Arcturus announces 95% overall efficacy for mRNA-based COVID-19 shot https://seekingalpha.com/news/38246...ter-topline-data-for-mrna-based-covid-19-shot Disclosing topline data from an ongoing Phase 1/2/3 clinical trial, RNA medicines company, Arcturus Therapeutics (NASDAQ:ARCT) said on Wednesday that its self-amplifying mRNA vaccine ARCT-154 showed 95% overall efficacy in the prevention of severe COVID-19, including related deaths. However, the two-dose regimen of ARCT-154 at 5-mcg doses showed only 55% efficacy for preventing symptomatic COVID-19, according to the efficacy portion of the trial, which involved over 16,000 participants in Vietnam. Arcturus (ARCT) shares have lost ~9% in the pre-market so far. While there were nine COVID-19-related deaths in the placebo group, only one death was detected in the ARCT-154 arm. Based on safety data from over 17,000 participants, Arcturus (ARCT) said that there were no cases of myocarditis or pericarditis among trial subjects, and the occurrence of adverse events was comparable across both study arms. The study got underway when Delta and Omicron variants of coronavirus were dominant in Vietnam. “We are very pleased with these results, and to see ARCT-154 providing protection against symptomatic COVID-19 and almost complete protection against severe disease in a placebo-controlled vaccine efficacy study,” Chief Executive Joseph Payne noted. Read: Arcturus (ARCT) shares fell in January after the company reported booster data for the vaccine candidate.
Zero Covid is impossible.The Chinese are certainly up to something,you can be sure that it's not for the publicly given reasons. Could be that they are running an experiment to see how hard they can clamp down on people before they riot. Maybe the riots never occur.
Europe won’t have an Omicron-adapted mRNA vaccine until at least autumn https://fortune.com/2022/04/27/europe-omicron-vacccine-autumn/ Europe does not expect to have a vaccine tailored to fight off the Omicron variant until autumn at the earliest, officials in Brussels said on Wednesday. While China is busy combating its worst outbreak of COVID in months, Europe is relaxing its emergency measures and entering a new sustained phase, where it will try to flexibly manage the pandemic moving forward. Key to this is the development of a new mRNA vaccine that is more effective at boosting the immune system’s response to variants of Omicron, the dominant strain accounting for virtually all sequenced infections across the globe. “An authorization for an adapted vaccine I don’t think is expected before the end of the summer," said Stella Kyriakides, EU health and food safety commissioner told reporters during a briefing in Brussels. That is assuming companies continue to share information on a rolling basis and submit all the necessary data to the European Medicines Agency "in the coming months." Pfizer partner BioNTech, which developed the existing Comirnaty vaccine and delivered 2.6 billion doses last year, is currently working on an Omicron-adapted version. At the end of last month, it forecast the first data from clinical trials should be available in April. In December, the EU's 27 member states authorized thecommission, the bloc's executive arm, to purchase over 180 million further doses from Pfizer and BioNTech, which split the distribution rights. While not quantified, this consignment would include a potentially large number of vaccines developed specifically to target the new, highly contagious Omicron strain. Brussels will see to it that any such vaccine would be approved as quickly as possible, Kyriakides continued: "Once we have adapted vaccines, we will ensure that there is quick access and a sufficient quantity that we can make them available when necessary." According to the commissioner, an estimated 60% to 80% of the EU population have now had COVID at one point. While officials are no longer witnessing the same pressure on public health systems, the combination of restrictions being lifted alongside waning immunity and the high probability of new variants emerging means the pandemic has not disappeared. EU-wide booster campaigns are plateauing at about 64% of the adult population, and there are still 90 million Europeans unvaccinated. Moreover, potentially a tenth of those who are infected with the virus can still suffer effects months afterward due to long COVID. “Infections are still in the millions worldwide,” she said. “My message today to member states is a very clear one: We must not lower our guard.”
What are the numbers on that big nothingburger? China just pissin on the wheels of progress Supply-Chain-Wise. The China Kingpins feel no pain and usa sucks some more blue mud all with plausible deniablility and the ability to virtue signal to ignorang fools worldwide. Lock em down! weld em in! Rawhiiiiide! What a buncho Maroons.
