Johnson & Johnson (JNJ) expects to release its COVID-19 vaccine data soon, which could result in an emergency use authorization before the end of February.
Chief executive officer Alex Gorsky on an earnings call Tuesday said the data is expected to be released “early next week,” boosting optimism for the company whose vaccine could be a game changer.
The single-shot vaccine would cost no more than $10, a significant discount compared to the two-dose vaccines currently on the market. The vaccine does not require ultra-cold or frozen temperatures for storage and is easier to administer. The news is also welcome as vaccine supplies remain strained amid unprecedented demand.
“I would be surprised if it was any more than two weeks from now that data will be analyzed and decisions would be made,” Fauci said on MSNBC last week.
J&J is also conducting a two-dose study, which is likely to have results available toward the end of the year, and the company is keeping an eye on emerging variants of the coronavirus, Gorsky said.
The question of whether or not vaccines will stand up against new variants is still largely unanswered, though Moderna provided some insight into the most concerning to-date— the B.1.351 variant from South Africa. The company saw its vaccine hold up, but with some loss of efficacy, prompting a plan to create a booster that specifically addresses the variant. Experts say the results for Moderna, specifically, are comforting, but could be a problem for less effective vaccines globally.
The South Africa variant has not been confirmed in the U.S., but experts suspect it is already spreading. A new variant originating in Brazil, known as P.1, was confirmed to be in the U.S. Monday by the Minnesota Department of Health.
Dr. Janet Woodcock, acting commissioner of the U.S. Food and Drug Administration (FDA), said the agency is watching variants closely as well.
“FDA has already given thought to developing a potential pathway, should changes need to be made to authorized COVID-19 vaccines or other products based on information on emerging variants. We are committed to having a public and transparent process around our path forward,” Woodcock said on Twitter.
An additional concern remains the durability of vaccine protection, which both Moderna and Pfizer are seeking to address with new studies for booster shots in clinical trial participants.
Meanwhile, as the country continues to struggle with vaccine distribution, incoming Biden administration officials and staff have been offered a first dose of the Pfizer/BioNTech vaccine, in a move to “ensure a COVID-safe working environment” in the White House.
Antibody treatment flux
Regeneron (REGN) released positive news about its antibody cocktail treatment, which holds promise to be used as a proactive defense against the virus, almost like a vaccine. The treatment is already approved for non-hospital at-risk patients.
The company said in a statement that its study showed 100% reduction in symptomatic infection and a 50% reduction in overall infection — including asymptomatic.
Antibody treatments, while holding significant promise to curb transmission and death, are labor-intensive options that can usually only be administered intravenously in a hospital setting. This has become an obstacle to more widespread use — as well as the cost of an infusion — which is why former Health Sec. Alex Azar was seen regularly hawking the treatment after the U.S. government bought Eli Lilly’s (LLY) treatment.
“We’ve allocated over 330,000 doses of these treatment to all states and territories, and many states do have product available ... There may be a therapeutic option that could help keep you out of the hospital,” Azar said last month.
The news from Regeneron is more hopeful as its administration is less labor-intensive, according to SVB Leerink in a note Tuesday, which anticipated full results in the early part of the second quarter leading to a potential emergency use authorization.
“We expect prophylactic antibody use will be an important tool in the fight against COVID for individuals at high risk of infection, or after exposure, supplementing vaccine rollouts and social distancing measures; and if efficacy and safety are ultimately comparable, we expect (Regeneron) to see better uptake than (Eli Lilly) given the more convenient administration,” the note said.
But the note also said that the news didn’t come with detailed data, and that still needed to be reviewed.
“We still don’t have much data on duration of prophylaxis from either REGN or LLY, and we’d also like to see additional data on demographics of trial participants,” the analyst added.
More from Anjalee:
Follow Anjalee on Twitter @AnjKhem.