Pfizer and BiNTech announced they have developed a coronavirus vaccine that is 90 percent effective in preventing COVID-19, in a matter of months.
Vaccine development is a huge gamble for drug manufacturers, but to motivate and help companies overcome hurdles, the Trump Administration launched a public/private partnership known as Operation Warp Speed. On July 22, the Administration announced the federal government would in effect, purchase 100 million doses of vaccine, $1.95 billion in funds to Pfizer, “if it successfully receives FDA (U.S. Food and Drug Administration) EUA (emergency use authorization) or licensure, as outlined in FDA guidance, after completing demonstration of safety and efficacy in a large Phase 3 clinical trial, which began July 27.”
On November 9, the companies announced, in a trial of 43,538 participants, they developed a safe vaccine that appears to have an efficacy rate of 90 percent at 7 days after the second dose and 28 days after the first. Participants, recruited from around the globe, were given two vaccines during the blind trial. Half received a placebo. Ninety-four participants became infected with the virus, with 90 percent on the placebo. The Stage 3 trial will continue until it reaches 164 COVID-19 cases
“When we embarked on this journey 10 months ago, this what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality,” said Professor Ugur Sahin, BioNTech co-founder, and CEO.
The “Third” Prong
Five companies, including Pfizer/BiNTech, are in late-stage trials with their vaccines, meaning the vaccines have passed early trials on safety and are now examining efficacy.
The Trump Administration has been widely supportive of developing the vaccine “prong” in controlling COVID-19. The two other attack routes include controlling transmission through public mitigation such as lock-downs, masks, social distancing, and contact tracing, and treatment.
Like vaccines, the Trump Administration has been supportive of the treatment approach. President Trump was treated with Remdesivir and monoclonal antibody therapy when he was hospitalized in October with COVID-19. Physicians continue to urge FDA and the National Institutes of Health to allow more flexibility in early at-home treatment with the off-label use of approved antiviral drugs and Trump has touted one, hydroxychloroquine.
Vaccine development is a challenge, all together. Vaccine development can last 10 years or longer and many trials fail.
“Operation Warp Speed and Trump Administration regulatory efforts played a key role in accelerating the speed with which clinical studies could be undertaken, including the concurrent performance of steps that in the past had been sequentially performed,” Roger Klein, M.D., J.D. and advisor to The Heartland Institute, told Health Care News.
In a City Journal op-ed, Klein wrote, “It is unprecedented for any national system to have accelerated the development of a vaccine to this point in so short a time.”
HHS published a plan for to distribute the vaccines, entitled “From the Factory to the Frontlines.” Klein says it is one of the best governmental administrative documents ever written. “It is an innovative, well-thought-out, impressive distribution plan using military-style logistics,” said Klein. Klein spoke about the plan September 17, on Fox Business News.
Now, the Politics
The next hurdle will be to determine who will get the vaccine and how it will be distributed. An incoming administration could be a big factor in calling the shots.
Hours after Pfizer and biNTech made their announcement, Governor Andrew Cuomo told ABC News that a Biden Administration should be making all the decisions. “The Trump Administration is rolling out the vaccination plan and I believe it’s flawed,” said Cuomo. “They’re basically going to have the private providers do it, and that’s going to leave out all sorts of communities that were left out the first time when COVID ravaged them.”
Companies would have to manufacture millions of vaccines to achieve herd immunity of 60 percent of the population. In the U.S., with two doses, that could mean manufacturing and distributing 200-300 million vaccines, or more. Pfizer says it could produce 1.3 billion doses in 2021.
Given the $10.7 billion it has spent upfront for COVID vaccine trials and development, another issue is who will pay for the vaccine and whether the U.S. government has “ownership” Drug ownership has been a celebrated cause for some Democrat members of Congress, who believe the U.S. government should have a public stake if tax dollars are used to get a product to market.
Additionally, Pfizer and biNTechs announcement on November 9, two days after the Associated Press declared Joe Biden to be president-elect, appears to have political overtones. In its release, the companies said after a discussion with the FDA, they decided “to drop the 32-case interim analysis and make it at 62.” The trial began on July 27.
The release then stated in expects to ask for Emergency Use Authorization the third week of November. While it is unclear when all participants received their second dose, FDA guidance calls for two months of safety data after that final dose. That would mean the vaccine was showing effectiveness by early October.
On October 28, Dr. Anthony Fauci, the government’s most visible spokesperson on COVID, told JAMA Network, “somewhere around December, you will start to see companies with enough events.” Fauci then stated a EUA could come in January, or later.
“Political considerations could be playing a role in the company’s statements – an effort to curry favor with an incoming Biden Administration and perhaps displeasure at the President’s drug pricing initiatives, including his Executive Order calling for testing of a payment model for most favored nation pricing for Medicare Parts B and D,” said Klein. “Pfizer could (also) be attempting to affirmatively assert that the U.S. government has no rights in or ownership claims to the vaccine, such as march [in] rights.”
Did the FDA “deliberately help Biden win?” asks David Friedman, an economist, and legal scholar, on his blog, on November 11. “The more interesting question, for me, is whether Biden supporters believe that if it did happen (withholding the announcement), they approve,” wrote Friedman. “Also of interest is whether there are any Trump supporters who believe that, if it happened, it was a defensible, if unfortunate, decision, that they would approve if something similar had been done by someone on their side.”
AnneMarie Schieber (firstname.lastname@example.org) is managing editor of Health Care News.
This article was updated November 12, 2020.