Moderna's Covid-19 vaccine receives full FDA approval https://www.cnn.com/2022/01/31/health/moderna-covid-vaccine-fda-approval/index.html
Pfizer-BioNTech coronavirus vaccine for children under 5 could be available by the end of February, people with knowledge say Coronavirus vaccines for children younger than 5 could be available far sooner than expected — perhaps by the end of February — under a plan that would lead to the potential authorization of a two-shot regimen in the coming weeks, people briefed on the situation said Monday.
The reality is that Novavax is trying to get regulatory approval in the U.S. so other countries will accept their Covid vaccine. As outlined previously they expect to distribute very few doses in the U.S. and their business plan is built around providing low-cost doses internationally -- with the hope that western countries will pay for the doses to be distributed or donated across the globe. Novavax could offer unvaccinated Americans a new option, if regulators agree https://www.cbsnews.com/news/covid-vaccine-novavax-seeking-fda-authorization/ Following a long-awaited submission of data to the Food and Drug Administration last month, Novavax announced Monday that it had formally filed a request for emergency use authorization of its protein-based COVID-19 vaccine in the United States. If greenlighted by the FDA, Novavax's shots could be the first COVID-19 doses available in the U.S. based on a kind of "protein subunit" technology that has been used for decades in other routine vaccinations. Officials say having this option could help persuade some remaining vaccine holdouts to get the shots, as well as boost the Biden administration's international vaccine donation goals. "We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic," Novavax's president and CEO Stanley Erck said in a statement announcing the submission. Novavax's vaccine would be for people aged 18 and over. But the share of American adults left to vaccinate is shrinking. Close to 90% of U.S. adults already have at least one dose of COVID-19 vaccine, according to the Centers for Disease Control and Prevention. The vast majority were vaccinated with the mRNA-based vaccines developed by Moderna or Pfizer and BioNTech, which have proven safe and effective at curbing COVID-19 cases and deaths in millions of Americans. However, federal health officials have long said that protein-based vaccines might still have a path to authorization, in the hopes of persuading holdouts unwilling or unable to receive the mRNA shots. "There are some people in the United States who still will not take our mRNA vaccines and they are waiting for a protein-based vaccine. And for us, anything we can do to help get a larger portion of our population vaccinated is something that we need to do," Dr. Peter Marks, the FDA's top vaccines official, said at a conference last year. A spokesperson did not comment on whether the FDA would convene a meeting of its outside vaccine experts, the Vaccines and Related Biological Products Advisory Committee, before deciding whether to authorize Novavax's shots, as it did for the Pfizer-BioNTech, Moderna, and Johnson & Johnson vaccines. Both the FDA and the Centers for Disease Control and Prevention must sign off on Novavax's COVID-19 vaccine before the first doses can be rolled out. Of the portfolio of vaccines whose development was backed by the Trump administration's Operation Warp Speed early in the pandemic, two — Novavax's shots as well as another developed by Sanofi Pasteur and GlaxoSmithKline — are protein-based. Unlike traditional vaccines, which rely on injecting a dose of the entire disabled or weakened virus, scientists developing protein subunit vaccines pick out only specific fragments of the virus to trigger an immune response. The technique has been used for years in vaccines against hepatitis B, pertussis (whooping cough) and other diseases. Protein vaccines like Novavax's doses are also combined with ingredients called adjuvants that can stimulate the body to train a better immune response. This is different from the mRNA vaccines or Johnson & Johnson's Janssen "viral vector" vaccine, which work by getting some of the body's cells to produce a harmless portion of SARS-CoV-2, the virus that causes COVID-19, in order to trigger an immune response. Novavax's shot has already won regulatory approvals in several countries around the world, including Australia and South Korea this month. The vaccine has also been greenlighted by the World Health Organization, manufactured by sites in Europe and India. The company has touted results showing the vaccine was safe and effective at curbing infections — around 90% overall — in published findings of clinical trials of its doses in North America and the United Kingdom earlier in the pandemic. Novavax also says its vaccine should work against the Omicron variant, citing data from booster and adolescent studies. However, the company's submission comes later than initially hoped for. Last May, Novavax told investors it expected to file for the FDA's authorization "in the third quarter of 2021." Over the summer, the company disclosed the Biden administration had paused funding for Novavax's manufacturing until it could strike an agreement with the FDA over "analytic methods" for its vaccine. The company completed submitting its final data on its manufacturing efforts to the FDA at the end of December. Beyond its potential use in vaccinating Americans, State Department officials say they have pushed for scaling up Novavax's production in hopes of meeting goals for vaccine donations abroad. "Novavax is another big, big variable at this point, and I think if Novavax comes through fairly soon, that will be wonderful and that will be a big help because they're a major part of the COVAX portfolio," Jeremy Konyndyk, head of the U.S. Agency for International Development's COVID-19 task force, told reporters in October.
