Covid-19 roundup: Pfizer lands massive $5B+ deal with US for potential pill; Boosters for all adults are incoming
Pfizer’s pill to treat Covid-19 is outpacing its top rival from Merck not only in terms of efficacy data but now in the size of its US government contract, too.
The US on Thursday announced it will pay $5.29 billion for 10 million courses of Pfizer’s potential treatment, which is the largest single procurement of any therapeutic or vaccine since the pandemic began. And at $529 per course for the Pfizer pill, that’s significantly cheaper than the $2.2 billion the US paid for just 3 million courses of Merck’s treatment, which adds up to about $730 per course.
Both companies are still seeking EUAs to market their products, although based on the size of these deals, those decisions from FDA may seem like an afterthought.
Data from a scheduled interim analysis for Pfizer’s potential drug showed an 89% reduction in risk of Covid-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset. Pfizer said it halted enrollment in the trial because of the positive results, and in consultation with the FDA.
Meanwhile, Pfizer said it will continue to invest up to about $1 billion to support the manufacturing and distribution of its pill, including exploring potential contract manufacturing options. And Pfizer announced a decision earlier this week to sign a voluntary licensing agreement with the Medicines Patent Pool to help expand access.
US government to invest billions in mRNA manufacturing, with Pfizer and Moderna’s help
Yesterday’s press briefing from the White House COVID-19 Response Team unveiled an interesting new nugget of info on how this administration is planning to ramp up vaccine manufacturing, although a lot of those plans will depend on the kindness of Pfizer and Moderna.
White House coronavirus response coordinator Jeff Zients told reporters that HHS is soliciting interest from companies that have experience manufacturing mRNA vaccines to identify opportunities to scale up their production capacity.
“Importantly, initial production could provide more mRNA COVID vaccines for the world. The goal of this program is to expand existing capacity by an additional billion doses per year, with production starting by the second half of 2022,” Zients said.
The program is geared to producing doses within six to nine months of identifying a future pathogen and ensuring enough vaccines for all Americans. BioNTech’s CEO told Endpoints in an interview last week that his company is trying to have a plan that would have a vaccine shipped within three months of identifying a new variant.
The plan currently is to “combine the expertise of the U.S. government in basic scientific research with the robust ability of pharmaceutical companies to manufacture mRNA vaccines. We hope companies step up and act quickly to take us up on this opportunity to expand production of mRNA vaccines for the current pandemic and set us up to react quickly to any future pandemic threats,” Zients said.
Coming soon: Moderna and Pfizer booster shots for all adults
Moderna and Pfizer have now both asked the FDA to sign off on their booster shots for all adults, which the agency could OK as early as this week, according to the New York Times.
The CDC’s advisory committee is meeting tomorrow for three hours in the afternoon to discuss the booster efficacy and safety data, which some critics have said is flimsy, and entirely based on Israeli data. But so far, 31 million Americans have now received boosters too, according to Zients.
And CDC Director Rochelle Walensky offered supporting data on Wednesday, telling reporters:
In recent weeks, we have also seen additional data that reinforce the importance of COVID-19 boosters for these populations at higher risk of severe disease, particularly to ensure protection against severe illness and hospitalizations…When we compare rates of COVID-19 disease between those who are vaccinated with two doses and those who have received a booster dose, the rate of disease is markedly lower for those who received their booster shot, demonstrating our boosters are working. FDA is currently evaluating data on the authorization of booster doses for all people over age 18. As we’ve done before, CDC will quickly review the safety and effectiveness data and make recommendations as soon as we hear from FDA.