Trump accuses FDA, Pfizer of deliberately delaying vaccine news after vote

US President Donald Trump falsely accused the United States Food and Drug Administration, drug maker Pfizer and Democrats on Monday of apparently conspiring to delay announcing progress on a coronavirus vaccine after last week’s election .

Pfizer Inc. said on Monday that its COVID-19 vaccine could be remarkably 90% effective, based on early and incomplete test results that nonetheless brought a great burst of optimism into a world desperate to find the means of finally bringing the catastrophic epidemic under control.

The announcement came less than a week after an election deemed a referendum on Trump’s handling of the scourge, which has killed more than 1.2 million people worldwide, including nearly a quarter of a million in just ‘in the USA.

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Although he applauded early Monday, Trump posted a series of tweets later Monday accusing Pfizer and the U.S. Food and Drug Administration of waiting until after the election to announce his positive vaccine news for political reasons.

“Like I said a long time ago, @Pfizer and the others would not announce a vaccine until after the election because they hadn’t had the courage to do it before. Likewise, the
@US_FDA should have announced it earlier, not for political purposes, but to save lives, ”Trump tweeted.

The @US_FDA and the Democrats didn’t want me to get a WIN vaccine, before the election, so it came out five days later – like I’ve always said! he added.

the @US_FDA and the Democrats didn’t want me to get a WIN vaccine, before the election, so it came out five days later – like I’ve always said!

– Donald J. Trump (@realDonaldTrump) November 10, 2020

Pfizer insisted that his work was not influenced by politics and that it “moved at the speed of science”. The company itself learned of the interim results on Sunday after its independent data controllers met to discuss them. The FDA was not involved in Pfizer’s decision to announce its first results and has not made any announcements on its part.

Pfizer initially chose not to join the Trump administration’s Operation Warp Speed, which helped fund the research and manufacture of vaccines for half a dozen vaccine makers. Instead, Pfizer said it has invested $ 2 billion of its own money in testing and expanding manufacturing capacity. But in July, Pfizer signed a contract to supply the United States with 100 million doses for $ 1.95 billion, assuming the vaccine was cleared by the FDA.

Pfizer said its only involvement in Operation Warp Speed ​​is that these doses are part of the administration’s goal of preparing 300 million doses of COVID-19 vaccine next year.

“We are potentially in a position to offer some hope,” Dr. Bill Gruber, senior vice president of clinical development at Pfizer, told The Associated Press. “We are very encouraged.”

Pfizer, which is developing the vaccine with its German partner BioNTech, is now on track to seek emergency use approval from the FDA later this month, once it has the necessary safety information. in hand.

Even if all goes well, authorities have stressed that a vaccine is unlikely to arrive well before the end of the year and that limited initial supplies will be rationed.

Dr Anthony Fauci, the top infectious disease specialist in the US government, said the results suggesting 90% effectiveness are “just extraordinary”, adding: “Few people expected it to be this high that.”

“This is going to have a major impact on everything we do with regards to COVID,” Fauci said as Pfizer appeared to be leading the total global race of pharmaceutical companies and various countries to develop a well-tested vaccine against the virus. .

Dr Bruce Aylward, senior advisor to the World Health Organization, said Pfizer’s vaccine could “fundamentally change the direction of this crisis” by March, when the UN agency hopes to start vaccinating people. high risk groups.

Global markets, already buoyed by the victory of President-elect Joe Biden, have rallied around the Pfizer news. The S&P 500 ended the day with a gain of 1.2%, while the Dow Jones Industrial Average rose more than 800 points. Pfizer stock rose more than 8%.

Yet Monday’s announcement doesn’t mean for sure a vaccine is imminent: This interim analysis, from an independent data watchdog, looked at 94 infections recorded so far in a study that recruited nearly 44,000 people in the United States and five other countries.

Some participants received the vaccine, while others received dummy injections. Pfizer has not published any specific breakdowns, but for the vaccine to be 90% effective, almost all infections must have occurred in placebo recipients. The study is continuing and Pfizer has warned that the rate of protection could change as more cases of COVID-19 are added to the calculations.

Earlier, Trump, who had repeatedly suggested during the presidential campaign that a vaccine could be ready by election day, tweeted: “THE STOCK MARKET IS GROWING, VACCINE COMING. 90% EFFICIENT REPORT. SUCH GREAT NEWS! “

Biden, for his part, welcomed the news but warned it could be several months before vaccinations become mainstream in the United States, and he warned Americans to rely on masks and distancing social in the meantime. He said the country was still facing a “dark winter”.

Confirmed infections in the United States eclipsed 10 million on Monday, the highest in the world. New cases are reaching all-time highs of more than 100,000 a day. And tens of thousands more dead are to be feared in the months to come, with the arrival of the cold and the holidays.

Pfizer’s vaccine is one of four candidates that are already being widely studied in the United States, and more are still being tested in other countries. Another American company, Moderna Inc., also hopes to file an application with the FDA at the end of the month.

The photos of the two companies are made with a whole new technology. These “mRNA vaccines” are not made with the coronavirus itself, which means that there is no chance that anyone can get it from the injections. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the enriched protein on the surface of the virus.