries for the rest, and when the first COVID-19 vaccines were being made, wealthier countries scooped them up for their own citizens first, leaving Africans behind. Even though many African nations are now well-supplied with COVID-19 shots, getting doses from manufacturing sites elsewhere in the world to Africa is a challenge — many shots require a cold chain, and the farther they need to be transported, the greater the chances of that chain breaking. “The COVID-19 pandemic has exposed the need for significantly greater local production of vaccines and other essential products in all regions of the world, especially in Africa,” said Tedros Adhanom Ghebreyesus, the WHO’s director-general, in 2022. The idea: To increase vaccine production in Africa, Germany’s BioNTech — the company that designed one of the first mRNA COVID-19 vaccines with Pfizer — announced in February 2022 that it had designed a modular mRNA vaccine factory it dubbed a “BioNTainer.” This factory consists of two modules, each made from six shipping containers. In the first module, mRNA is produced and purified. In the second, it is made into a vaccine. Local partners can then package the mRNA vaccine into doses. The mRNA vaccine factory can be shipped via truck, train, or freighter and then assembled on site. It takes up about 8,600 square feet of space, and BioNTech says one factory can produce up to 50 million doses of its mRNA COVID-19 vaccine annually. What’s new? BioNTech has now finished building its first BioNTainer module in Europe and is preparing to ship it to Kigali, Rwanda, before the end of Q1 2023. It’s not clear when the second module will follow, but production of vaccines is expected to begin one year after it arrives. BioNTech will staff and run the factory itself at first, but the plan is to transfer the operation to locals to run independently. The company expects any mRNA vaccines made at the facility to be used domestically or exported to other members of the African Union at a not-for-profit price. Looking ahead: BioNTech’s goal is to set up two BioNtainers in Kigali before shipping others to Senegal and possibly South Africa — and these factories might not be limited to producing COVID-19 shots. BioNTech is currently developing mRNA vaccines for malaria, tuberculosis, and HIV, and if these shots prove effective, they could be manufactured in the same BioNTainer factories, too, thanks to mRNA vaccines’ unique flexibility.
FDA considers major shift in COVID vaccine strategy NPR - https://tinyurl.com/44vjvxjd The Food and Drug Administration is considering a major shift in the nation's COVID-19 vaccine strategy. The goal is to simplify vaccination against COVID and perhaps adopt an approach similar to what is used for the flu vaccine, with annual updates to match whatever strain of the virus is circulating. This is according to a federal official who spoke under the condition of anonymity because they were not authorized to speak publicly. NPR reported the proposed shift early Monday morning, and later Monday the FDA outlined it publicly in a set of documents releasedin advance of a meeting Thursday of the agency's Vaccine and Related Biological Products Advisory Committee (VRBPAC). The committee willvote on the agency's proposal. Currently, people who want to be fully vaccinated against COVID have to first get their primary vaccinations — two shots of the original vaccine spaced weeks apart. That's followed at least two months later by a booster, currently the bivalent shot that's tailored to protect against omicron. Under the new approach, most people would be advised to simply get whatever the latest version of the vaccine is annually each fall like the flu vaccine. They wouldn't have to worry about how many shots they've already gotten and which one they got when. Those who still need to receive two doses initially, such as young children and older people, would use the same formulation for all three shots. Vaccine makers would update the annual shot through a process that would begin each spring to try a match the vaccine as closely as possible to whatever variant will likely be dominant in the coming winter. That's how the flu vaccine is formulated each year. "FDA anticipates conducting an assessment of SARS-CoV-2 strains at least annually and to engage VRBPAC in about early June of each year regarding strain selection for the fall season," the FDA wrote in its briefing document, adding that updated vaccines would be readied for use by September each year. The agency notes that if a more dangerous COVID variant were to emerge, it might reconsider the vaccine strain at other times of the year on an "as-needed and emergent basis." Some immunologists and vaccine researchers say simplifying the process along the lines of the flu vaccine is appropriate at this point in the pandemic. However, many questions remain about emerging booster strategy. "As far as the tools that we have right now, I think it just makes the most sense to plan to update each year as close as we can to the currently circulating variant," says Deepta Bhattacharya, an immunologist at the University of Arizona. "So I think all the things the FDA is considering make a lot of sense." Questions about efficacy of updated shots There's an intense debate about the wisdom of updating the COVID vaccines regularly to try to match new variants. Some researchers question whether that really makes the vaccines more effective. They also argue the low demand for the latest booster shows the public has little appetite for continued boosting with the vaccines, even if they've been updated with new strains. "The public is voting with their arms if you will and said, 'No. I'm not going to get this. This doesn't make sense to