Germany: Vaccine advisory panel backs Novavax COVID jab Germany's expert panel on vaccine use (the StiKo) recommends the protein-based jab as a first vaccination for adults, but says booster shots should be mRNA vaccines. https://www.dw.com/en/germany-vaccine-advisory-panel-backs-novavax-covid-jab/a-60642481
COVID digest: EU medical watchdog open to omicron-specific vaccines The European Medicines Agency has said it would support vaccines that specifically target the omicron variant. https://www.dw.com/en/covid-digest-...GK_RSS_SmartNews_Volltext_ENG-20051-xml-media
S Africa’s Afrigen makes mRNA COVID vaccine using Moderna data The vaccine candidate is the first mRNA vaccine designed, developed and produced at lab scale on the African continent. https://www.aljazeera.com/news/2022...n-makes-mrna-covid-vaccine-using-moderna-data South Africa’s Afrigen Biologics has used the publicly available sequence of Moderna’s COVID-19 mRNA vaccine to make its own version of the shot, which could be tested in humans before the end of this year, Afrigen’s top executive said on Thursday. The vaccine candidate would be the first to be made based on a widely used vaccine without the assistance and approval of the developer. It is also the first mRNA vaccine designed, developed and produced at lab scale on the African continent. The World Health Organization (WHO) last year picked a consortium, including Afrigen, for a pilot project to give poor and middle-income countries the know-how to make COVID-19 vaccines, after market leaders of the mRNA COVID vaccine, Pfizer, BioNTech and Moderna, declined a WHO request to share their technology and expertise. The WHO and partners hope the hub will help overcome glaring inequalities between rich nations and poorer countries in accessing vaccine doses, with 99 percent of all of Africa’s vaccines imported and the negligible remainder manufactured locally. During the pandemic, wealthy countries have hoovered up most of the world’s supplies of vaccines. Biovac, a partly state-owned South African vaccine producer, will be the first recipient of the technology from the hub. Afrigen has also agreed to help train companies in Argentina and Brazil. In September, the WHO’s hub in Cape Town decided to go it alone after failing to bring on board Pfizer and Moderna, both of which have argued they need to oversee any technology transfer due to the complexity of the manufacturing process. Moderna’s vaccine was chosen due to an abundance of public information and its pledge not to enforce patents during the pandemic. It’s not clear what will happen after that. The UN-backed Medicines Patent Pool (MPP) said it was in talks with Moderna about possible access to some of its patents Under pressure to make drugs in lower-income countries, Moderna has announced plans to build mRNA vaccine factories in Africa, but production is still a long way off. Biovac has agreed to fill and finish the Pfizer-BioNTech vaccine, the final stages of production, although the drug substance will come from Europe. “We haven’t copied Moderna, we’ve developed our own processes because Moderna didn’t give us any technology,” Petro Terblanche, managing director at Afrigen told Reuters. “We started with the Moderna sequence because that gives, in our view, the best starting material. But this is not Moderna’s vaccine, it is the Afrigen mRNA hub vaccine,” Terblanche said. She said it had managed to make, in collaboration with Johannesburg’s University of the Witwatersrand, its first micro-litre laboratory-scale batches of COVID-19 mRNA vaccines at the Cape Town facility. Terblanche said it was working on a next-generation mRNA vaccine that did not need freezing temperatures for storage, which are required for the Pfizer and Moderna doses, and which would be better suited to the hot conditions of Africa with its poor health facilities and infrastructure. Afrigen was recruiting staff and receiving training from international partners including Thermo Fisher Scientific, she said. “We will only make our clinical trial batch probably in six months from now, [meaning] … fit for humans. And the target is November 2022,” Terblanche added. Online training for other companies to make the shot started with manufacturers in Brazil and Argentina last year. Afrigen expected to get more on board within the next month.
New High for Vaccine Failure; Freedom Convoy Goes Global; Unrest at HHS; Countries Roll Back Restrictions; Cancel Culture Cancels Self over Joe Rogan; Economic Forecaster Predicts End of Nations Guest: Martin Armstrong Episode 253: CANCELING COVID minute 2:15 https://www.bitchute.com/video/NCH2FRyUXYrB/
Ah, Bitchute -- along with Rumble -- the home of absurd anti-vax Covid misinformation. Remember to watch all the white supremacist and neo-nazi videos as well while perusing these sites.