Donald Trump has accused the Food and Drug Administration of deliberately delaying work on a coronavirus vaccination in order to thwart his re-election hopes.
On Monday Pfizer announced that their vaccination was proved to be 90 per cent effective in clinical trials. Their data will now go to the FDA for approval, and once the FDA gives the green light a mass vaccination program can begin.
Donald Trump Jr said the timing was ‘nefarious’, and was because his father was hated by the pharmaceutical industry for forcing them to lower their prices.
On Monday night the president accused the FDA of seeking to sabotage his campaign too. The FDA is led by a commissioner appointed by the president.
‘The @USFDA and the Democrats didn’t want to have me get a Vaccine WIN, prior to the election, so instead it came out five days later – As I’ve said all along!’ he tweeted.
He tweet came as FDA authorized emergency use of Eli Lilly and Co’s experimental COVID-19 antibody treatment, which Trump has praised and vowed to make available free of cost for all Americans.
A major breakthrough has been announced in the search for a coronavirus vaccine
He insisted that his actions had resulted in the creation of a vaccine in record time, arguing that had Joe Biden been president, it would have taken far longer to find treatment.
‘If Joe Biden were President, you wouldn’t have the Vaccine for another four years, nor would the @USFDA have ever approved it so quickly. The bureaucracy would have destroyed millions of lives!’ he said.
And he said that the FDA had cost lives by the supposed hold up.
‘As I have long said, @Pfizer and the others would only announce a Vaccine after the Election, because they didn’t have the courage to do it before.
‘Likewise, the @USFDA should have announced it earlier, not for political purposes, but for saving lives!’
The timing of the announcement, which came soon after Biden claimed victory and less than a week after the election, has already raised questions given Trump had repeatedly said a vaccine would be ready before the election.
Pfizer had initially said it would know if its vaccine was effective by October but shifted that timeline last month to say it expects to seek US authorization from the FDA for emergency use of the vaccine in the third week of November. The drugmaker is still on track to meet that timeline.
In its announcement on Monday, Pfizer said the results of the interim analysis came after a discussion with the FDA. It is not yet clear exactly what those discussions involved or when they occurred.
The company only said that, based on those discussions, they had opted to conduct the interim analysis based on a minimum of 62 cases instead of an initial 32 case figure. The cases relate to the number of the 44,000 people involved in the trial that have contracted COVID-19. The 90 percent rate ended up being based on 94 cases.
Revealing such early data is unusual in a clinical trial and it wasn’t immediately clear why Pfizer opted to announce the early findings today. Pfizer’s CEO and its head of vaccine research immediately sought to distance themselves from the timing of the announcement, insisting they weren’t being driven by politics.
The announcement of the Eli Lilly antibody approval, six days after the election, will further infuriate the president, who is seeing enemies everywhere he turns.
The FDA said its emergency-use authorization was based on clinical trials showing that the treatment, bamlanivimab, reduced the need for hospitalization or emergency room visits in COVID-19 patients at high risk of disease progression.
It can be used for treating mild-to-moderate COVID-19 in adults and pediatric patients over the age of 12, the FDA said.
‘As illustrated by today’s action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments and providing sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,’ said Stephen M. Hahn, FDA Commissioner since December 2019.
‘Through our Coronavirus Treatment Acceleration Program, the FDA continues to work around the clock and use every tool at our disposal toward these efforts.’
The drug will start shipping out ‘immediately’ to the major distributor AmerisourceBergen, Lilly said.
Last month, the US government signed a $375 million deal with Lilly for 300,000 doses of the antibody drug to be distributed over the two months following its emergency use authorization (EUA).
The government will have the option to purchase another 650,000 doses through June 30.
Although Lilly did not specify how many doses are currently ready to go, it had previously stated that 100,000 doses of the its antibody drug could be made available within days of its EUA.
Bamlanivimab will be allocated to states weekly, depending on how many confirmed cases are recorded in Department of Health and Human Services (HHS) data for each jurisdiction over the previous seven days, an Informa editor reported on Twitter.
It’s unclear how much the drug will ultimately cost, or how the federal government will make good on Trump’s promise that the antibody treatment – a class of drugs that typically comes with a six-figure price tag – will be free to anyone who needs it.
