Source: CNBC
KEY POINTS
- Pfizer CEO Albert Bourla said the drugmaker should have key data from its late-stage trial for the Food and Drug Administration by the end of October.
- If the FDA approves the vaccine, the company is prepared to distribute “hundreds of thousands of doses,” he said.
- On Saturday, Pfizer submitted a proposal to the FDA to expand the late-stage trial to include up to 44,000 participants, a significant increase from its previous target of 30,000.
Pfizer’s coronavirus vaccine could be distributed to Americans before the end of the year if found to be safe and effective, CEO Albert Bourla said Sunday.
The drugmaker should have key data from its late-stage trial for the Food and Drug Administration by the end of October, Bourla said during an interview on CBS’ “Face the Nation.” If the FDA approves the vaccine, the company is prepared to distribute “hundreds of thousands of doses,” he said.
Because of the pandemic, U.S. health officials and drugmakers have been accelerating the development of vaccine candidates by investing in multiple stages of research even though doing so could be for naught if the vaccine ends up not being effective or safe.
The U.S. pharmaceutical giant has been working alongside German drugmaker BioNTech. In July, the U.S. government announced it would pay the companies $1.95 billion to produce and deliver 100 million doses of their vaccine if it proves safe and effective. The deal was signed as part of Operation Warp Speed, the Trump administration’s effort to accelerate development and production of vaccines and treatments to fight the coronavirus.
Bourla said Sunday that the company has already invested $1.5 billion for the development of the potential vaccine. He said if the vaccine failed to work it would be financially “painful” for the company.
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In this day and age, understanding bacteria and viruses and developing vaccines are national security issues. In my view sizable part of every country’s defense budget should be spent in these pursuits rather than making tanks and other weapons.
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Categories: Vaccine
Pfizer chose not to take U.S. taxpayer money to help fund its coronavirus vaccine development, a move that CBS News’ Margaret Brennan pointed out on Sunday is a bit of a financial risk for the pharmaceutical giant.
CEO Albert Bourla admitted that it will indeed “be painful” if the vaccine fails, but “at the end of the day it’s only money” and the lack of taxpayer funds won’t “break our company.” It was more important for Bourla that his scientists were able to work without any strings attached, he said. “I wanted to liberate our scientists from any bureaucracy,” he continued. “When you get money from someone, that always comes with strings. They want to see how we are growing to progress, what types of moves you are going to do. They want reports. I didn’t want to have any of that.”
Bourla said he gave Pfizer’s team an “open checkbook” so they only have to worry about “scientific challenges.” Plus, he added, he wanted to keep Pfizer out of politics, a tall task for a pharma company on any day, but especially during this pandemic.
https://news.yahoo.com/pfizer-ceo-refused-taxpayer-money-175100171.html
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(Reuters) – Pfizer Inc PFE.N said on Tuesday participants were showing mostly mild-to-moderate side effects when given either the company’s experimental coronavirus vaccine or a placebo in an ongoing late-stage study.
The company said in a presentation to investors that side effects included fatigue, headache, chills and muscle pain. Some participants in the trial also developed fevers – including a few high fevers. The data is blinded, meaning Pfizer does not know which patients received the vaccine or a placebo.
Kathrin Jansen, Pfizer’s head of vaccine research and development, stressed that the independent data monitoring committee “has access to unblinded data so they would notify us if they have any safety concerns and have not done so to date.”
https://www.reuters.com/article/us-health-coronavirus-pfizer/pfizer-says-coronavirus-vaccine-study-shows-mostly-mild-to-moderate-side-effects-idUSKBN26631T