us,'" says Dr. Gregory Poland, a vaccine researcher at the Mayo Clinic. While endorsing continued boosters for those at high risk, such as the elderly, some question whether the current bivalent vaccines updated to target omicron have enhanced protection compared to the original vaccines. Most people are still well-protected against severe disease by the immunity they already have, they say. "We have no solid dataabout the performance of the bivalent boosters," says John Moore, an immunologist at Weill Cornell Medical College. "The hard evidence is lacking, and the evidence that is out there is at the very least inconclusive and to me trends towards saying the bivalent boosters were little if no better." Moore and others argue the virus is changing so fast that it's pointless to constantly try to match the vaccines to the latest variants. "We shouldn't really be chasing these variants, which are evanescent and are often gone by the time you've created the vaccine," says Dr. Paul Offit of the University of Pennsylvania, one of the FDA's advisers. Offit and others also question whether everyone will necessarily need to be boosted regularly, or just those at high risk, like the elderly. Arguments for alternate vaccine strategies Critics of the FDA's proposed new strategy argue it would be better to invest in developing better vaccines that might be more appealing to people, and in campaigns to get more people vaccinated. Better vaccines could include those that could keep people from catching the virus in the first place not just from getting seriously ill — such as a nasal spray vaccine. Or perhaps vaccines that provide longer protection or are administered in pill form, to make them more acceptable to the needle-averse. "Particularly now when Congress is not allocating new funds for COVID response, we have to be especially judicious in how we spend our money and what would be most cost-effective," says Dr. Celine Gounder, a senior fellow at the Kaiser Family Foundation. "It's unclear whether updating the booster formulations and repeatedly boosting people is the most effective approach to controlling COVID at this stage." Another concern some researchers have is that the FDA continues to rely on antibody levels to test vaccine efficacy. "I think we need to raise the bar and require more evidence of clinical efficacy," says Dr. Eric Rubin, a professor of immunology and infectious diseases at Harvard who is also a member of the advisory committee. For instance, Rubin says the FDA should require proof the updated vaccines are actually reducing the risk of getting infected, getting sick, hospitalized and dying. Others say updating the vaccines make sense to make sure people are as well-protected as possible while researchers continue to try to develop new vaccines. "Even if you don't have a booster that matches 100% what's circulating, you will have a booster that matches 75% to 80% to 90% of what's circulating," says David Martinez, an immunologist at the University of North Carolina, Chapel Hill. "And that will be good enough. It would probably benefit most people." The FDA looks ahead to endemic COVID Some researchers think it's too soon to rely on annual boosters. COVID hasn't quite settled into a seasonal pattern like the flu, they note, and the SARS-CoV2 virus is changing more quickly than the flu virus. So people may need to be boosted more frequently, especially since protection against severe disease may only last about four to six months, they say. "We're going to be reaching that pretty soon with the early adopters of the bivalent boosters, like myself," says Dr. Peter Hotez, co-director of the Center for Vaccine Development at Texas Children's Hospital and dean of the National School of Tropical Medicine at Baylor College of Medicine. "I don't know if an annual strategy is going to cut it." The FDA's plan comes as COVID appears to be moving toward becoming an endemic disease. That doesn't mean it's going away or it's not a threat anymore. The disease will continue to be a threat for the foreseeable future, making many people sick and even potentially killing hundreds a day, making it a major public health problem and a leading cause of death, health experts say. But unless some more dangerous version of the virus suddenly emerges, the world might finally be settling into a more predictable co-existence with the virus. The federal official NPR spoke to says the goal of the new vaccine strategy is to make the vaccines, which are the major weapon for protecting ourselves, simpler and hopefully therefore more appealing. The latest boosters have found very few takers. The thinking is that at this point in the pandemic the overwhelming majority of people have a significant levels of immunity, either from having gotten vaccinated and boosted, or infected one of more times, or both. And while that immunity appears to protect most people from severe disease, that protection does appear to fade with time. The FDA is also considering making the shots interchangeable. That way people wouldn't have to worry which brand they're getting. Again, the change is aimed at making COVID shots more like the flu shots. People don't typically worry about the brand of the flu vaccine they receive. The vaccine would still be administered at different doses for different ages. And very young children and older people would still get two shots each year, much like the flu vaccine. If the FDA advisory committee endorses the approach Thursday, the FDA would work with the vaccine companies and Centers for Disease Control and Prevention to finalize the details. And the FDA advisers would meet again in the spring to pick the specific strain or strains of the virus the new shots should target.
