Less than a year after the unprecedented effort began, the first COVID-19 vaccines are expected to reach Americans within weeks. No one knows when for certain, but Dec 13 is the first possible day the vaccine could be administered. The week after however is most likely.
Alex Azar talked about this situation on FOX Business "Mornings with Maria"
Alex Michael Azar Jr. is an American politician, attorney and former pharmaceutical executive who serves as the United States Secretary of Health and Human Services.
"At this point, it is really a matter of working out some final details," he said. "Within the next couple of days, it ought to come out and we'll start having Pfizer ship that vaccine to where governors have told us."
The Trump administration has been negotiating with five other pharmaceutical companies and six manufacturers for an estimated 800 million COVID-19 vaccine doses, Azar said, adding that Johnson & Johnson and AstraZeneca may start distributing a vaccine as soon as January.
Developing a vaccine for disease, which reached pandemic proportions after it was identified in identified in Wuhan, China, has been a "top priority" for the Trump administration through its "Operation Warp Speed."
However is he being honest?
Finding “a safe and effective vaccine” to prevent infection from the new coronavirus “is an urgent public health priority,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a statement Monday. “This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.”
The National Institutes of Health, an agency within the Department of Health and Human Services, has been fast-tracking work with biotech company Moderna to develop a vaccine using the genetic sequence of the new coronavirus. The trial is taking place at the Kaiser Permanente Washington Health Research Institute in Seattle, Washington, where COVID-19 cases have surged and authorities have banned mass gatherings. The early-stage, or phase 1, trial will test the vaccine on 45 males and non-pregnant females between the ages of 18 and 55, according to trial details on NIH’s website.
There are no proven therapies for the latest outbreak, which has killed at least 6,513 and sickened nearly 170,000 people worldwide since emerging from the Chinese city of Wuhan less than three months ago.
Pfizer and its German collaborator BioNTech applied for emergency use authorisation for their COVID-19 vaccine from the Food and Drug Administration.
Moderna is expected to send in its application for its vaccine one to two weeks later, perhaps by Dec. 4.
The early-stage trial will be led by Dr. Lisa Jackson, a senior investigator at Kaiser. Study participants will receive two doses of the vaccine via intramuscular injection in the upper arm approximately 28 days apart, NIH said. Each participant will be assigned to receive a 25 microgram, 100 mcg or 250 mcg dose at both vaccinations, with 15 people in each dose cohort, the agency said.
“This work is critical to national efforts to respond to the threat of this emerging virus,” Jackson said. “We are prepared to conduct this important trial because of our experience as an NIH clinical trials centre since 2007.”
Fauci told reporters last week a vaccine for public use likely won’t be ready for another 12 to 18 months.
He said the potential vaccine by Moderna contains genetic material called messenger RNA, or mRNA, that was produced in a lab. The mRNA is a genetic code that tells cells how to make a protein and was found in the outer coat of the new coronavirus, according to researchers at the Kaiser Permanente Washington Health Research Institute.
The mRNA instructs the body’s own cellular mechanisms for making proteins to make those that mimic the virus proteins, thereby producing an immune response.
An emergency use authorisation is a fast track vaccine authorisation that can be processed much more quickly than the usual Biologics License Application, which results in FDA licensing a drug or vaccine.
The FDA is expected to take one to three weeks to go through the application and make a decision on issuing the emergency authorisation.
"It's typically months, occasionally weeks," said Dr. Greg Poland, director of the Mayo Clinic's Vaccine Research Group.
In theory the final vote will come from the Centre for Disease Control and Prevention's Advisory Committee on Immunisation Practices. The ACIP makes the official decision on who should get the vaccine and in what order.
In October, the National Academies of Sciences, Engineering, and Medicine outlined a plan for fair distribution that's being used as a framework by the CDC committee, but ACIP has the final say.
ACIP isn't allowed to make a recommendation before a vaccine has been authorised or approved. Typically, this would happen within weeks of FDA's action. But in this case, several members have suggested such a meeting could take place the day after the vaccine is authorised.
The earliest such a meeting could happen would be Dec. 12. Once it votes, the ACIP submits a decision memo to the CDC director for approval. Once approved, immunisations can begin.
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