Moderna seeks emergency use authorization for Covid-19 vaccine for children ages 6 months through 5 years https://www.cnn.com/2022/04/28/health/moderna-vaccine-eua-young-children/index.html Moderna is seeking emergency use authorization from the US Food and Drug Administration for its Covid-19 vaccine for children 6 months through 5 years of age, the company said Thursday. "We believe mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19, and will be especially welcomed by parents and caregivers," Stéphane Bancel, chief executive officer of Moderna, said in a news release. In late March, Moderna announced results of a clinical trial that included 2,500 children ages 6 months through 24 months and 4,200 children ages 2 through 5. The company said that two 25-microgram doses of its vaccine led to a similar immune response in young children as two 100-microgram doses for adults ages 18 to 25. And it said this should predict protection from Covid-19 and severe Covid-19 down to 6 months of age. In Thursday's news release, the company said the data showed "a robust neutralizing antibody response" and "a favorable safety profile." "We like to see anything above 1,000 units, and what we, in fact, saw here are levels somewhere between 1,400 and 1,800 units," Dr. Paul Burton, chief medical officer of Moderna, said Wednesday. "So that's extremely reassuring." Burton also said the vaccines were very safe for this age group. The most common reactions were pain at the injection site and fever. There were no cases of heart inflammation, or myocarditis, in the study. Heart inflammation has been an extremely rare side effect of the mRNA vaccines. Myocarditis is more common after Covid-19 infection than after vaccination. The results announced in March were mostly collected during the Omicron wave, and included home testing for Covid-19. As a result, the company said the vaccines looked less effective for children than they did for older age groups. The data presented by Moderna Thursday limited the analysis only to cases confirmed positive by sensitive reverse transcription-polymerase chain reaction tests. In the revised analysis, the vaccines were 51% effective at preventing symptoms in children ages 6 months to under 2 years; they were 37% effective at preventing symptoms in kids ages 2 through 5. The company said these efficacy estimates are similar to those among adults against Omicron after two doses. Pfizer/BioNTech's Covid-19 vaccine for young children has also stumbled. In clinical trials, two 3-microgram doses didn't appear to generate the same degree of immunity for children ages 2 through 4 as they had for young adults, prompting the company to look at giving children ages 6 months through 4 years a third dose. The FDA also delayed its review of these shots until the company submits data on a third dose. Boosters for younger children? On Tuesday, Pfizer asked the FDA to green-light a third or booster dose for children ages 5 through 11. Studies have shown that vaccine efficacy has waned significantly in this age group during Omicron. Burton said Wednesday that that Moderna was also testing boosters, including variant-specific formulations. "Our lead candidate now is something against the original strain and Omicron," he said, predicting that would be the booster formulation for the fall and winter. "And I think for these young kids, what we'll have to do is to continue to follow the natural history and see, what is the variant? What's going on with the little kids as we get into the fall? And then the FDA and CDC and regulators around the world can make recommendations on whether they need another booster later in the year." What's next for vaccines for younger children No Covid-19 vaccines have been authorized for children younger than 5 in the US -- about 18 million people. Moderna's mRNA Covid-19 vaccine is authorized for people 18 and older and Pfizer/BioNTech's for 5 and older. The FDA will evaluate Moderna's submission and has said it will convene its Vaccines and Related Biological Products Advisory Committee to weigh in on vaccine authorization for younger children. National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci has said that the FDA is weighing whether to consider emergency use authorization for both the Moderna and Pfizer/BioNTech Covid-19 vaccines for young children at the same time, rather than considering them separately. Pfizer has said the data on a third dose of the vaccine will be available this month. Pfizer CEO Albert Bourla said the vaccine for younger children could be available in June, If the FDA authorizes it.
The J&J Covid vaccine has a similar formula to the AstraZeneca vaccine -- and the exact same clotting problems. This news about the new FDA restrictions on the J&J vaccine are hardly surprising. All the proven medically-proven linked deaths in the U.S. to a Covid vaccine -- nine in total -- involve the J&J Covid vaccine. FDA puts strict limits on Johnson & Johnson Covid-19 vaccine https://www.cnn.com/2022/05/05/health/fda-johnson-johnson-vaccine-eua/index.html The US Food and Drug Administration announced Thursday that it is limiting the emergency use authorization of the Johnson & Johnson/Janssen Covid-19 vaccine to people 18 and older for whom other vaccines aren't appropriate or accessible and those who opt for J&J because they wouldn't otherwise get vaccinated. The FDA said in a statement that the change is being made because of the risk of a rare and dangerous clotting condition called thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine. The US Food and Drug Administration announced Thursday that it is limiting the emergency use authorization of the Johnson & Johnson/Janssen Covid-19 vaccine to people 18 and older for whom other vaccines aren't appropriate or accessible and those who opt for J&J because they wouldn't otherwise get vaccinated. The FDA said in a statement that the change is being made because of the risk of a rare and dangerous clotting condition called thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine. The FDA says it has determined that the benefits of the J&J vaccine outweigh the risks for certain people. Examples of people who may still get the vaccine include: Those who had a severe allergic reaction to an mRNA vaccine such as those from Pfizer/BioNTech or Moderna Those with personal concerns about the mRNA vaccines who would remain unvaccinated without the J&J vaccine Those with limited access to mRNA Covid-19 vaccines As of Thursday, more than 18.7 million doses of the J&J vaccine have been administered in the US, according to the US Centers for Disease Control and Prevention. Of those who are considered fully vaccinated, 7.7% got this vaccine. After a meeting in December, the CDC's vaccine advisory committee issued an updated recommendation on Johnson & Johnson's vaccine, saying it makes a "preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen adenoviral-vectored COVID-19 vaccine in all persons aged ≥18 years in the United States." The committee cited the same concerns over TTS. Both the CDC and the FDA previously recommended a pause in the use of this vaccine over reports of TTS. The pause was lifted, but that move came with a warning over the rare clotting events. Johnson & Johnson said in a statement at the time, "The safety and well-being of the people who use our products is our number one priority. We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. ... We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public." In an updated fact sheet on the vaccine, the FDA says that 15% of TTS cases have been fatal. The agency's updated analysis of the vaccine includes cases reported to its Vaccine Adverse Events Reporting System (VAERS) database through March 18. The FDA says it has confirmed 60 cases of TTS, including nine deaths. Overall, the risk of TTS is extremely rare: about three cases for every million doses of vaccine administered. The highest rate of TTS has been in women 30 to 49 years of age. About eight cases per 1 million doses of vaccine administered have been in women in this age group. Cases of TTS typically begin one or two weeks after vaccination. Symptoms include shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms like headaches or blurred vision, or red spots just under the skin called petechiae beyond the site of vaccination. The new warning on the vaccine's fact sheet says "The Janssen Covid-19 vaccine can cause thrombosis with thrombocytopenia syndrome (TTS) which may be life-threatening."