On Monday, biotech company Moderna applied for an emergency permit for a coronavirus vaccine, capping a scientific race that began in January. Moderna's two-dose regimen is about a week later than a similar vaccine developed by Pfizer and the German biotechnology company BioNTech.
The federal government could begin distributing two coronavirus vaccines in the next few weeks - a record-breaking achievement that now hinges on US regulatory decisions.
Biotech company Moderna, on Monday, applied for an emergency permit for a coronavirus vaccine, capping a scientific race that began in January. Moderna's two-dose regimen is about a week later than a similar vaccine developed by Pfizer and the German biotechnology company BioNTech.
No vaccine can arrive soon enough to quell an expected attack of coronavirus cases categorized by Thanksgiving trips and gatherings - and an increase is expected in the coming days and weeks.
But less than a year after a new virus began to spread around the world, US government officials are expecting an unprecedented scientific breakthrough: About 40 million doses of two significantly effective vaccines could be available by the end of the year, which is enough for 20 million people to receive full protection. .
Manufacturing will continue to increase until early next year, and other vaccines are expected to follow to steadily increase available supplies every month.
The news comes as health systems are approaching a potential crisis with daily infections and hospitalizations escalating leading to Christmas and the New Year.
The Association of American Medical Colleges on Monday called on medical schools, teaching hospitals and health systems in the country to prepare to implement crisis standards over the next few months in the event that screening and rationing are necessary due to a shortage of health care workers and hospitals, beds or supplies. It has been used to respond to natural disasters and mass casualty events such as the September 11 terrorist attacks.
"The next few months of the pandemic, while we wait for vaccines to be distributed, will work to expand the nation's healthcare capacity to its limits," said Group President and CEO David Skorton.
California Gov. Gavin Newsom, a Democrat, said on Monday that he is considering imposing stay-at-home orders in California counties to curb the explosion of coronavirus cases that threaten to flood hospitals by Christmas.
Before Thanksgiving weekend, the United States had reached a daily coronavirus death toll not seen since May, with more than 2,000 people dying from Tuesday to Wednesday. Case numbers over the weekends and holidays tend to reflect delays in testing and reporting, but the number of cases in hospital has continued to rise, surpassing 95,000 patients with COVID-19 for the first time on Monday.
Reflecting the urgency of the situation in the United States, the Centers for Disease Control and Prevention advisory committee, which usually meets after vaccines are approved, holds an extraordinary emergency virtual meeting on Tuesday to vote on which groups of people should get the first limited meeting. Shots.
Health care workers and residents of long-term care facilities are expected to be included in the first case, a strategy aimed at ensuring that the first doses have the greatest societal impact. But even if manufacturing schedules are on track, there will not be a completely sufficient vaccine for everyone in these groups to be fully vaccinated by the end of the year.
"Getting healthcare workers a priority is ... keeping our health care system functioning and protecting them," said Natalie Dean, a biostatistician at the University of Florida.
The regulatory approval process will move to its highest level on Thursday, when independent FDA advisors meet to make recommendations for a Pfizer and BioNTech vaccine. A week later, they'll do the same with Moderna.
The Food and Drug Administration is conducting a comprehensive review to check the safety, efficacy, and manufacture of vaccines, and is expected to make a decision shortly after its advisors meet. The review period, from the company's submission to the decision, will likely take weeks - not the most popular year after the company submits a vaccine for approval.
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