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J&J's COVID-19 vaccine approaches likely emergency nod from US FDA — experts

With Johnson & Johnson's coronavirus vaccine up for emergency use authorization — the third in the U.S. — at the end of the month, experts have indicated the decision is likely to favor the healthcare giant due to the shot's increased versatility.

The vaccine's 66% overall global efficacy in a late-stage study, rising to 72% in the U.S. alone, falls below that of Pfizer Inc.-BioNTech SE's and Moderna Inc.'s shots at 95% and 94.1%, respectively.

But the advisory committee set to meet Feb. 26 to vote on the emergency use authorization is likely to look at other factors such as the vaccine's one-shot regimen, its distribution potential and its 82% efficacy in preventing severe disease in particular, said Healthline Media Medical Affairs Senior Manager Jenny Yu, a public health specialist. The panel of outside experts will advise the U.S. Food and Drug Administration on the vaccine's authorization, but cannot determine the ultimate decision.

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Healthline Media Medical Affairs Senior Manager Jenny Yu
Source: Healthline

"I think that J&J is going to be a great option for people who are having an access or availability issue with vaccines in general," Yu said. "The nice thing about J&J is that, even though its efficacy isn't as good as the Pfizer and Moderna vaccines that are out there, it still can prevent severe disease, so it keeps people out of the hospital and it has less stringent requirements in terms of storage and transportation."

Both Pfizer and Moderna's vaccines require two doses according to their own authorizations, and the one-shot option from J&J would allow for a more accessible public health response, Yu said. Most Wall Street analysts also agree the shot is likely to be authorized.

J&J — which expects to provide 1 billion doses of the vaccine in 2021 — has said it is ready to distribute the vaccine upon authorization with the same technology the pharmaceutical giant uses to transport other cold-chain medicines.

"There are going to be issues of access and availability in terms of patients getting to the right places for vaccinations," Yu said. "So having the one-dose vaccine really opens up the options for people who have challenges from a transportation or availability standpoint."

And compared to the ultra-cold refrigeration required by Pfizer and Moderna's mRNA vaccines, J&J's — which is based on adenovirus technology to prompt an immune response — requires only standard cold-chain delivery.

These factors could help with the vaccine's distribution to populations of rural areas of the U.S. with fewer resources, and Yu said they could also enable J&J to think more globally about the vaccine's reach.

But while Pfizer executives expect to bring in $15 billion in coronavirus vaccine sales in 2021, J&J has committed to distributing their own shot on a not-for-profit basis while it is under emergency authorization.

The vaccine race, accelerated

Cowen analyst Joshua Jennings cautioned investors not to make "inappropriate comparisons" between the three vaccines because no head-to-head study took place.

"J&J's study was conducted at a different stage of the pandemic and given the global evolution of COVID-19 with new variants coming into play, we would dissuade investors from making cross-trial comparisons with the results from the Pfizer and Moderna studies," Jennings said. "Overall, we believe the results will drive worldwide regulatory approvals, and J&J's single-shot vaccine candidate will become an important addition to the global COVID-19 vaccine rollout."

Yu said data collection on all COVID-19 vaccines will continue for a long time to increase understanding about their effects. But at the height of the pandemic, the need to vaccinate outweighs the type of vaccine a government will request.

"We're in these extraordinary times in which we are trying to get as many people vaccinated as we can," Yu said. "I think head-to-head trials are important as we go forward, and I think there will be opportunities for that."

Production and distribution are likely to continue to ensure the COVID-19 market is relatively even for all approved vaccines, at least in the short term — governments that under-ordered Pfizer's or Moderna's vaccine could back their supply up with J&J's, RBC Capital analyst Randall Stanicky said in a Jan. 29 note.

While new coronavirus variants have become a topic of heated discussion in recent weeks, the companies have said the use of newer vaccine technologies at hand means all three shots have the capability to be tailored to address these new threats.

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Analysts torn on J&J data

Many analysts agree that J&J's vaccine would add substantially to the vaccine landscape in the battle against COVID-19, but deeper dives into the shot's clinical trial results have presented a more level takeaway.

RBC's Stanicky said that although the vaccine would likely be approved, the overall efficacy was "disappointing" for J&J's ability to capitalize on the effort.

"Bottom line, this is well under the 80% over/under hurdle the buyside had seemingly been pointing to and will read as a disappointment for J&J," he said at the time. But Stanicky, like Yu, emphasized the vaccine's effectiveness in severely infected patients.

"While this vaccine may not be the consensus first choice for those in higher-risk groups, we believe it is a feasible option to help reduce sickness in the broader population (especially in the context of current production constraints on approved vaccines)."

Cantor Fitzgerald analyst Louise Chen said in a note the same day that the vaccine would likely be a "workhorse" in fighting the pandemic and a boon for J&J. "The data underscore good efficacy, safety and a one-dose vaccine that should be logistically easy to ship," Chen said.