(Bloomberg) – New Food and Drug Administration regulations on the development of the Covid-19 vaccine may dampen Wall Street’s hopes that a vaccine to prevent the spread of the pandemic will be available before the US election in November .
With FDA standards for an emergency use authorization not much lower than what is needed for full approval, the first authorization seems more likely to occur in early 2021, said Geoffrey Porges, analyst at SVB Leerink.
The agency’s guide, published Tuesday, said any vaccine candidate would need to be tested at least 50% more effective than a placebo to obtain approval, and that simply showing immune response data would not be enough.
“It’s hard to see how those studies could enroll thousands of patients, vaccinate them, and then watch them for safety for six months or more, and then get approved” before the end of the year, Porges wrote in a note to clients. A fully approved vaccine will need “extensive safety data and full clinical efficacy,” he said.
Investors anticipated that the first vaccine could arrive in the fall after President Donald Trump pressured health officials in his reelection bid. Drug and vaccine developers, including Johnson & Johnson, Merck & Co., Pfizer Inc. and Moderna Inc., are participating in the administration’s “Warp Speed” program. The government program is aimed at scaling up efforts to develop a vaccine faster than any that has been developed before, although details are sparse.
Pfizer bounced back to 5.6% on Wednesday after initial data with partner BioNTech SE showed promising effects for a vaccine candidate, while small-cap vaccine developer Inovio Pharmaceuticals Inc. fell 27%. Moderna, one of the leaders in space, fell 7.9%. All three vaccination programs would likely need longer-term results to clearly establish safety, according to Porges. DNA vaccines in particular, like Inovio’s, can “be kept to a stricter standard given general concerns about the risks of genetic integration.”
Porges does not see a 2020 vaccine, and “the success of that effort is not an inevitable conclusion,” he said. Instead, he predicts that full approval of the vaccine may come in another two to three years, and widespread adoption will take another year after that.
If a vaccine is approved, getting enough Americans to vaccinate will be another obstacle to changing Covid-19’s course. Yesterday’s guidelines are meant to depoliticize the government’s vaccination efforts so that people are not afraid to get vaccinated, Beacon Policy Advisors founder Brandon Barford said in a phone interview.
“They are trying to come up with very prescriptive guidelines so that outside experts can quickly try to validate the studies and help with public health efforts,” Barford said. The stock market has not incorporated “enough analysis around the policy of a vaccine and how, even if science complies, our political leaders may fail the test by over-politicizing the process to the point that it will take longer than expected to enough that people agree to be vaccinated to achieve mass immunity in the United States, “according to Barford.
But the tone of US regulators should reassure citizens, as it “suggests that regardless of political pressure, the FDA continues to apply good regulatory judgment and experience to the development of all medical products, in Vaccines in particular, regardless of the severity of the economic, political or public health urgency of the current situation, “Porges said,” for that integrity, the general public, the biopharmaceutical industry and all its investors should be grateful. “
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