The first Biden-era vaccine against COVID-19 is moving toward market

New bumps could trip up the big launch

The Biden administration is relishing the chance to put its new-and-improved distribution program on display with the release of the forthcoming Johnson & Johnson vaccine, but as the US Food and Drug Administration weighs authorization, expectations for a massive, imminent surge in available vaccine doses have been dashed. Federal health officials now expect to get fewer doses of the Johnson & Johnson vaccine in February and March, threatening their planned rollout.

Though the status of the Johnson & Johnson vaccine was brought up on the White House's weekly governors call Tuesday, several state officials and health providers tell CNN they're mostly in the dark about how the distribution will work. And due to a miscommunication over the production, CNN has learned the launch will be slower than federal health officials initially anticipated.

The administration is still expecting single-digit millions of doses if the Johnson & Johnson vaccine is authorized for emergency use by the FDA. Government officials initially thought that number would ramp up to between 20 or 30 million doses by April, but are now expecting fewer than 20 million Johnson & Johnson doses in April, an administration official told CNN. Federal officials have expressed disappointment that they now expect fewer doses to be ready once the vaccine is authorized.

This delays expectations by about a month. Officials do still expect to get 100 million doses by the end of June/beginning of July, but it's a significant hiccup in the final days before its expected authorization.

The Biden administration has been working closely with Johnson & Johnson, which signed a contract with the federal government while former President Donald Trump was in office. Biden officials are holding daily conversations with their employees, according to a person familiar with the relationship, to discuss what will be ready and when.

Johnson & Johnson did not directly address the slower vaccine rollout, but said in a statement: "Johnson & Johnson intends to distribute vaccine to the U.S. government immediately following authorization, and expects to supply 100 million doses to the U.S. in the first half of 2021. The Company expects to have product available to ship immediately following authorization."

The FDA has scheduled its meeting of independent experts to evaluate the vaccine and make a recommendation on February 26. It has not been authorized yet.

An administration official told CNN the White House did not want to get ahead of the FDA's approval with information on the distribution, but health industry experts are concerned the slowdown and lack of clarity could cause confusion and make a quick turnaround in delivery of the shots more difficult.

"Right about now, these doctors and pharmacies and local clinics ought to be alerted that this vaccine is imminent and expected to arrive," Dr. William Schaffner, an infectious diseases and health policy professor at Vanderbilt University School of Medicine told CNN.

Earlier Tuesday, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN's Jim Sciutto that it could be mid- to late-May or early-June before vaccines are widely available to the general population.

"I was hoping that that would be by the end of April," Fauci said. "That was predicated on J&J, the Johnson product, having considerably more doses than now we know they're going to have."

"So, that timeline will probably be prolonged,' Fauci said.

The moment is a critical one for President Biden, who stands to score a big win against the pandemic just weeks into his presidency. The vaccine could prove to be the great Covid-19 hope, as this one-dose shot doesn't call for the complicated deep-freeze technology that earlier vaccines required. It could also infuse the marketplace with millions of more doses suitable for younger, healthier people.

In a call with governors Tuesday, administration said it still anticipated the EUA on the J&J vaccine, but would only have a few million doses, according to a source on the call, and that officials might be able to provide a more specific number next week.

Many state officials have expressed optimism over the administration's willingness to have an open dialogue during the vaccine-distribution process, but sent a letter to the White House on Monday seeking better coordination between the federal government and states to prevent confusion and duplicative efforts.

One health industry source explained that as important as logistics are, there are also questions around another distribution challenge -- the efficacy of this vaccine.

Johnson & Johnson's vaccine was shown to be 66% effective overall in preventing moderate to severe disease 28 days after vaccination in a global Phase 3 trial, according to the company. The vaccine is, however, 85% effective overall at preventing severe disease and was 100% effective at preventing death in all regions where it was tested.

Hospitals are concerned over the public view of the J&J vaccine, and that patients will refuse to take one that has an efficacy of 66%, compared to the much higher efficacy of the Pfizer and Moderna vaccines.

What happens when a patient shows up and refuses to take the vaccine or demands a Pfizer/Moderna vaccine? Most providers do not want to be in charge of choosing who gets which vaccine, and are hoping for some sort of guidance from the administration or from states/jurisdictions on how to handle. An administration official told CNN the White House would not be getting ahead of the FDA's approval.

"We have plans to fold in any newly authorized vaccines into our distribution," a White House spokesperson told CNN. "FDA has independence to do its job and evaluate the safety and efficacy of this vaccine before we comment further."

The FDA could authorize the vaccine and then it is up to the US Centers for Disease Control and Prevention -- not the White House -- to ultimately issue any potential recommendations of that kind.

CDC director Rochelle Walensky said earlier this month that her agency's Advisory Committee on Immunization Practices will meet after the FDA approval of the J&J vaccine to offer potential public guidance on "how best to utilize" the various available vaccines based on preliminary data.

Schaffner, who sits on the CDC advisory committee said he was told to keep several days free after the FDA meets on the vaccine February 26.

A spokesperson from the agency confirmed this timeline and noted that the same protocols were followed with the distribution of both the Pfizer and Moderna vaccines.

Since no guidance has yet to be issued, some hospitals are already starting to have internal discussions around the equity and ethics of choosing who gets the vaccine with the lower efficacy. However, much of the conversation remains preliminary given the limited information about distribution.

According to this source, there are still complications with the Pfizer and Moderna vaccine distribution, hospitals scrambling after requesting one or the other based on their storage facilities and then receiving the wrong one. Given the kinks still in the existing system, the lack of information on the J&J distribution is causing concern among these providers.