FDA will review one-shot Johnson & Johnson vaccine that ‘could be a game changer’
Johnson & Johnson has applied for emergency use authorization from the FDA for its one-shot COVID-19 vaccine, which experts have said could help change the trajectory of the pandemic.
The FDA will not decide on the emergency use authorization (EUA) until after a meeting of the independent Vaccines and Related Biological Products Advisory Committee on Feb. 26.
In the meantime, the FDA said it will “thoroughly evaluate the data and information submitted in the EUA request before the meeting and to be prepared for a robust public discussion with the advisory committee members.”
In a phase 3 trial being conducted in eight countries, the vaccine was 85% efficacious at preventing severe disease and 66% efficacious overall at preventing moderate to severe disease, the company announced last week. Efficacy was reported to be 72% in the United States, 66% in Latin America and 57% in South Africa, where 95% of the COVID-19 cases that occurred during the trial were from the B.1.351 variant of SARS-CoV-2 that has raised some concerns over its ability to evade vaccines or treatments.
That variant was reported in the U.S. for the first time last week. Other variants — including one first identified in the United Kingdom — are also circulating, potentially complicating the country’s response to the virus.
Authorization of the Johnson & Johnson vaccine would give the country a third option for COVID-19 vaccination, and one that does not require a vaccinee to return for a second dose weeks later.
“This could be a game changer in the battle against COVID-19,” Cornelius (Neil) J. Clancy, MD, associate professor of medicine and director of the extensively drug-resistant pathogen lab and mycology program at the University of Pittsburgh, told Healio.
As of Feb. 4, nearly 57.5 million doses of the messenger RNA-based vaccines from Pfizer-BioNTech and Moderna have been distributed in the U.S., and almost 28 million people had received at least one dose, according to tracking by the CDC, although data compiled by other tracking projects suggest the U.S. could be even further along.
The Johnson & Johnson shot — a recombinant vector vaccine that uses a modified human adenovirus — has other advantages in addition to being a one-dose vaccine, experts have noted. It can be stored for at least 3 months at normal refrigeration temperature of 36°F to 46°F, unlike some other vaccines, which require extremely cold storage.
Last year, National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci, MD, said the vaccine “may be especially useful in controlling the pandemic if shown to be protective after a single dose.”
“An effective, single-dose vaccine without the logistical challenges imposed by the Pfizer and Moderna vaccines promises to significantly enhance the pace of vaccinations nationally,” Clancy said, although he acknowledged that the pace is dependent on the available supply of the Johnson & Johnson vaccine.
Johnson & Johnson said it expects to supply 100 million doses “in the first half” of the year, but as Bloomberg noted last week, a U.S. Government Accountability Office report said only around 2 million doses would be delivered upon issuance of an EUA, according to representatives of Janssen Pharmaceuticals, the Johnson & Johnson subsidiary that developed the vaccine.
“Coupled with the dramatic fall off in newly diagnosed cases in the U.S. over the past few weeks, prospects for a more normal summer than last look better than they did at the start of the year,” Clancy said. “We will need to follow the emergence of SARS-CoV-2 variants over the weeks and months ahead and understand what they mean for vaccine effectiveness and societal immunity. For now, however, this news is most welcome.”