These were the words of Pfizer (NYSE: PFE) CEO Albert Bourla in a Washington Post live interview earlier this month. He was referring to the prospect that the company, together with its partner BioNTech (NASDAQ: BNTX), may seek approval of the COVID-19 vaccine candidate BNT162b2 in the near future.
This statement was consistent with Bourla’s previous comments. In July, for example, he said Time magazine that Pfizer expected to know in September whether its vaccine is working or not. He added that this would pave the way for a quick Food and Drug Administration submission and even approval in October “if we’re lucky.”
Is this timeline really achievable? There is now another reason to believe that Pfizer may have its coronavirus vaccine ready in October.
Fix a date
FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah recently said the agency tentatively plans an advisory committee to meet on October 22, 2020 to discuss a vaccine for the coronavirus. So far, however, the FDA’s official schedule for advisory committee meetings does not include anything related to coronavirus vaccines.
Earlier this month, FDA Food and Drug Commissioner Stephan Hahn and Center for Biologics Evaluation and Research Director Peter Marks said they intended to ask the Vaccines and Products Advisory Committee Related Biologics (VRBPAC) to review any COVID-19 vaccine candidate seeking FDA approval. or emergency use authorization (EUA). They felt that the involvement of the advisory committee would be beneficial in ensuring transparency in the approval and authorization processes.
The FDA frequently uses advisory committees composed of experts in a particular field to review applications for regulatory approval of drug and vaccine candidates. The agency does not always make decisions based on recommendations from advisory committees, but often does; he did so almost 80% of the time between 2008 and 2015.
Shah did not nominate any vaccine candidates who could be considered at the scheduled advisory committee meeting. But based on Pfizer’s much-publicized goal of seeking approval in October, the experimental coronavirus vaccine developed by the big drugmaker and BioNTech will likely be on the list.
AZD1222, the vaccine candidate developed by AstraZeneca (NYSE: AZN) and the University of Oxford. Like Pfizer and BioNTech’s BNT162b2, AZD1222 is currently being evaluated in a large phase 3 clinical study.
the Financial Times recently reported that the Trump administration is considering speeding up AZD1222 for emergency use clearance. However, AstraZeneca said it had not discussed with the US government an EUA for its coronavirus vaccine candidate and said “it would be premature to speculate on this possibility.”
What about Modernof (NASDAQ: ARNM) MRNA-1273 as a potential third vaccine against COVID-19 that could be reviewed by an advisory committee in October? The biotech began a phase 3 study for the vaccine candidate at the end of July. But Moderna doesn’t expect to complete her study registration until September. The second dose of mRNA-1273, which is given 28 days after the initial dose, would not be given to patients enrolling in September through October.
It is possible (and perhaps even probable), however, that companies leading the race to develop a COVID-19 vaccine may provide preliminary data from early registrants that could be used to request an EUA from the FDA. .
The challenges for Pfizer
The sooner a safe and effective COVID-19 vaccine becomes available, the sooner the fight against the novel coronavirus will be won. While this public health benefit is undoubtedly a motivation for Pfizer, there is also a lot of money at stake for the drug maker.
In July, Pfizer and BioNTech signed an agreement with the US government to provide 100 million doses of BNT162b2 for $ 1.95 billion. This deal could be expanded in the future to allow the United States to purchase up to 500 million additional doses. But receiving all that money depends on FDA clearance or BNT162b2 approval.
Pfizer shares have been in negative territory since the start of the year despite investor enthusiasm for its COVID-19 program. The recent decision to replace the pharmaceutical stock on the Dow Jones Industrial Average did not help matters. Pfizer could use a major positive catalyst. A win for its coronavirus vaccine in October would likely do the trick.