Source : 'Scrip Intelligence'
President Trump’s hopes of having a COVID-19 vaccine ready ahead of election day have been dashed after the US Food and Drug Administration issued guidance which makes an emergency authorization in October all but impossible.
The FDA guidance sets out high standards which it intends to use to assess COVID-19 vaccines via the Emergency Use Authorization (EUA), but which have been blocked by the White House until now.
It includes the key provision that vaccine developers should include a two month safety monitoring period after trial patients receives their final vaccinations – guidance which aims to provide greater reassurance on patient safety, but will extend likely EUAs well past the 3 November presidential election day.
“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate and is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research Director Peter Marks said in a statement.
Media reports indicate that White House officials will not oppose the guidance, however news of their release generated a predictably angry response from the president.
"New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!" the president tweeted, copying in FDA Commissioner Stephen Hahn for good measure.
However the news was greeted with relief and delight by the biopharma community on Twitter, who hailed it as a victory for science and the independence of the FDA.
Meanwhile Pfizer Inc., whose vaccine is seen to be the most likely to be first to apply for an EUA, denied claims that it was opposed the criteria outlined in the guidance.
The company issued a statement that it is “committed to bringing a vaccine to market that complies with the FDA’s criteria for safety, efficacy, and manufacturing” and “will support and meet or exceed whatever FDA guidance comes out of” the upcoming meeting of the FDA's Vaccines and Related Biological Products Advisory Committee on 22 October.
Pfizer Chairman and CEO Albert Bourla also tweeted that the company has never discussed the FDA’s coronavirus vaccine guidelines with the White House and never would do so because it would undermine FDA independence.
Bourla tweeted: The FDA’s “public servants are known for their high integrity and scientific expertise and we have full faith in their ability to set appropriate standards for the approval of a COVID vaccine or treatment.”
A rolling regulatory review of Pfizer Inc. and BioNTech SE's COVID-19 vaccine candidate BNT162b2 has been initiated by the European Medicines Agency, the agency announced on 6 October. The vaccine candidate is still in Phase III development, but the rolling review reflects the urgency to get a vaccine for COVID-19 to market quickly.
Pfizer/BioNtech's vaccine is the second COVID-19 vaccine that the EMA has fast tracked, after already initiating a rolling review for AstraZeneca's vaccine AZD1222. ("EMA Starts Rolling Review Of AstraZenecas COVID-19 Vaccine" "Pink Sheet" )
As with the AstraZeneca vaccine, the agency said that much of the evidence for BNT162b2 is still to be submitted. The rolling submission is based on positive data from preclinical and early clinical studies suggesting BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cell that target SARS-CoV-2, according to Pfizer.
"While the overall review timeline cannot be forecast yet, the process should be shorter than a regular evaluation due to the time gained during the rolling review," EMA said.
Under the rolling review, the EMA's Committee for Medicinal Products for Human Use (CHMP) has begun evaluating the early data and will continue to have a regular dialogue with the sponsors. Normally, all of the data would need to be submitted at the start of the evaluation in a complete application. A rolling review can help regulatory agencies reach an opinion sooner on the safety and efficacy of a product.
In the US, the US Food and Drug Administration has also indicated it could grant an emergency use authorization for a vaccine for high-risk individuals under a speedier than usual review, but the agency is also trying to balance a fast review while maintaining the public's trust.
By Scrip Team