Chief Pharmacists Pledge No Shortcuts in the Vaccine Race

Executives at the pharmaceutical company insisted on Thursday that they would not attempt to bring Covid-19 vaccines or treatments to market that do not meet rigorous safety and efficiency standards.

Around the world, governments hope to announce a vaccine as soon as possible and launch treatments for the new coronavirus, which has killed more than 860,000 people and infected more than 26 million.

But the sense of urgency has raised fears that companies and regulators are rushing to conduct tests aimed at ensuring that vaccines or treatments can be used safely and are actually effective against the disease.

“We are not taking shortcuts,” Pfizer chief Albert Bourla told reporters in a virtual briefing.

Pfizer and its partner BioNTech hope to conclude phase III trials of the final stage of their Covid-19 vaccine candidate next month.

Several other senior pharmaceutical executives at the briefing, organized by the International Federation of Pharmaceutical Products Manufacturers and Associations (IFPMA), also pledged to maintain strict safety and efficiency standards before requesting authorization for new coronavirus vaccines or treatments.

‘You won’t sacrifice security’

Before taking these products to regulators, “we first met our own standards for safety and efficacy, which are high,” said Dave Ricks, director of Eli Lilly.

“We will not sacrifice safety under any circumstances,” agreed Merck CEO Kenneth Frazier.

His comments came a day after it was revealed that Washington had urged US states to prepare for a possible launch of the Covid-19 vaccine before November 1, raising concerns that the administration of the President Donald Trump is rushing to begin distributing a vaccine before the November 3 election.

Under normal procedures, test administrators must wait months or years to verify that candidate vaccines work and are safe.

However, the US Food and Drug Administration has raised the possibility of granting an emergency authorization to a vaccine before trials end.

The FDA has faced accusations from the medical community, which it has denied, that it is giving in to political pressure from Trump, who is behind Democratic challenger Joe Biden in the polls.

“I also understand that they are skeptical … because there is a lot of politicization (of) science right now,” said Pfizer boss Bourla.

But he stressed that “we ourselves will never submit any vaccine for authorization or approval before we consider it to be safe and effective.”

Bourla told reporters that more than 23,000 people were already enrolled in the trial, at 125 sites mainly in the United States and Brazil, and that companies expected to reach the necessary 30,000 participants “in a few days.”

He hoped by the end of October “to have enough events to say if the program works or not.”

‘Very complete process’

Daniel O’Day, director of Gilead, insisted that the process of obtaining an emergency use authorization is no easy task, noting his company’s experience obtaining one for its antiviral drug remdesivir, which has been shown to be effective in treat Covid-19.

“It is a very complete process,” he said.

Severin Schwan, a director at Roche, said the industry had demonstrated its commitment to data transparency and was dedicated to maintaining high testing standards despite pressure for results.

He pointed to his company’s disappointing findings that its arthritis drug, tocilizumab, sold under the brand name Actemra, was not itself an effective treatment for Covid-19, as anecdotal evidence had suggested.

“There is no way we can lower the standards when conducting our trials,” he said, adding that the Actemra trials “prove the point.”

Roche is still testing whether Actemra could be effective when combined with other drugs, including Gilead’s remdesivir.