Earlier on Monday Donald Trump Jr. was leading the doing his best to raise alarm at the timing of Pfizer’s COVID-19 vaccine ‘breakthrough’, which was announced two days after the election was called for Biden.
Donald Trump Jr. raised suspicion on Monday after Pfizer announced its vaccine was 90% effective, two days after the election went to Joe Biden, after previously delaying the results
Pfizer revealed its vaccine was 90 per cent effective among study participants and that it would produce 1.3billion doses – enough to treat 650million people – by the end of the next year.
The breakthrough was unexpected given the company’s CEO’s previous remarks that it would be towards the end of the month before they had significant data to submit to the FDA for emergency authorization.
In September, Pfizer CEO Albert Bourla promised that they would know whether or not the vaccine was effective by the end of October, a deadline that fit with Trump’s promise to find a vaccine that worked before the November 3 election.
But that deadline came and went with no news. America went to the polls on November 3. Many told pollsters that the handling of the crisis was one of the most important issues on their minds.
Then suddenly on Monday, after the entire country waited four days for an election result, Pfizer announced their breakthrough, touting it as a ‘great day for humanity’ and science.
Efficacy is one of three components he said the company had to consider when submitting it for FDA approval. The other two are safety and whether or not it can be mass-produced to the right standards.
While Monday’s announcement does not technically speed up the process of the vaccine being rolled out to the masses (Pfizer still says it needs until the end of November to collate all the data to ask for authorization), it drums up huge global excitement and has given some industries a huge boost in the markets.
Along with Pfizer’s own share price, airline stocks skyrocketed on Monday after the announcement as people finally saw a ‘light at the end of the tunnel’.
It also came at the same time as Biden started unveiling his COVID-19 task force.
Trump Jr. tweeted sarcastically: ‘The timing of this is pretty amazing. Nothing nefarious about the timing of this at all right?’
Data on how effective it was – the clearest sign of whether or not it works – had been expected by the end of October.
Pfizer said the results of the interim analysis came after a discussion with the FDA. It is not yet clear exactly what those discussions involved or when they occurred.
Pfizer did not announce the efficacy of its vaccine until Monday morning
SEPTEMBER 13: Pfizer’s Greek CEO, Albert Bourla, said they would know if the vaccine would be effective by the end of October
The company only said that, based on those discussions, they had opted to conduct the interim analysis based on a minimum of 62 cases instead of an initial 32 case figure. The cases relate to the number of the 44,000 people involved in the trial that have contracted COVID-19. The 90 per cent rate ended up being based on 94 cases.
Biden said he found out about it on Sunday night from his ‘public health advisors’.
He is not due to take office until January 20.
‘Last night, my public health advisors were informed of this excellent news.
‘I congratulate the brilliant women and men who helped produce this breakthrough and to give us such cause for hope,’ he said.
Biden went on to say that while it was good news, the fight against COVID was far from over.
Trump himself initially resisted questioning the timing of the announcement and instead tweeted his excitement over it.
He tweeted: ‘STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!’
New York Governor Andrew Cuomo went on Good Morning America to say that he and other governors were going to try to stop Trump’s roll-out plan.
‘It’s good news, bad news. The bad news is it’s about two months before Joe Biden takes over and it means this administration is going to be implementing a vaccine plan.
Joe Biden said on Monday that he was informed about the vaccine efficacy on Sunday night
Trump initially resisted questioning the timing of the announcement on Monday
Democrats are already trying to block the Trump campaign from rolling the vaccine out. On Monday morning, NY Gov Andrew Cuomo said he and other governors want to stop their plan before they do ‘damage’ by implementing it through private practices
‘It’s very important. The Trump administration is rolling out the plan and I believe it’s flawed.
‘When you deny a problem the way Trump did, you can never solve it. They’re going to go through the private mechanism – through drug market chains.
‘You have two months and we can’t let this vaccination plan go forward the way the Trump administration is planning it. I’ve been talking to Governors across the nation about that.
‘How can we shape the Trump administration vaccine plan to fix it or stop it before it does damage?’
Senator Ted Cruz said Cuomo’s remarks were ‘revealing’.
Trump’s handling of the pandemic was one of the Democrats’ main talking points throughout the campaign.
They slammed his failure to implement things like a nationwide mask mandate, and Biden has already announced his own task force to reverse some of Trump’s decisions.