New Delhi: The US Food and Drug Administration (FDA) is likely to approve Pfizer-BioNtech’s two-dose COVID-19 vaccine on Monday, The New York Times reported, citing “people familiar with the agency’s plan”.
While there has yet to be an official statement from the FDA on this, the NYT report said that regulators were still working through “a substantial amount of paperwork and negotiations with the company.”
The approval will accelerate the earlier timeline set for licensing the shot.
Read also | explained | It rained for the first time at the Greenland summit. Know why this is a cause for concern
The report, quoting sources familiar with the matter, said approvals may take longer if certain components of the review are not completed before Monday.
The FDA recently set an unofficial deadline for approval, saying it could come around Labor Day, which is Sept. 6.
The report said that once full approval is granted, the drugmaker plans to ask the FDA to approve a third dose of the COVID vaccine as a booster shot.
The Joe Biden administration has already announced that fully vaccinated adults should be ready to get booster shots eight months after the second dose, starting September 20.
Pfizer has said a third shot is safe and effective against infection, and is likely to submit data next week to substantiate its claim.
Regulators are still reviewing the application for full approval for Moderna’s vaccine. Moderna plans to submit its data in support of the booster shot in September.
The Pfizer vaccine is not currently in use in India. According to reports, the Narendra Modi government is not inclined to compensate Pfizer or any other foreign drugmakers against liabilities if the recipients of their vaccines develop serious adverse reactions.
Earlier this year, Pfizer withdrew its application with the regulatory authority in India after the government did not relent on its demand for damages.
However, citing a company spokesperson, the Wall Street Journal reported earlier this month that India is in talks to buy 50 million doses of Pfizer-BioNtech vaccine.
What is full license and how is it different from EUA?
Pfizer-BioNtech currently has an emergency use authorization, or EUA, which the FDA grants during the crisis to give people quick access to potentially life-saving drugs. This was the first time new vaccines were given to the EUA during the Covid pandemic.
Formerly, EUAs were typically used for drugs during “very devastating, urgent situations, such as an anthrax attack,” according to former FDA chief scientist Jesse Goodman, who is now with Georgetown University.
This is the scale that makes all the difference between an EUA and a full approval.
Goodman told Science magazine that full approval is a “thorough review.”
The FDA reviews a lot of data, which takes a long time before a vaccine or drug is given full approval.
For full approval, the FDA analyzes additional clinical trial data, and also studies real-world data on the effectiveness of the vaccine or drug and safety. It also inspects manufacturing facilities to check quality control standards.
“It’s not a huge difference, but it is a real difference,” Goodman said.
The FDA accepted Pfizer’s application for full approval “under priority review” on July 16 of this year.
What does full approval for vaccines mean?
Full acceptance of the Pfizer vaccine could pave the way for multiple vaccination requirements by public and private organizations as they waited before making vaccination mandatory.
A large number of universities and high-profile hospitals in the US have already mandated that staff and students be vaccinated, but there are many organizations that are hesitant to do so because vaccines are still awaiting full approval. Is.
US officials also believe that full approval will also help fight hesitation as many Americans are reluctant to take a vaccine that was authorized for emergency use only, a recent survey suggested. Was.
Eric Topol, director of the Scripps Research Translational Institute, wrote in an op-ed, “Some people who understand that the ‘e’ in ‘EUA’ stands for ’emergency’ wait for full FDA approval before getting a shot.” are doing.” NYT in July
A survey of nearly 2,000 adults conducted in June by the Kaiser Family Foundation found that about 30 percent of unvaccinated people were waiting for vaccines to be fully approved.
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explained | The Pfizer COVID Vaccine Could Get FDA’s ‘Full Approval’ By Monday. What does it mean
New Delhi: The US Food and Drug Administration (FDA) is likely to approve Pfizer-BioNtech’s two-dose COVID-19 vaccine on Monday, The New York Times reported, citing “people familiar with the agency’s plan”.
While there has yet to be an official statement from the FDA on this, the NYT report said that regulators were still working through “a substantial amount of paperwork and negotiations with the company.”
The approval will accelerate the earlier timeline set for licensing the shot.
Read also | explained | It rained for the first time at the Greenland summit. Know why this is a cause for concern
The report, quoting sources familiar with the matter, said approvals may take longer if certain components of the review are not completed before Monday.
The FDA recently set an unofficial deadline for approval, saying it could come around Labor Day, which is Sept. 6.
The report said that once full approval is granted, the drugmaker plans to ask the FDA to approve a third dose of the COVID vaccine as a booster shot.
The Joe Biden administration has already announced that fully vaccinated adults should be ready to get booster shots eight months after the second dose, starting September 20.
Pfizer has said a third shot is safe and effective against infection, and is likely to submit data next week to substantiate its claim.
Regulators are still reviewing the application for full approval for Moderna’s vaccine. Moderna plans to submit its data in support of the booster shot in September.
The Pfizer vaccine is not currently in use in India. According to reports, the Narendra Modi government is not inclined to compensate Pfizer or any other foreign drugmakers against liabilities if the recipients of their vaccines develop serious adverse reactions.
Earlier this year, Pfizer withdrew its application with the regulatory authority in India after the government did not relent on its demand for damages.
However, citing a company spokesperson, the Wall Street Journal reported earlier this month that India is in talks to buy 50 million doses of Pfizer-BioNtech vaccine.
What is full license and how is it different from EUA?
Pfizer-BioNtech currently has an emergency use authorization, or EUA, which the FDA grants during the crisis to give people quick access to potentially life-saving drugs. This was the first time new vaccines were given to the EUA during the Covid pandemic.
Formerly, EUAs were typically used for drugs during “very devastating, urgent situations, such as an anthrax attack,” according to former FDA chief scientist Jesse Goodman, who is now with Georgetown University.
This is the scale that makes all the difference between an EUA and a full approval.
Goodman told Science magazine that full approval is a “thorough review.”
The FDA reviews a lot of data, which takes a long time before a vaccine or drug is given full approval.
For full approval, the FDA analyzes additional clinical trial data, and also studies real-world data on the effectiveness of the vaccine or drug and safety. It also inspects manufacturing facilities to check quality control standards.
“It’s not a huge difference, but it is a real difference,” Goodman said.
The FDA accepted Pfizer’s application for full approval “under priority review” on July 16 of this year.
What does full approval for vaccines mean?
Full acceptance of the Pfizer vaccine could pave the way for multiple vaccination requirements by public and private organizations as they waited before making vaccination mandatory.
A large number of universities and high-profile hospitals in the US have already mandated that staff and students be vaccinated, but there are many organizations that are hesitant to do so because vaccines are still awaiting full approval. Is.
US officials also believe that full approval will also help fight hesitation as many Americans are reluctant to take a vaccine that was authorized for emergency use only, a recent survey suggested. Was.
Eric Topol, director of the Scripps Research Translational Institute, wrote in an op-ed, “Some people who understand that the ‘e’ in ‘EUA’ stands for ’emergency’ wait for full FDA approval before getting a shot.” are doing.” NYT in July
A survey of nearly 2,000 adults conducted in June by the Kaiser Family Foundation found that about 30 percent of unvaccinated people were waiting for vaccines to be fully approved.
See below health equipment-
Calculate your body mass index (BMI)
Calculate Age Through Age Calculator
.