NIH Director Collins More Hopeful About Early COVID Vaccine, As Companies Pledge Science Over Speed

In prepared remarks at a Senate hearing today, National Institutes of Health Director Francis Collins is expected to say that there is “growing optimism” that one of the multiple COVID-19 vaccine candidates will prove safe and effective by late 2020 or early 2021.

In earlier comments, Collins had said he did not think there would be a candidate ready for approval this year. Collins noted that the vaccine development timeline was shortened by moving forward with multiple steps simultaneously rather than by eliminating steps and by scaling up manufacturing while clinical trials are ongoing.

He is expected to reassure members of the Senate’s committee on Health, Education, Labor and Pensions that “no safety and efficacy assessments” will be skipped in evaluating COVID-19 vaccines.

Meanwhile, the CEOs of nine pharmaceutical companies racing to develop COVID-19 vaccines made an unprecedented pledge on Tuesday to “uphold the integrity of the scientific process” when filing for approval of their vaccines even as the politicization of the vaccine approval process appears to be worsening.

The unusual move was meant to ease the public’s doubts about the process used to evaluate and approve COVID-19 vaccines and comes as the push for a COVID-19 vaccine by year’s end heats up, with President Trump vowing Monday that a vaccine approval could come as early as October.

Top scientific experts disagree. Anthony Fauci, director of the NIH’s National Institutes of Allergy and Infectious Diseases, said on Tuesday that it’s unlikely a vaccine will be ready by the presidential election on Nov. 3.

Having a vaccine by that date is only possible if “there were so many infections in the clinical trial sites” that an efficacy signal arrives earlier than expected, Fauci said. He predicted that a vaccine will more likely show efficacy by November or December.

In a press conference Monday, President Trump said that a vaccine could be ready by the end of the year, possibly “during the month of October.” The Centers for Disease Control and Prevention (CDC) has also asked states to prepare for COVID-19 vaccine distribution by Nov. 1, just days before the presidential election.

On Tuesday, FDA Commissioner Stephen Hahn made another effort to reassure the public about the independence of the agency’s vaccine approval process, declaring via Twitter that the FDA’s “professional staff will only authorize or approve a COVID-19 vaccine if it meets the high standards that Americans expect for safety and effectiveness.”

The safety pledge came from CEOs at AstraZeneca, Pfizer, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax and Sanofi. Four of the companies, AstraZeneca, Moderna and Pfizer/BioNTech jointly, already have three vaccine candidates in phase 3 trials.

All of the companies pledged that they will only file for approval or Emergency Use Authorization for their vaccines after they have demonstrated safety and efficacy in a phase 3 trial.

They also pledged to maintain “high scientific and ethical standards” in clinical trials and the manufacture of the vaccines, and to make the safety and well-being of vaccinated individuals their top priority. They also committed to ensuring a range of vaccine options, “including those suitable for global access.”

Multiple polls have found that Americans are largely skeptical of the accelerated COVID-19 vaccine development process and believe that the Trump administration is pressuring the FDA to approve a vaccine before safety and efficacy thresholds have been met.

But the industry is backing the efforts of the pharma CEOs to address the skepticism. PhRMA CEO Stephen Ubl applauded the pledge and said the industry is prepared to respond to the pandemic quickly but “without cutting corners.”

The Biotechnology Innovation Organization (BIO) also endorsed the pledge, saying it “reaffirms our industry’s commitment to putting the health and well-being of individuals first and to trusting science as the best way out of this pandemic.” BIO previously called on drugmakers to adhere to certain standards when conducting vaccine trials and to ensure that politics do not influence the approval process.

Meanwhile, UK Health Secretary Matt Hancock said the “best-case scenario is to have a COVID-19 vaccine approved this year,” in the UK, but that it will most likely have a vaccine available in “the first few months” of 2021. — Jordan Williams