Biden is careful not to play favorites, but Pfizer enjoys ‘comparative advantage’ in mandate era
Pfizer and BioNTech’s COVID-19 vaccine was the first to reach US guns, and it accounts for more than half of the 380 million doses administered in the United States so far.
The coup has another advantage as the nation rushes into a period in which workers must either get vaccinated or lose their jobs: it is the only vaccine fully licensed by the Food and Drug Administration, which it confers privileged status as President Biden says regulatory approval should reassure dissenters.
Mr Biden did not tell Americans which version to take in a speech outlining his plan to impose COVID-19 vaccines on big business, but he pointed to FDA approval as a main reason. Indeed, employers and the Department of Defense have indicated that the approval of at least one COVID-19 vaccine was the basis for their decisions to require vaccination.
“There is no doubt that a great reluctance has come from the perception of experimental vaccines, not yet fully approved and lacking research into their long-term effects. Pfizer is expected to have a comparative advantage in the public eye until other vaccine makers get full approval, ”said Michael Bars, senior White House communications adviser to Trump.
Adding to the complexity, Pfizer is in the most favorable position for booster injections after eight months of initial vaccines.
The FDA and the Centers for Disease Control and Prevention are reviewing a request from Pfizer to offer a third dose. Agencies may grant approval to Pfizer in the coming days as they continue to analyze Moderna recall data.
FDA advisers will discuss Pfizer’s request on Friday. The CDC’s Advisory Committee on Immunization Practices will meet next week to determine whether the general population should be eligible for a third Pfizer vaccine or whether boosters should be suitable for healthcare workers, the elderly and the medically fragile. .
Still, analysts don’t expect Mr. Biden to speak for Pfizer. His team spent months saying that a similar vaccine from Moderna and a one-shot option from Johnson & Johnson was very effective against COVID-19.
“Why the ecumenical attitude? First of all, they don’t want to tell Americans who have received one so far that they need to be revaccinated. Second, J&J, with its single dose regimen, for example, has been preferred by some communities. And when people are hard to reach or mildly skeptical of vaccines, the ability to provide just one dose, not two, can be a big plus, ”said I. Glenn Cohen, expert in vaccines. health care at Harvard Law School.
He said emerging data suggests vaccines work differently to fight the delta variant or maintain immune responses. “So we can reach a point where the the administration will approve more strongly over each other. But at the moment I don’t see them going, and I think it would take a long time for them to get there, ”he said.
Tracey Diamond, a partner at labor law firm Troutman Pepper, said companies have a practical interest in letting their employees choose from all the versions.
“It’s best to leave the choice to the employees in case an employee has concerns about a particular vaccine due to specific contraindications or religious concerns,” she said.
The Pfizer vaccine represents 57% of the approximately 380 million vaccines administered in the United States. Moderna includes 39% and 4% came from J&J. The split is relatively unchanged from August 23, the day FDA regulators fully approved the Pfizer vaccine, suggesting that authorization to exercise did not result in a massive change in preferences.
Unlike the initial rollout, when officials told Americans to take every injection possible, vaccines are now plentiful and consumers can be picky.
Pfizer told the Washington Times that it was producing at full capacity, regardless of mandates, to meet US and global demand and meet its production forecast of 3 billion doses in 2021. The company, along with its partner BioNTech, said she would deliver all of her pledges.
“At Pfizer, we understand that to end this pandemic we need multiple vaccines and treatments from multiple sources. By following the science, we are doing all we can to stay ahead of COVID-19, ”the company said in a written statement. “We also continue to improve and expand our manufacturing network so that we can continue to produce doses at full capacity for people around the world. “
The FDA cleared Pfizer’s vaccine for emergency use under the Trump administration on December 11, a week before Moderna received the same type of clearance to distribute its vaccine. Both versions require two doses and use messenger RNA technology that teaches the body to recognize and fight the coronavirus.
Regulators cleared the J&J vaccine, which uses an inactivated virus, for emergency use in late February.
New York-based Pfizer was the first to receive full federal approval. Massachusetts-based Moderna completed her application for full approval on August 25. J&J did not seek full approval.
The confluence of mixed approval status and Mr. Biden’s tenures “can lead to friction as other manufacturers will say, ‘We’re not fully licensed yet, but we’re very good,'” said Arthur Caplan, director. in the division of medical ethics at the Grossman School of Medicine at New York University.
Moderna declined to say whether she would perceive the disparity in FDA approval status as an issue as Mr. Biden rolls out his mandates and a growing number of employers demand vaccines.
J&J did not respond to a request for comment on its timeline to seek full approval or whether Pfizer might have an advantage in the Mandate Age.
Maintaining faith in all three vaccines while emphasizing the benefits of FDA approval will be a balancing act for White House messengers.
“They don’t want to be accused of practicing medicine. I know what they will say, “Talk to your doctor. This is the exit, ”Mr. Caplan said. “They’re going to wrestle and weave a bit into what an individual, who now faces a warrant, chooses as the vaccine of choice in quotes.”
Mr Biden offered broad support for all vaccines in a White House speech last week detailing his six-step plan to tackle the delta variant. He said the vaccines were effective in warding off the disease and pointed to the FDA approval without specifying which company had obtained it.
“Of the nearly 80 million eligible Americans who have not been vaccinated, many have said they are awaiting approval from the Food and Drug Administration – the FDA. Well, last month the FDA gave that approval, ”he said. “So the time to wait is over. “
The government has experience with requiring a licensed vaccine while still allowing Americans to research another version.
“Mandatory COVID-19 vaccination will only use COVID-19 vaccines that receive a full license from the Food and Drug Administration (FDA), in accordance with FDA approved labeling and guidelines,” wrote the Secretary of Defense Lloyd Austin in making COVID-19 vaccination mandatory. for US troops after Pfizer’s approval in August.
However, he said military personnel who are receiving, or have already received, a vaccine that can be used urgently by the FDA or the World Health Organization will meet the mandate.