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Pfizer Inc said Friday that it could apply for U.S. authorization for the Covid-19 vaccine it is developing by the end of November, suggesting that a vaccine could be available in the United States by the end of the year.
However, this timeline makes it unlikely that a vaccine will be available before the US election, as President Donald Trump promised.
Pfizer, which is developing the vaccine with German partner BioNTech, said it could confirm whether the vaccine is effective as early as this month, but it also needs safety data from a 44,000-person clinical trial that won’t be available until next month. .
The news from Pfizer, published in a letter from its CEO on its website, lifted the US stock market and the company’s shares. Shares fell slightly in rival vaccine maker Moderna Inc, which is close to Pfizer on vaccine development.
“Let me be clear, assuming positive data, Pfizer will apply for the use of emergency authorization in the US shortly after the safety milestone is achieved in the third week of November,” said Pfizer CEO Albert Bourla. , and noted that he published the letter to provide greater clarity on the vaccine schedule.
People around the world are counting on a vaccine to control the spread of the coronavirus, which has killed more than a million people and devastated the global economy.
Fears of delays arose after trials of two rival vaccines were suspended in the United States in recent weeks.
Trump has repeatedly said that a vaccine would be available before the November 3 election.
When asked about the Pfizer news, White House spokesman Judd Deere said: “The president remains optimistic that we will have one or more vaccines very soon, before the end of the year.”
The US government’s Operation Warp Speed program has spent billions of dollars developing vaccines and treatments. You have signed an agreement to buy the Pfizer vaccines if they work.
But the rush to develop a vaccine has raised concerns that the US Food and Drug Administration, acting in a hurry, might not conduct a proper review.
US health officials have tried to mitigate those concerns. Earlier this month, the FDA formalized a requirement that vaccine manufacturers collect two months of safety data on half of the trial participants.
Pfizer has been trying to show that its decision-making is driven by science rather than politics, said Mizuho analyst Vamil Divan.
“Getting it to market is just a small part,” Divan said. “People should be willing to accept it.”
Rival vaccine maker Moderna could also apply for an emergency use authorization (US) this year. He has said he may have provisional data on his trial of 30,000 people as early as November.
Both companies are also applying for approval in Europe, where they compete against AstraZeneca PLC. AstraZeneca’s trial in the United States has been on hold since September, while another trial in the United States of a Johnson & Johnson candidate was paused earlier this week.
After the FDA announced the two-month requirement on October 6, which was approved by the White House but undermined the likelihood of a vaccine before voters go to the polls, Trump called the measure “successful political work. “.
In addition to safety and efficacy, the FDA will also review Pfizer’s vaccine manufacturing operations.
A BioNTech spokeswoman confirmed the deadline for the possible US application to the FDA.
Reuters
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