- The Washington Times
Thursday, September 16, 2021

The COVID-19 vaccine from Pfizer and BioNTech was the first to reach American arms, and it accounts for more than half of the 380 million doses administered in the U.S. so far.

The shot has another advantage as the nation hurtles into a period in which workers must either get vaccinated or lose their jobs: It’s the only vaccine fully licensed by the Food and Drug Administration, lending it preferred status as President Biden says regulatory approval should reassure holdouts.

Mr. Biden didn’t tell Americans which version to take in a speech outlining his plan to mandate COVID-19 vaccines at large companies, but he pointed to FDA approval as a key reason. Indeed, employers and the Defense Department have pointed to the licensure of at least one COVID-19 vaccine as the fulcrum of their decisions to require vaccination.

“There’s no question that a great deal of hesitancy has come from the perception of experimental vaccines, not yet fully approved and lacking research into their long-term effects. Pfizer should have a comparative advantage in the public eye until the other vaccine makers earn full approval,” said Michael Bars, a senior communications adviser in the Trump White House.

Adding complexity, Pfizer is in the most favorable position for booster shots after eight months of initial vaccines.

The FDA and the Centers for Disease Control and Prevention are vetting an application from Pfizer to offer a third dose. The agencies could grant approval to Pfizer in the coming days as they continue to analyze booster data from Moderna.

FDA advisers will discuss Pfizer’s request on Friday. The CDC Advisory Committee on Immunization Practices will convene next week to discuss whether the general population should be eligible for a third Pfizer shot or whether boosters should be tailored to health care workers, the elderly and the medically frail.

Still, analysts don’t expect Mr. Biden to speak on behalf of Pfizer. His team spent months saying a similar vaccine from Moderna and a one-shot option from Johnson & Johnson were highly effective against COVID-19.

“Why the ecumenical attitude? First off, they don’t want to tell Americans who received one up until now they have to be revaccinated. Second, J&J, with its one-dose regimen, for example, has been preferred by some communities. And when people are hard to reach or mildly vaccine skeptical, the ability to provide only one, not two, doses may be a big plus,” said I. Glenn Cohen, a health care expert at Harvard Law School.

He said emerging data suggests the vaccines perform differently for fighting the delta variant or maintaining immune responses. “So we may reach a point where the administration will more strongly endorse one over the other. But at the moment, I don’t see them going there, and I think it would take a lot for them to get to that point,” he said.

Tracey Diamond, a partner at Troutman Pepper law firm specializing in employment law, said companies have a practical interest in letting their workers choose from all the versions.

“Allowing employees a choice is best in case an employee has concerns about a particular vaccine because of any specific contraindications or religious concerns,” she said.

The Pfizer vaccine accounts for 57% of the roughly 380 million shots that have been administered in the U.S. Moderna comprises 39%, and 4% have been from J&J. The breakdown is relatively unchanged from Aug. 23, the day FDA regulators fully approved the Pfizer vaccine, suggesting licensure hasn’t produced a massive shift in preferences.

Unlike the initial rollout, when officials told Americans to take whatever shot they could get, the vaccines now are plentiful and consumers can be choosy.

Pfizer told The Washington Times that it has been manufacturing at full capacity, regardless of mandates, to satisfy the U.S. and global demand and meet its projection of producing 3 billion doses in 2021. The company, with partner BioNTech, said it will deliver on all of its commitments.

“At Pfizer, we are aware that to put an end to this pandemic, we need multiple vaccines and treatments from multiple sources. Following the science, we are doing all that we can to stay ahead of COVID-19,” the company said in a written statement. “We also continue to enhance and expand our manufacturing network so that we can continue to produce doses at full capacity for people all over the world.”

The FDA authorized Pfizer’s vaccine for emergency use under the Trump administration on Dec. 11, a week before Moderna received the same type of permission to distribute its vaccine. Both versions require two doses and use the messenger-RNA technology that teaches the body to recognize and fight the coronavirus.

Regulators authorized the J&J vaccine, which uses an inactivated virus, for emergency use in late February.

Pfizer, based in New York City, was the first to receive full federal approval. Moderna, based in Massachusetts, completed its application for full approval on Aug. 25. J&J hasn’t applied for full approval.

The confluence of mixed approval status and Mr. Biden‘s mandates “may lead to friction because the other manufacturers will say, ‘We’re not fully licensed yet, but we’re very good,’” said Arthur Caplan, director of the division of medical ethics at the New York University Grossman School of Medicine.

Moderna declined to comment on whether it would perceive the disparity in FDA approval status as a problem as Mr. Biden deploys his mandates and an increasing number of employers require vaccines.

J&J did not respond to a request for comment on its timeline for requesting full approval or whether Pfizer might have an advantage in the mandate era.

Maintaining faith in all three vaccines while highlighting 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’ll say: ‘Discuss it with your doctor.’ That’s the out,” Mr. Caplan said. “They’ll bob and weave a bit about what an individual, who now faces a mandate, chooses as the quote-unquote vaccine of choice.”

Mr. Biden offered broad support to all the vaccines in a White House speech last week detailing his six-step plan to combat the delta variant. He said the vaccines are effective at staving off disease and highlighted the FDA approval without specifying which company secured it.

“Of the nearly 80 million eligible Americans who have not gotten vaccinated, many said they were waiting for approval from the Food and Drug Administration — the FDA. Well, last month, the FDA granted that approval,” he said. “So, the time for waiting is over.”

The government has experience in mandating a licensed vaccine while allowing Americans to look for another version.

“Mandatory vaccination against COVID-19 will only use COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA), in accordance with FDA-approved labeling and guidance,” Defense Secretary Lloyd Austin wrote in mandating COVID-19 vaccination for U.S. troops after the Pfizer approval in August.

However, he said service members who get, or already have received, a vaccine that qualifies for emergency use from the FDA or World Health Organization will satisfy the mandate.

Copyright © 2021 The Washington Times, LLC.