Next stop for covid-19 vaccines: FDA review

Pfizer and BioNTech to submit request for emergency use approval of their COVID-19 vaccine today		
		
	Darrell Etherington

			@etherington	 
		9 hours

Pfizer and BioNTech said they expect to manufacture up to 50 million doses globally this year, with about half of the doses going to the USA -or enough to vaccinate 12.5 million Americans with the two-shot regimen.

"A first in the history of mankind: less than a year from the sequence of the virus to the large-scale clinical trial of a vaccine, moreover based on a whole new technique", Enrico Bucci, a biologist at Temple University in Philadelphia, was quoted by the agency.

The Union health ministry had also said on Tuesday that the cold-chain requirements of Pfizer's coronavirus vaccine posed a big challenge to India's mass-vaccination campaign, but the government is examining all possibilities for its procurement.

Both the Pfizer/BioNTech and Moderna vaccines work using a new technology to trigger an immune response known as synthetic messenger RNA that can be produced at scale much more quickly than traditional vaccines. The Pfizer and BionTech vaccine went into tests shortly thereafter.

There are still many questions to be answered, including how long vaccination protection will last and how they will respond to regulators' scrutiny.

Less than two weeks after releasing an interim data analysis, pharmaceutical companies Pfizer and BioNTech have announced their massive global Phase 3 vaccine trial is complete.

Pfizer's vaccine must be shipped and stored at freezing temperatures of -70 degrees Celsius from the moment they are bottled to the time they are ready to be injected.

Of dozens of drugmakers and research institutions racing to develop COVID-19 vaccines, the next late-stage data is expected to come from AstraZeneca Plc, which is working with the University of Oxford, in November or December. The panel will likely be asked to recommend whether the vaccine should be authorized for use and in which populations.

A large part of what made progress possible was money. And while Pfizer did not take funds for development, it benefited from the huge supply of the United States and other countries that guarantee a market if vaccines are approved. The rest of the cases were in the placebo group given a dummy jab.

"We can expect both agencies to conduct a very careful evaluation and we can rely on their conclusions", he said.

Global drugmakers Pfizer and BioNTech said on Wednesday that their COVID-19 vaccine was found 95% effective in the final analysis of the Phase 3 trial, including in people aged over 65 years, paving the way for the companies to apply for emergency authorisation from USA regulators within days.

"I think that's a pretty good window to see a bad side effect like Guillain-Barré", said Dr. A measure that the government has always wanted to avoid, but faced with the rapid and risky rise of the second wave of Covid-19 - more than 5,000 positive cases per day - the French president had to resolve himself and declare a new quarantine. Moderna shares fell 3.6 percent.

This is the first coronavirus vaccine to seek a regulatory OK in the United States.

Batalvi rolled up for a second dose, not knowing if it would be the vaccine or a placebo, last week. Older adults tended to report fewer and milder adverse events.

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