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President-elect Joe Biden plans to distribute available doses of COVID-19 vaccines when he comes into office on Jan. 20, in the latest proposal made by government officials in the U.S. and abroad as they work to speed up a slow and complicated vaccination rollout.
“He supports releasing available doses immediately and believes the government should stop holding back vaccine supply so we can get more shots in Americans’ arms now,” T.J. Ducklo, a spokesperson for Biden’s transition team, said in an email.
The Department of Health and Human Services had reportedly only distributed 45% of available vaccines in the U.S., as of Christmas Eve, according to a Dec. 24 op-ed written by a conservative columnist for The Washington Post.
Governors of eight states including California, Kansas, and New York sent a letter Friday to the government citing the op-ed and demanding “the federal government begin distributing these reserved doses to states immediately.”
There are currently two COVID-19 vaccines available in the U.S.: BioNTech SE BNTX, +7.15% and Pfizer Inc.’s PFE, +0.19% BNT162b2 and Moderna Inc.’s MRNA, -2.03% mRNA-1273. The vaccines, both of which are mRNA vaccines, require two doses, spaced a few weeks apart. (For BioNTech/Pfizer’s vaccine, that’s 21 days; for Moderna’s vaccine, it’s 28 days.)
In the month or so since both vaccines received emergency authorization from the Food and Drug Administration, the U.S. has missed its targets for vaccination. The Trump administration had called for 20 million people to be vaccinated in December, down from an original target of 100 million. As of Jan. 7, about 6 million people in the U.S., have received at least one dose of either vaccine, according to the Centers for Disease Control and Prevention.
In recent weeks, a series of new proposals in the European Union, the U.S., and the U.K. aim to change the dosing schedules of two-dose vaccines in a bid to speed up immunization. The suggestions come at a time when coronavirus case counts, hospitalizations, and deaths are surging. The U.S. on Thursday recorded more than 4,000 deaths in a single day from COVID-19.
- In the United Kingdom, health officials said they plan to push back the timeline for a second dose for people who get BioNTech and Pfizer’s or AstraZeneca AZN, +1.33% and the University of Oxford’s vaccine, which has not been authorized for use in the U.S. In this case, that means changing the window between doses from three weeks to 12 weeks.
- The U.K. also said it would allow a different vaccine to be substituted for the second dose if the original vaccine is out of stock at a particular site. “This option is preferred if the individual is likely to be at immediate high risk or is considered unlikely to attend again,” the government said last month.
- Dr. Moncef Slaoui, chief adviser to Operation Warp Speed, the Trump administration program in charge of funding COVID-19 treatments and vaccines, earlier this week suggested the U.S. give half-doses of Moderna’s vaccine to adults who are 55 years old or younger during a TV appearance.
- The European Medicines Agency said Friday that there are six doses, not five doses, available in each vial of the BioNTech-Pfizer vaccine, and recommended that the product information should be changed to reflect that. (The EMA, which is the E.U.’s drugs regulator, said health care providers should use low dead-volume syringes or needles to extract what it says is an extra dose.)
But not all regulators are on board. The FDA has raised concerns about altering dosing schedules that were established during the closely watched clinical-trial process for both mRNA vaccines.
Read: Slaoui proposes half-doses of Moderna’s COVID-19 vaccine to speed vaccinations
In a statement on Monday, FDA commissioner Dr. Stephen Hahn acknowledged that proposals to change dosing regimens to hasten immunizations are “reasonable” questions.
“We know that some of these discussions about changing the dosing schedule or dose are based on a belief that changing the dose or dosing schedule can help get more vaccine to the public faster,” he said. “However, making such changes that are not supported by adequate scientific evidence may ultimately be counterproductive to public health.”
At least one drugmaker that developed a COVID-19 vaccine has also expressed concern about proposed changes to dosing.
“Pfizer believes it is critical health authorities conduct surveillance efforts on any alternative schedules implemented and to ensure each recipient is afforded the maximum possible protection, which means immunization with two doses of the vaccine,” a spokesperson for the company told MarketWatch in December.
