Moderna asking FDA to approve its virus vaccine

Half of them – or enough for 12.5 million people – are earmarked for the U.S.This week, a different panel of U.S. 10, Pfizer and BioNTech will present data suggesting their vaccine candidate is 95% effective. The only people who got severely ill – 30 participants, including one who died – had received dummy shots, said Dr. @US_FDA MUST ACT QUICKLY!!! But enough for the general population isn’t expected until at least spring.Outside the U.S., Zaks said significant supplies from Moderna would be available later, “in the first quarter” of next year.”Obviously we are doing everything in our power to increase the capacity and accelerate the timelines,” he said.Both Moderna’s and Pfizer’s vaccines are made with the same technology, using a piece of genetic code for the “spike” protein that studs the virus. Just imagine the impact then multiplied to the people who can get this vaccine.”Moderna said the shots’ effectiveness and a good safety record so far – with only temporary, flu-like side effects – mean they meet requirements set by the U.S. The AstraZeneca shots won’t require freezer storage like the Pfizer and Moderna vaccines. experts, established by the Centers for Disease Control and Prevention, will meet to decide how initial supplies will be given out. and Europe. Recipients will need two doses, so that’s enough for 10 million people.Pfizer expects to have 50 million doses globally in December. They’re expected to reserve scarce first doses for health care workers and, if the shots work well enough in the frail elderly, for residents of long-term care facilities. company, Novavax Inc., announced Monday that it has finished enrolling 15,000 people in a late-stage study in Britain and plans to begin recruiting even more volunteers for final testing in the U.S. study of the AstraZeneca candidate still is underway that should eventually give the FDA a better picture of how well it works. But because of a manufacturing error, a small number of volunteers got a lower first dose – and AstraZeneca said in that group, the vaccine appeared to be 90% effective.Experts say it’s unclear why the lower-dose approach would work better and that it may just be a statistical quirk.A larger U.S. and European regulators Monday to allow emergency use of its COVID-19 vaccine. in December. Trump (@realDonaldTrump) November 30, 2020

Moderna created its shots with the U.S. As more vaccine gradually becomes available in coming months, other essential workers and people at highest risk from the coronavirus would get in line. Governors to decide who gets vaccines first, health secretary says

U.S. Across the Atlantic, British regulators also are assessing the Pfizer shot and another from AstraZeneca. U.S. said it would ask U.S. 08:05

Moderna Inc. Since first emerging nearly a year ago in China, the virus has killed more than 1.4 million people worldwide.Moderna is just behind Pfizer and its German partner BioNTech in seeking to begin vaccinations in the U.S. hospitals have been stretched to the limit as the nation has seen more than 160,000 new cases per day and more than 1,400 daily deaths. and Mexico “in the coming weeks.”Vaccines made by three Chinese companies and a Russian candidate also are being tested in thousands of people in countries around the world. Rationing initial dosesIf the FDA allows emergency use, Moderna expects to have 20 million doses ready for the U.S. Moderna asking FDA and European regulators to approve its virus vaccine after trial “already saved lives”

November 30, 2020 / 10:58 AM
/ CBS/AP

COVID-19 vaccine breakthroughs: What happens now? Coronavirus: The Race To Respond

Will you get a stimulus check by December 31? “We have already, just in the trial, have already saved lives. Candidates made with still other technologies are in late-stage testing, too. The FDA has said any COVID-19 vaccine would have to be at least 50% effective.Meanwhile Britain’s government will have to decide whether its U.K. and several other countries to see if its vaccine candidate could work with just one dose.Both the J&J and AstraZeneca vaccines work by using harmless cold viruses to carry the spike protein gene into the body and prime the immune system.The different technologies have ramifications for how easily different vaccines could be distributed globally. government’s crash program to inoculate 300 million Americans against the coronavirus —  a “modern day miracle.”
Moderna now applying for Emergency Vaccine Approval.. COVID-19 vaccine breakthroughs: What happens … Moderna said its turn at this “science court” is expected exactly a week later, on Dec. Food and Drug Administration for emergency use before the final-stage testing is complete. data is sufficient for an early rollout there.Still in the pipelineJohnson & Johnson also is in final-stage testing in the U.S. by year’s end. “Operation Warp Speed has been a great modern day miracle.”— Donald J. The European Medicines Agency, Europe’s version of FDA, has signaled it also is open to faster, emergency clearance.What comes nextThe FDA has pledged that before it decides to roll out any COVID-19 vaccines, its scientific advisers will publicly debate whether there’s enough evidence behind each candidate.First up on Dec. National Institutes of Health and already had a hint they were working, but said it got the final needed results over the weekend that suggest the vaccine is more than 94% effective.Of 196 COVID-19 cases so far in its huge U.S. The request comes as new study results confirm the shots offer strong protection – ramping up the race to begin limited vaccinations as the coronavirus rampage worsens. 17. That messenger RNA, or mRNA, instructs the body to make some harmless spike protein, training immune cells to recognize it if the real virus eventually comes along.AstraZeneca confusionAstraZeneca last week announced confusing early results of its vaccine candidate from research in Britain and Brazil

That vaccine appears 62% effective when tested as originally intended, with recipients given two full doses. First published on November 30, 2020 / 7:25 AM Multiple vaccine candidates must succeed for the world to stamp out the pandemic, which has been on the upswing in the U.S. Get Breaking News Delivered to Your Inbox

President Donald Trump reacted to Moderna’s news on Twitter Monday morning, calling Operation Warp Speed — the U.S. Tal Zaks, the Cambridge, Massachusetts, company’s chief medical officer. study, 185 were trial participants who received the placebo and 11 who got the real vaccine. had more COVID cases this month than most countries had all year

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When he learned the results, “I allowed myself to cry for the first time,” Zaks told The Associated Press. Another U.S.