The new bivalent booster is somewhat effective in stopping infection with XBB.1 and XBB.1.5; but not as effective as it was with BA.1 and BA.5. Covid Boosters Protect Against Latest Omicron Strains in Study https://www.bloomberg.com/news/arti...otect-against-latest-omicron-strains-in-study Study relieves some concern about immune-evasive mutants FDA advisers to discuss vaccine schedule, composition Thursday Updated Covid-19 boosters originally designed to protect against early omicron strains continued to reduce rates of illness from new mutants that have since spread rapidly throughout the US. The shots’ effectiveness against symptomatic infection ranged from 38% to 50% in recent months as the XBB and XBB.1.5 strains became dominant, Centers for Disease Control and Prevention scientists said Wednesday. The boosters helped most in adults from the ages of 18 to 49, according to a study in CDC’s Morbidity and Mortality Weekly Report.
Get the bivalent booster, avoid getting sick. Updated boosters are cutting the risk of getting sick from Covid-19 by about half https://www.cnn.com/2023/01/25/health/bivalent-boosters-covid-xbb-protection/index.html
As a follow-up -- after a complete investigation the FDA has not found an increased risk in strokes in those over 65 associated with the bivalent booster. FDA doesn’t see increased risk of stroke for seniors who received Pfizer’s omicron booster https://www.cnbc.com/2023/01/26/cov...-for-seniors-who-received-pfizer-booster.html The FDA has not identified a stroke risk in seniors who received the Pfizer booster after reviewing multiple federal databases. The FDA also reached out to regulators in Europe and Israel, who did not report an increased risk of stroke. Preliminary CDC data indicated a possible stroke risk following simultaneous administration of the Pfizer Covid booster and the flu vaccine. The Food and Drug Administration hasn’t found an increased risk of stroke for seniors who’ve received Pfizer’s omicron booster shot, a federal health official said Thursday. The FDA launched an extensive review of federal data after investigators at the Centers for Disease Control and Prevention detected a possible risk of stroke for seniors who received Pfizer’s booster. The CDC’s Vaccine Safety Datalink, which monitors serious reactions to vaccines, showed a possible risk of stroke in late November. The FDA independently looked at data from the Centers for Medicare and Medicaid Services and its Vaccine Adverse Event Reporting System. “So far the data that we have seen suggests the absence of a safety risk for the bivalent boosters in age 65 years and older,” Richard Forshee, deputy director of the FDA’s biostatistics office, told the agency’s independent vaccine committee. The FDA reviewed CMS data from 4.25 million seniors who received Pfizer’s omicron booster and did not identify any increased stroke risk. The agency’s review of VAERS data also did not find an increased risk. The Department of Veterans Affairs has also conducted preliminary review of its database and did not identify an increased stroke risk, Forshee said. The FDA also reached out to international partners and Pfizer to find out what they observed in their data. “We contacted a number of our international regulatory agencies, and various countries in Europe as well as Israel have indicated no increased risk of stroke on their surveillance systems,” Forshee told the FDA committee. “We also contacted Pfizer and they consulted their global safety database and they did not see any increase or a signal for ischemic stroke in their systems,” Forshee added. CDC investigators found that 130 seniors suffered strokes in the 21 days after receiving Pfizer’s booster among about 550,000 recipients in the VSD database. One man in his 70s died a month after the stroke which was his likely cause of death, according to data presented Thursday. Dr. Nicola Klein, the main investigator of the CDC’s Vaccine Safety Datalink, said a statistical signal indicating a potential stroke risk was first identified in late November and has persisted through January, though the signal’s strength has eased somewhat. “I will say that in the data from just a couple days ago it has attenuated substantially and actually has not signaled this past week for the first time,” Klein told the FDA panel of vaccine advisors. However, the investigators ran small analysis that indicated seniors who received both the Pfizer omicron booster and a high-dose or adjuvanted flu vaccine on the same day may have a higher risk of stroke, though the data is preliminary. Although the FDA has not identified a stroke risk, the agency is launching a study to examine potential safety concerns that may arise from administering the Covid omicron shots at the same time as the high-dose or adjuvant flu shots, Forshee said. The study will help the agency prepare for the vaccine campaign in the 2023-2024 respiratory virus season, he said.
