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Coronavirus Pfizer

Pfizer CEO says coronavirus vaccine could be distributed to Americans before year’s end – Fox Business

Pfizer CEO Albert Bourla said on Sunday that it is a “likely scenario” that the company’s coronavirus vaccine could be distributed to Americans before the new year if it’s proven by federal regulators to be safe and effective.

“I cannot say what the FDA will do, but I think is a likely scenario and we are preparing for it,” Bourla said in an interview on CBS’ “Face the Nation.” “We started already manufacturing and we have already manufactured hundreds of thousands of doses, so just in case we have a good study readout, conclusive and FDA, plus the advisory committee feels comfortable, that we will be ready.”

Though Bourla said Pfizer’s studies show that there’s “a good chance that we will know if the product works by the end of October,” he noted that distribution before the end of the year ultimately comes down to if and when regulators like the Food and Drug Administration issue a license.

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Pfizer’s vaccine candidate, which is being developed in partnership with BioNTech, is moving to its Phase 3 trial and is expected to reach its initial enrollment target of 30,000 participants by next week.

The pharmaceutical giant has announced plans to expand its trial to approximately 44,000 participants to increase the diversity of those involved in the study and to include more vulnerable populations, like adolescents as young as 16 years old and people with chronic stable conditions like HIV, Hepatitis C, or Hepatitis B infection.

“I think we should strive to have as more a diverse population as possible, but right now we are not bad, actually. We have a population that globally, only 60% are Caucasians, 40% approximately minorities,” Bourla said. “Also, 44% are older people. We try of course to increase it, particularly an emphasis on African-Americans and Latinos.”

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Since the start of the coronavirus pandemic, the White House has funneled nearly $10 billion as part of its Operation Warp Speed initiative to accelerate the development of a COVID-19 vaccine, with at least six pharmaceutical companies taking a taxpayer-funded investment. Bourla, however, said he turned down the taxpayer money for the development of the vaccine in an effort to “liberate our scientists from any bureaucracy.”

“When you get money from someone, that always comes with strings,” Pfizer’s chief executive said. “They want to see how you’re going to progress, what type of moves you’re going to do, they want reports. I didn’t want to have any of that. Basically, I gave them an open checkbook so that they can worry only about scientific challenges, not anything else. And also, I wanted to keep Pfizer out of politics, by the way.”

While Bourla acknowledged the possibility Pfizer’s vaccine candidate could fail, he argued that he doesn’t believe any potential financial hit will “break the company” despite investing at least $1.5 billion in the effort.

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The federal government announced in July that it had reached a $1.95 billion agreement with Pfizer and BioNTech for at least 100 million doses following its approval by the FDA. Under the agreement, an additional 500 million doses can be acquired, and U.S. citizens would receive the vaccine for free.

There are more than 6.4 million confirmed coronavirus cases in the United States with more than 193,000 related deaths, according to the latest update from Johns Hopkins University.

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Coronavirus Pfizer

Pfizer, US Reach $1.95 Billion Coronavirus Vaccine Deal : Coronavirus Live Updates – NPR

The agreement also would allow the federal government to acquire an additional 500 million doses of the Pfizer vaccine.

Jeenah Moon/Bloomberg via Getty Images


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Jeenah Moon/Bloomberg via Getty Images

The agreement also would allow the federal government to acquire an additional 500 million doses of the Pfizer vaccine.

Jeenah Moon/Bloomberg via Getty Images

The federal government has reached a $1.95 billion deal with Pfizer to acquire 100 million doses of its vaccine candidate against the coronavirus if the Food and Drug Administration OKs it. The vaccine would be free to Americans, according to the deal, though health care providers could charge to administer it.

The Department of Health and Human Services and the Department of Defense announced the deal Wednesday as part of Operation Warp Speed, the Trump administration’s push to have a coronavirus vaccine widely available by January.

Pfizer is working on the vaccine with BioNTech, a German company. Clinical trials began in April, and Pfizer announced positive early results this week, though it has yet to announce that data have been vetted and published in a medical journal. Larger safety and efficacy studies could begin later this month.

“If the ongoing studies are successful, Pfizer and BioNTech expect to be ready to seek Emergency Use Authorization or some form of regulatory approval as early as October 2020,” the company said in a statement.

AstraZeneca, Johnson & Johnson, Moderna and Novavax have already received large contracts as part of Operation Warp Speed.

“Through Operation Warp Speed, we are assembling a portfolio of vaccines to increase the odds that the American people will have at least one safe, effective vaccine as soon as the end of this year,” HHS Secretary Alex Azar said in a press release.

The agreement also allows the government to acquire an additional 500 million doses of the Pfizer vaccine.

Concerned about price gouging, U.S. Rep. Jan Schakowsky, D-Ill., asked vaccine manufacturers at a House Committee on Energy and Commerce hearing on Tuesday whether they would commit to selling their vaccines at no profit.

Moderna and Merck declined to make this pledge. AstraZeneca said its existing deal with the federal government stipulated that it would sell 300 million doses to the government “at no profit.” Johnson & Johnson said it would provide its vaccine “at a not-for-profit price during the pandemic.” Pfizer did not make a similar statement in its announcement of Wednesday’s deal, and Schakowsky noted that the company had previously said it would sell its vaccine for a profit.

“We recognize that these are extraordinary times, and our pricing will reflect that during the term of the pandemic,” Pfizer’s chief business officer, John Young, said during the hearing. “We’ll price our potential vaccine consistent with the urgent global emergency that we’re facing. And secondly we also believe, and critically, that COVID vaccines should be free to the public. A vaccine is meaningless if people are unable to afford it.”

He applauded the CARES Act, which he said would allow many patients to get the coronavirus vaccine with no cost-sharing. “We’ll see what that means,” Schakowsky said.

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