Modern COVID-19 vaccine ready for USA Greenlight after FDA advisory panel endorsement

WASHINGTON – A government advisory panel on Thursday endorsed a second COVID-19 vaccine, paving the way for the shot to be included in the US vaccination campaign.

The Food and Drug Administration is expected to recommend the vaccine from the Modern and National Institutes of Health and to heal quickly. FDA advisors, in a 20–0 vote, agreed the benefits of the vaccine to those 18 years and older were at risk.

Once the right to emergency use is granted, modern, millions of doses will begin shipping to health workers and nursing home residents to promote the largest vaccination efforts in US history.

The campaign earlier this week developed the first vaccine in the US with OK’d developed by Pfizer and BioNTech. Modern’s shot showed equally strong effectiveness, providing 94% protection against COVID-19 in an ongoing study of the company’s 30,000 people.

After a seven-hour debate on the technical details of the company’s study and follow-up plans, nearly all panelists supported making the vaccine available to fight the epidemic. A panel member was stopped.

Dr. of Stanford University Medical Center. Hayley Gans said, “Any of the evidence that has been studied in detail on this vaccine gets a lot of attention.”

A second vaccine is urgently needed due to coronovirus infection, hospitalization, and going to a new height before the holidays. With more than 1.6 million confirmed cases and more than 310,000 deaths, America leads the world in virus totals.

Modern’s vaccine uses the same groundbreaking technology that Pfizer-BioNotech shot. Most traditional vaccines use dead or weakened viruses, but both new vaccines use snippets of the genetic code of COVID-19 to train the immune system to detect and fight the virus. Both require two doses; Modern is four weeks apart.

University of Michigan Dr. Arnold Monto said “two new vaccines will hopefully” help break the back of the epidemic.

Thursday’s review comes days after two Alaska health workers reported apparent allergic reactions to the Pfizer-BioNotech vaccine. One person had a severe reaction, including shortness of breath, the other had less serious side effects, including a lighthouse.

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While the two vaccines use the same technology, they are modern, Chief Medical Officer Drs. Rhythms are not the same as Zax. In particular, some lipids or fats used to coat the two vaccines differ.

“I wouldn’t necessarily agree” that any response would be similar, he said.

The FDA found no serious allergies in Modern’s data, but did characterize slightly higher rates of less severe side effects – rash, hives, itching – in participants who received a dummy shot compared to those who received the vaccine.

Bell also had three cases of paralysis, which temporarily paralyze the facial muscles, compared to just one in those receiving vaccines, dummy shots. The FDA review stated that the pill’s role in the vaccine group “cannot be ruled out.”

An unanswered question is whether the vaccine also protects people from asymptomatic infection – but Modern indicated that it may. Study participants had their nose swollen before the second dose of vaccine or placebo. Dr. of Modern Jacqueline Miller stated that at one point in time, inflammation from 14 vaccine recipients and 38 placebo recipients showed evidence of asymptomatic infection.

Modern is only starting to study its vaccine in 12 to 17 year olds. Testing in young children is expected to begin early next year.

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Following FDA acts, US authorities plan to transfer initial shipments of approximately 6 million modern doses. The vaccine needs to be stored at a regular freezer temperature, but not the ultra-cold required for Pfizer-BioNotech shots.

With Modern’s vaccine, government officials say 20 million Americans will be able to get their first shots by the end of December and 30 million more in January.

The general public will eventually require hundreds of millions of additional shots to vaccinate, which is not expected until spring or summer. The government’s Operation Tana Gati program orders 200 million doses of Modern’s vaccine. This is on top of 100 million doses of the Pfizer-BioNTech vaccine. Officials are negotiating to buy more doses of that vaccine and more vaccines are in the pipeline.

Like the first vaccine, the use of Modern will continue to be practical as the company has to continue the study for two years, answering the key questions, including how long security is involved.

One of the trickier issues was the panelists debating how to keep study volunteers who got dummy shots from draping to take real shots. Their involvement is important for comparing long-term safety and effectiveness.

Adhunik immediately proposes to alert all those volunteers about their situation and offer them the vaccine. The company said that more than 25% of its participants are health workers and some are already quitting receiving the Pfizer vaccine.

But Stanford University invited expert Drs. Steven Goodman suggested Moderna adopt Pfizer’s approach. That company plans to gradually vaccinate people in its placebo group when they usually had access to the vaccine, such as priority groups that are established.

But most panellists acknowledged that if they wanted to wait to take a shot, it would be difficult to prevent volunteers from leaving the Modern Study.

Dr. of Seattle Cancer Care Alliance “The reality can be a lot more difficult than this,” said Steven Pergam.

Exactly how treating trial participants who received dummy shots is important beyond ethics: Modern noted that the only COVID-19 out of 30,000 volunteers died in a 54-year-old man, a placebo recipient, whose only risk factor was diabetes. Was.

Miller of Moderna said that knowing that those receiving placebo may have more severe coronaviruses “weighs on me modernly.”

Copyright © 2020 by The Associated Press. All rights reserved.


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