Investor Alert

March 1, 2021, 4:38 p.m. EST

FDA authorizes the first single-dose COVID-19 vaccine

Jaimy Lee

The Food and Drug Administration on Saturday granted emergency authorization to Johnson & Johnson’s COVID-19 vaccine, making it the third vaccine to become available to Americans during the pandemic and the first to only require one dose.

The vaccine is authorized to be given to adults who are at least 18 years old.

J&J’s (NYS:JNJ) COVID-19 vaccine differs significantly from the vaccines developed by BioNTech SE (NAS:BNTX) /Pfizer Inc. (NYS:PFE) and Moderna Inc. (NAS:MRNA) , both of which received emergency use authorization from the FDA in December. An emergency use authorization is a type of regulatory approval that allows companies and regulators to more quickly bring medical products to market during the pandemic. It is not as rigorous as a full FDA approval.

The J&J vaccine only requires one dose, not two; it is adenovirus-based and doesn’t use mRNA-based technology; it can be stored in normal refrigeration temperatures; and it was much less efficacious in clinical trials than both of the mRNA-based vaccines, which had efficacy rates of about 95% in their Phase 3 clinical trials.

Johnson & Johnson’s shot had an overall efficacy rate of about 66%, with a slightly higher rate of protection in the U.S. at 72%, according to a FDA analysis of the company’s clinical-trial data . The efficacy rate increased to about 85% when it came to preventing severe or critical disease among participants in the U.S.

“This pandemic is very different from two months ago when other vaccine developers were running their trials and accruing cases. It’s a much more complex milieu at the moment,” Mathai Mammen, global head of research and development for J&J’s pharmaceuticals business, said in January, according to a FactSet transcript of an investor call. “Everywhere you look there are variants and running a study at this time puts significant pressure on the vaccine.”

The company’s late-stage study was conducted in part in South Africa, which is where the B.1.351 variant was first identified, and the vaccine was found to be about 64% efficacious there, which nearly all of the COVID-19 cases were found to be caused by that strain of the virus.

Wall Street analysts largely caution against direct comparisons of the vaccines, in part due to differences in trial design and timeline, especially as new variants like B.1.1.7 and B.1.351 have gained traction in recent months, but they generally view J&J’s vaccine as a key ingredient in reducing the impact of the virus in the U.S.

The J&J vaccine, which is referred to as Ad26.COV2.S, “is an effective single-dose vaccine with advantages in distribution that will likely contribute to substantially lowering the COVID-19 curve once available,” SVP Leerink analysts told investors on Feb. 24. “Though it remains premature to proclaim the beginning of the end for the pandemic, these data, along with EUA’s and availability for several vaccine candidates, signal to us that we are perhaps at ‘the end of the beginning.'”

The topic of spreading variants in the U.S. was one that came up several times during an advisory committee meeting on Friday. The committee, which convened Friday as part of the traditional FDA regulatory process, voted 22-0 that the vaccine’s benefits outweigh the risks, therefore recommending that the FDA authorize the vaccine.

About 22 million people in the U.S. have received both doses of either the BioNTech/Pfizer or Moderna vaccines since December, according to the Centers for Disease Control and Prevention . That’s about 7% of the total U.S. population.

The U.S. has already agreed to purchase 100 million doses of J&J’s vaccine in the first half of this year, though the first batch of doses that will be delivered with only be around 20 million, by the end of March, a J&J executive told lawmakers on Feb. 23.

J&J’s stock has gained 10.7% over the past 12 months, while the broader S&P 500 (S&P:SPX) is up 22.4%.

Link to MarketWatch's Slice.