WASHINGTON – US President Donald Trump accused pharmaceutical giant Pfizer on Friday of delaying the announcement of positive results from trials of a COVID-19 vaccine until after the Nov. 3 election to damage his chances of winning a second term.
“Big pharma ran millions of dollars of negative advertisements against me during the campaign, which I won by the way,” he said at the White House during a speech on bringing down prices of prescription drugs.
“Pfizer and others even decided to not assess the results of their vaccine, in other words not come out with the vaccine, until just after the election,” Trump said.
The Republican incumbent, who has yet to concede that he lost the election to Democratic challenger Joe Biden, suggested that Pfizer withheld the news in retaliation for his administration’s action on drug pricing.
“Instead of their original plan to assess them (the vaccines) in October – they were going to come out with it in October – they decided to delay it because of what I am doing, which is fine with me, because frankly it is just a very big thing, what I am doing here,” Trump said.
On Nov. 9, Pfizer and partner BioNTech SE said that their vaccine candidate had proved 90 percent effective in Phase 3 clinical trials. Moderna, a comparatively tiny firm with no products, announced encouraging results on its drug a few days later.
“So they waited and waited and waited and thought they would come out with it a few days after the election, and it would probably have had an impact. Who knows? Maybe it wouldn’t have,” the president said.
“You wouldn’t have a vaccine if it wasn’t me for another four years,” Trump said, alluding to Operation Warp Speed, his administration’s plan to expedite the development of a vaccine.
Moderna’s vaccine research was funded in part by Operation Warp Speed and while Pfizer has financed its own development efforts, it did sign an agreement to sell a minimum of 100 million doses of the vaccine to the federal government for $1.95 billion.
During the election campaign, Trump repeatedly predicted that a vaccine would be available by Nov. 3, though the government’s own experts said the more likely timeline was December or January.
Trump comments came on the same day that Pfizer and BioNTech asked the Food and Drug Administration (FDA) to allow their COVID-19 vaccine to be administered to high-risk people in the United States.
The FDA is expected to decide within weeks on the request for an Emergency Use Authorization for the drug, BNT162b2, meaning that vaccinations could begin as soon as the middle of next month.
Pfizer, which is based in the US, and Germany’s BioNTech said earlier this week that the latest data from Phase 3 clinical trials involving nearly 44,000 people worldwide showed BNT162b2 to be 95 percent effective at preventing infection with the coronavirus.
The vaccine, which is given in two doses, was 94 percent effective among test subjects older than 65, the demographic at the highest risk of dying from COVID-19, the companies said.
The US remains the epicenter of the global pandemic, with more than 252,000 fatalities and 11.8 million confirmed cases.
“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally,” Pfizer Chairman and CEO Albert Bourla said.
“Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” he said.
The firms said they are simultaneously seeking regulatory approval from health authorities in Australia, Canada, Japan, Europe and the United Kingdom.
“As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency are of particular importance to us and we have continuously provided data to them as part of our rolling review process,” said the CEO of BioNTech, Dr. Ugur Sahin.
All but eight of the 170 participants in the clinical trials who tested positive for COVID-19 received the placebo, while 41,135 had gotten a second dose of BNT162b2 as of Nov. 13.
The monitoring committee appointed by the US National Institutes of Health for the study has not raised any serious safety concerns.
The submission to the FDA includes safety data on some 100 children between the ages of 12 and 15.
Roughly 42 percent of test subjects were of diverse racial and ethnic backgrounds and more than 40 percent were in the 56-85 age bracket.
Observers have pointed out that the handling requirements for the Pfizer/BioNTech drug, which must be maintained at a temperature of minus 70C (minus 94F), could represent a challenge for less-developed countries.
But Pfizer, the world’s second-biggest pharmaceutical firm, said it was “confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world.”
Pfizer and BioNTech said they have the capacity “to supply up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021.”
Founded in 1849 and with more than 88,000 employees, Pfizer is vying with tiny Moderna, a 10-year-old firm with a staff of fewer than 900, to be the first to introduce a coronavirus vaccine in the US.
Moderna said on Monday that its vaccine candidate demonstrated 94 percent effectiveness in clinical trials.
The company noted that its formula can be transported and stored at temperature in the range of 2-8C (36-46F), “the temperature of a standard home or medical refrigerator.”
Moderna said it will approach the FDA “in the coming weeks” to request Emergency Use Authorization for its vaccine.
Other vaccine candidates currently undergoing Phase 3 clinical trials include one developed by British-based AstraZeneca in collaboration with the University of Oxford; CoronaVac, a creation of China-based Sinovac Biotech; and Russia’s Sputnik V.
During her first news conference in more than a month, White House Press Secretary Kayleigh McEnany pointed on Friday to the progress of the Pfizer and Moderna projects as heralding the “beginning of the end” of the coronavirus outbreak.
She said that around 40 million doses of vaccine would be available in the US by year’s end.
Trump’s “unprecedented response” to the pandemic has saved many lives, McEnany said.