President Donald Trump blasted the Biden administration and the FDA over the ‘pause’ in the Johnson and Johnson vaccine for the COVID-19 China coronavirus announced Tuesday morning. The FDA and CDC cited reports of six incidents of blood clots (including one fatality) out of seven million administered doses. Trump warned the pause would hurt vaccination efforts and questioned whether the FDA was working with rival Pfizer on the vaccine ‘pause’. Trump also brought up the announcement of the success of the Pfizer vaccine right after the November election, implying the results were delayed until after the election.
Statement by Donald J. Trump, 45th President of the United States of America
The Biden Administration did a terrible disservice to people throughout the world by allowing the FDA and CDC to call a “pause” in the use of the Johnson & Johnson COVID-19 vaccine. The results of this vaccine have been extraordinary but now it’s reputation will be permanently challenged. The people who have already taken the vaccine will be up in arms, and perhaps all of this was done for politics or perhaps it’s the FDA’s love for Pfizer. The FDA, especially with long time bureaucrats within, has to be controlled. They should not be able to do such damage for possibly political reasons, or maybe because their friends at Pfizer have suggested it. They’ll do things like this to make themselves look important. Remember, it was the FDA working with Pfizer, who announced the vaccine approval two days after the 2020 Presidential Election. They didn’t like me very much because I pushed them extremely hard. But if I didn’t, you wouldn’t have a vaccine for 3-5 years, or maybe not at all. It takes them years to act! Do your testing, clean up the record, and get the Johnson & Johnson vaccine back online quickly. The only way we defeat the China Virus is with our great vaccines!
StatNews, November 9, 2020 excerpt:
…“I’ve been in vaccine development for 35 years,” William Gruber, Pfizer’s senior vice president of vaccine clinical research and development, told STAT. “I’ve seen some really good things. This is extraordinary.” He later added: “This really bodes well for us being able to get a handle on the epidemic and get us out of this situation.”
…In their announcement of the results, Pfizer and BioNTech revealed a surprise. The companies said they had decided not to conduct the 32-case analysis “after a discussion with the FDA.” Instead, they planned to conduct the analysis after 62 cases. But by the time the plan had been formalized, there had been 94 cases of Covid-19 in the study. It’s not known how many were in the vaccine arm, but it would have to be nine or fewer.
Gruber said that Pfizer and BioNTech had decided in late October that they wanted to drop the 32-case interim analysis. At that time, the companies decided to stop having their lab confirm cases of Covid-19 in the study, instead leaving samples in storage. The FDA was aware of this decision. Discussions between the agency and the companies concluded, and testing began this past Wednesday. When the samples were tested, there were 94 cases of Covid in the trial. The DSMB met on Sunday.
Pfizer also notified the Biden campaign of the successful trials the night before notifying the Trump administration.
INBOX: @JoeBiden on Pfizer vaccine progress: “I congratulate the brilliant women and men who helped produce this breakthrough and to give us such cause for hope.”
But adds the battle against COVID is still ongoing, encourages mask wearing/social distancing pic.twitter.com/g1G6gvtFhq
— Johnny Verhovek (@JTHVerhovek) November 9, 2020
Pfizer CEO Albert Bourla said in an interview last week that Trump had told him that while Trump never asked him to do anything inappropriate and told him to put people first, he would also tell him that fast development of a vaccine would help his reelection bid (The Hill excerpt):
Pfizer CEO Albert Bourla says in an interview set to run Friday that former President Trump told him before last year’s election that a coronavirus vaccine could help his chances.
On clips from “The Carlos Watson Show” provided in advance exclusively to The Hill, Bourla says that Trump would call to encourage him to get the vaccine out quickly, but emphasized that “he never pressed me to do something that would be inappropriate with a vaccine.”
“In the few times that he was telling me that we need to do it fast — first he would say, ‘We need to do it quickly; people are dying,’ and then also he would add, ‘Of course it will help me also in the election, but people is the important thing.’”