Pfizer Inc said Friday that it will request authorization for the emergency use in the United States of its COVID-19 vaccine candidate around the third week of November, an announcement that makes it highly unlikely that immunization will be available before 8:00 p.m. American elections.
The American pharmaceutical company develops the vaccine together with the German firm BioNTech SE.
Pfizer said it could determine if the vaccine is effective as early as this month, based on its 40,000-person clinical trial, but that it also requires safety data that won’t be available until November at the earliest.
The news of Pfizer, published in a letter from its CEO on its website, boosted the US stock market and company shares.
“Let me be clear, assuming the data is positive, Pfizer will ask for emergency use authorization in the United States shortly after the safety goal is reached in the third week of November.”Said the CEO Albert Bourla.
The president of United States, Donald Trump, said a vaccine would be available before the Nov.3 election, but health officials and companies have only said that key data could be released this month.
The possibility of further delays was raised after clinical trials of two rival vaccines were suspended in the United States and other countries this fall.
Health authorities have sought to ease concerns about fears that few Americans will want to get vaccinated in the first stage. Earlier this month, the Food and Drug Administration (FDA) formalized a requirement for drug companies to provide at least two months of safety data for half of the volunteers in the trials.
Comments from Pfizer Right now they raise the possibility that the United States will approve a vaccine for the coronavirus this year, a crucial step in controlling the pandemic that has killed more than 1 million people and devastated the global economy.