Alex Azar, refusing to acknowledge election results, says they're not working with Biden team on vaccine rollout
With data now out on two experimental vaccines, the course of the raging US outbreak and the success of the federal government’s $18 billion vaccine acceleration program hinges in part on whether officials can successfully roll doses out to the general public, should they receive FDA authorization.
It’s a delicate and highly technical process, one that officials have been game-planning in military tabletop style for months. But so far neither those officials nor other representatives from the federal government have spoken to the administration that will take over just a month into the likely rollout, HHS secretary Alex Azar said Wednesday.
Refusing to acknowledge the outcome of the November election, Azar said his agency would not work with president-elect Joe Biden’s team until the General Services Administration issues a letter kick-starting the process. He said, however, that the rollout is being carried out by career officials, ensuring continuity.
“In the event of a transition, all of the individuals you see here besides myself, all of the people involved in planning at CDC and on the Operation Warp Speed team, these are career officials, so they’re not impacted by any change in leadership,” he said at a press conference beside Warp Speed leaders Moncef Slaoui and General Gustave Perna. “In the event of transition, there’s really just total continuity.”
While outside experts raise red flags over how well cash-strapped states will be able to handle a mass vaccination campaign, Azar, Slaoui and Perna tried to project confidence that officials were prepared and the rollout would go smoothly.
Others in and around the government, though, have been less sanguine. Pfizer CEO Albert Bourla said this week that he believed distribution would be more orderly than some anticipate, but said the state of the presidential transition was not “ideal.” Anthony Fauci raised concerns on Monday that a rough transition between Trump and Biden’s administration could disrupt the rollout.
“We want a smooth process for that,” Fauci said on the Today Show. “And the way you do that is by essentially having the two groups speak to each other and exchange information.”
Unlike the White House, executives at the leading companies developing Covid-19 vaccines have provided updates to Biden’s team on their progress. CNN reported that HHS staffers have been instructed that should a member of Biden’s team reach out to them, they should contact the deputy surgeon general of communication and not respond.
Slaoui, Warp Speed’s scientific head, said at the press conference that he expected an EUA for both Pfizer and Moderna’s vaccine to come in the middle of December, an estimate in line with company predictions and outside reporting. He said data from an unnamed third vaccine — likely a reference to the candidate from AstraZeneca and Oxford — could follow in a few weeks.
Should one or both be authorized, the federal government will immediately distribute some doses to all 64 jurisdictions it oversees, Perna said.
“Upon receipt of emergency use authorization, all of America must receive vaccine within 24 hours,” he said. “I think this incredibly important — fair and equitable distribution of vaccine throughout the country. There is no have and have nots.”
The government expects to ship 40 million doses of vaccine in December, enough to inoculate 20 million people. States have asked for $8 billion in aid to handle those shipments and get them into arms, but Congress has not approved new funding and Azar has repeatedly rebuffed the requests.
Pfizer and Moderna’s vaccine have different requirements for cold-chain storage and precisely where each vaccine goes and who should get it will come down to decisions from the CDC’s Advisory Committee on Immunization Practices.
Normally that committee meets directly after an approval is issued, but Azar said he is trying to have them meet at the same time the FDA advisory committee meets. In September, the ACIP raised serious concerns about the challenges that the rollout of the Pfizer-BioNTech vaccine would pose.
“The complexities of this plan for vaccine storage and handling will have major impact in our ability to efficiently deliver the vaccine,” Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, said at the time.
The Pfizer-BioNTech mRNA candidate needs to be stored and shipped at -94 degrees Fahrenheit and can only be kept at normal fridge temperatures for up to 7 days. Pfizer and the government say the “thermal shippers” they developed should mitigate concerns. Moderna’s vaccine can be shipped at -4 degrees and stored in the fridge for up to a month.
Slaoui acknowledged that regulators would only have a couple months follow-up on the first two vaccines when they are likely authorized, but he laid out in stark terms what he saw as the cost of waiting now that the virus is surging to record levels across the country.
Around 70% of the country, he said, would likely have to be immunized to achieve herd immunity.
“We have north of 150,000 people infected every day and north of 1,000 people dying everyday,” he said at a press conference. “And waiting 2 more months or 4 more months will count in the tens or hundreds of thousands of more deaths the harm to the population that no vaccine would ever even approach.”
He said, however, that they will still collect data on the vaccines after the EUA. That includes short- and long-term safety monitoring, but also data on how durable the vaccines are and how well they prevent asymptomatic infection. Slaoui predicted the data will show some but not complete protection.
It’s unclear when Moderna or Pfizer will unblind the studies, but Slaoui said the latest it would come is 2 to 3 months after the EUA, when he predicted the FDA would formally approve both vaccines.
Still, he said, the US would need more vaccines to cover the population and he urged more Americans to sign up for on-going and forthcoming trials on the next wave of candidates. It would not only help the world get answers faster, he said, but also give you 50/50 odds of getting a vaccine tomorrow instead of in several months.
“We now know that vaccination is possible — not only it’s possible, it’s incredibly effective. It’s very likely that other vaccines will also be as effective,” he said. “Come and participate.”
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