This is the company which was manufacturing a plant-based Covid vaccine. With slowing demand for Covid vaccines and minimal market share plus WHO not accepting the Medicago vaccine for emergency use, the business is no longer viable. Quebec-based COVID-19 vaccine maker Medicago to shut down Owner Mitsubishi Chemical Group blames decision on 'significant changes' to vaccine market https://www.cbc.ca/news/canada/montreal/covid-vaccine-maker-medicago-shuts-down-1.6735521 Mitsubishi Chemical Group is shutting down Medicago Inc., a COVID-19 vaccine manufacturer with headquarters in Quebec City. A year ago, Medicago's plant-based COVID-19 vaccine, Covifenz, was approved by Health Canada, and it was touted as a homegrown shot against SARS-CoV-2. Then in March, the World Health Organization decided not to accept Medicago's COVID-19 vaccine for emergency use, citing the company's ties to big tobacco. Marlboro cigarette manufacturer Philip Morris International was once a shareholder of Medicago, but divested all of its shares in late 2022. Medicago Inc., which was founded in 1997, is now 100 per cent owned by Mitsubishi Tanabe Pharma Corporation. On Thursday, Medicago owner Mitsubishi Chemical Group issued a statement saying there have been "significant changes" to the vaccine market and, following a comprehensive analysis of the current global demand, the group decided to discontinue marketing Covifenz. "Furthermore, the group judged that it was not viable to continue to invest in the commercialization of Medicago's development products and therefore chose to terminate all its activities with Medicago and proceed with an orderly dissolution of its business affairs and activities," the statement said. According to the statement, Medicago's business activities and regular operating activities will be significantly reduced and refocused during the liquidation process. "Dissolution proceedings will take place in due course in accordance with local laws and regulations," it said. Government invested $173M in Medicago Canada's federal government invested $173 million into the company in 2020 to help the company develop the vaccine and its Quebec production facility. Ottawa also signed a deal to buy 20 million doses of the vaccine, with an option for 56 million more. The process developed by Medicago uses the plant species nicotiana benthamiana, a close relative of tobacco plants that is used for pharmaceutical development largely because of the high number of viruses that can successfully infect it. When it was approved, studies of Covifenz found the two-dose shot's overall efficacy rate against all virus variants studied was 71 per cent, with a higher efficacy rate of 75 per cent against COVID-19 infections from the delta variant. At the time, Health Canada said that "preliminary and exploratory data shows that Covifenz produces neutralizing antibodies against the Omicron variant." On Twitter Thursday, Quebec City Mayor Bruno Marchand called the Medicago closure a "huge pity." "My thoughts are with the families who learned some very sad news today," he said. "We have to roll up our sleeves to keep all this expertise in the field of health innovation in Quebec."
Mayor Eric Adams says COVID-19 vaccine to soon be optional for NYC workers https://abc7ny.com/covid-vaccine-nyc-mandate/12777104/ Most healthcare facilities had already begun using the "optional" vaccine choice several months before getting rid of vaccine mandates in 2023. Simply, ending a mandate when it was already optional in the fall of 2022 is just political gesturing after most healthcare workers had already made a choice to be fully vaccinated and many boosted. wrbtrader