FDA authorizes Pfizer-BioNTech Covid-19 vaccine
The first Covid-19 vaccine has arrived in America.
The FDA issued an emergency use authorization for the Pfizer-BioNTech vaccine late Friday, marking a historic turning point in the fight against a deadly pandemic, but that one will still leave a long road ahead as the Big Pharma and federal officials try to scale up and roll out limited doses while the virus continues to ravage the US.
The EUA comes 24 hours after a committee of outside experts voted 17-4 to recommend the agency authorize the vaccine. In a 44,000-person Phase III trial, the vaccine was 95% effective at preventing symptomatic Covid-19 and did not trigger serious adverse events, although it did induce mild symptoms such as headache and fatigue. The data was publicly reviewed by the FDA and published in The New England Journal of Medicine.
It is the fastest a vaccine has ever been developed, coming less than a year after the novel coronavirus broke out in China. It is also the first mRNA vaccine to ever be licensed, potentially heralding a new era in how vaccines are made for a multitude of infections.
Although now authorized, a vaccine will remain out of reach for the vast majority of Americans. Operation Warp Speed officials have repeatedly said they expect to distribute 20 million doses of the vaccine until, with those first doses likely reserved for healthcare workers and the elderly. But some hospitals and outside experts have warned that such rollouts may not be smooth, as cash-strapped states will struggle to get doses in arms and companies may encounter manufacturing delays.
Still, the EUA marks a pivotal moment for a country and a federal government that, having failed to scale up testing, adopt universal mask-wearing, or follow other repeated public health guidance, has come to rely on the advent of widely available inoculations to curb what has become a daily of onslaught of death.
Since the election, President Trump has made scant mention of the daily toll the pandemic is now taking on the US, with up to 3,000 Americans now dying of the virus per day. But he has sought to take credit for the Pfizer-BioNTech vaccine, publicly feuding with the Big Pharma over whether or not they were involved in Operation Warp Speed and holding a “Vaccine Summit” at the White House to take credit for hastening development.
The FDA’s decision Friday came after the president threatened to fire Commissioner Stephen Hahn if the agency did not issue an EUA by the end of the day.
The FDA had already released a statement saying they told Pfizer they were finalizing the authorization. And HHS secretary Alex Azar had already appeared on Good Morning America to announce that doses would arrive in American arms by Monday or Tuesday, telling George Stephanopoulos that the agency still needed time to hammer out information for doctors.
It is not clear whether the accelerated decision will result in Americans being inoculated any faster.
Over the summer, the US signed a purchase order for 100 million Pfizer vaccines and have an option to order 500 million more, but they may find it to difficult to acquire any of those additional doses before the summer. Former FDA Commissioner and Pfizer board member Scott Gottlieb told CNBC this month that the government turned down an offer from Pfizer to buy more doses after their initial efficacy data came out. (Azar denied the account, saying Pfizer never said how many extra doses they could offer).
The EUA is likely to be followed by a second EUA for the Moderna vaccine, which showed 94.5% efficacy in its own Phase III trial. An FDA advisory committee hearing is scheduled for Thursday. J&J is also expected to read out on their vaccine in January, with the AstraZeneca shot behind them.
It is possible that Moderna’s mRNA shot becomes the dominant vaccine in the US. HHS exercised an option to purchase an additional 100 million doses of the vaccine today, giving the US enough Moderna and BioNTech shots to vaccinate 150 million Americans by June.
The EUA is also a turning point for BioNTech, a German mRNA biotech run by a husband-and-wife scientists who long operated with less flash and less venture capital than their mRNA rivals in Cambridge. The company approached their pandemic effort with similar inconspicuousness, disclosing the program in a single line in the middle of an SEC document in February. They now stand as one of the most famous biotechs in the world.
It is also a win for Pfizer and CEO Albert Bourla, who bet big on BioNTech’s technology and chose to go alone, rejecting government funds and ultimately successfully developing the first proven Covid-19 vaccine. And it marks the culmination of decades of work from academics who worked to tame a molecule that much of the industry didn’t want to touch but which they saw as the future of vaccines and drug development. That includes Katalin Karikó and Drew Weissman at the University Pennsylvania, who licensed their tech to Moderna and BioNTech and who now work for the latter.
The UK and Canada authorized the vaccine earlier this week.
Even though its now authorized, studies on the vaccine will continue, as Pfizer continues to monitor volunteers in its trial and the CDC and other branches of the federal government roll out plans to monitor vaccine recipients across the country.