Health officials across the U.S. are counting on the arrival of a second Covid-19 vaccine to boost scarce supplies and sidestep logistical issues encountered by the first vaccine, which began distribution this week.
The U.S. Food and Drug Administration may issue an emergency authorization for a vaccine from Moderna Inc. MRNA 5.09% as early as Friday after an advisory panel recommended the agency approve its use. If authorized, Moderna’s vaccine will join a vaccine from Pfizer Inc. PFE 0.50% and BioNTech SE BNTX 0.61% that received authorization on Dec. 11.
The green light would nearly double this month’s expected U.S. supply of Covid-19 vaccine doses and help meet a federal goal of getting a vaccine to anyone who wants one by the spring or summer of 2021. Moderna expects to add 20 million doses of its vaccine to Pfizer’s expected U.S. supply of 25 million in December.
“The addition of the Moderna vaccine to the response will be huge,” said Claire Hannan, executive director of the Association of Immunization Managers, whose members direct state vaccination efforts. Not only will the Moderna vaccine boost the supply of doses, but also it will “be much easier to send [it] to smaller providers and rural areas,” she said.
Moderna’s vaccine has easier storage and handling requirements and will be shipped in smaller quantities, health officials say. It can be stored in most standard medical freezers, while Pfizer’s must be shipped and kept at ultracold temperatures requiring either specialized freezers or dry ice, resources more common in large hospital systems and urban areas.
Once thawed, Moderna’s vaccine can be kept refrigerated for 30 days, while Pfizer’s can stay refrigerated for only five days after thawing.
Moderna’s vaccine also can be shipped in containers with as few as 100 doses, while Pfizer’s minimum order size is about 975 doses.
Pfizer’s larger minimum order size “poses challenges especially in rural areas of the country where that volume of product is more difficult to manage,” Anita Patel, deputy of the vaccine task force at the Centers for Disease Control and Prevention, said during an FDA advisory panel meeting on Dec. 10.
“This ultracold really, really makes it difficult to plan, based on the large quantity, and then also the ability of our partners to vaccinate during that time frame,” said Rich Lakin, immunization director for the Utah Department of Health. It is directing doses to hospitals, local health departments and pharmacies in the state.
Both vaccines are highly effective in preventing Covid-19 and use a similar gene-based technology. Pfizer’s vaccine was 95% effective at preventing disease in a study of 44,000 people, while Moderna’s was 94.1% effective in a 30,000-person study. Both vaccines were developed and tested at unprecedented speed.
Both vaccines also require people to come back three or four weeks later for a second dose. However, Moderna’s can be injected into people as is, while Pfizer’s has to be diluted in a separate solution before injection.
“Moderna definitely makes it easier from a logistics standpoint,” said Kristen Ehresmann, director of the infectious disease division with the Minnesota Department of Health. “It will help to fill in gaps for greater Minnesota, for the more rural parts of our state. Some areas of the state may not have access until the Moderna vaccine comes along.”
Federal and state officials said they have shaped their distribution strategies around the different features of the vaccines.
A Pfizer spokesman said the company’s supply-chain infrastructure is designed to ensure that people can get access to vaccine doses that meet its temperature requirements. A Moderna spokesman said the company has worked to improve the storage and shipping requirements for its vaccine, and stability testing this year has shown that it can be kept at higher temperatures.
A Covid-19 vaccine authorization would be Moderna’s first government clearance for a drug or vaccine in the 10 years since the company was formed to try to exploit an emerging gene-based technology. Anticipation of the Covid-19 vaccine has catapulted Moderna into the ranks of the most highly-valued drug companies, giving it a market capitalization of $54 billion.
The authorization would also validate the gene-based technology that Moderna has used to develop more than 20 other products for various diseases. FDA approval would signal that the technology could yield future vaccines and drugs using the same basic building blocks behind the Covid-19 vaccine.
Moderna and Pfizer are ramping up production, but so far the U.S. has committed to buying more of Moderna’s vaccine. On Dec. 11, the U.S. government agreed to double its purchase of Moderna’s vaccine to 200 million doses by the end of June. Pfizer has agreed to supply 100 million doses, though federal officials are in talks to secure additional doses, Secretary of Health and Human Services Alex Azar told reporters on Wednesday.
Initially, when supplies are limited, both vaccines are being reserved for health-care workers and residents of nursing homes and other long-term care facilities. As more doses become available, next in line are expected to be other essential workers, like police and teachers, senior citizens and people with underlying health conditions that put them at higher risk of severe Covid-19 disease.
Additional vaccines could also boost the mass immunization campaign if they prove successful in testing and are authorized for use.
Johnson & Johnson is testing a single-dose vaccine and expects to have results of a study of its vaccine in more than 40,000 people in January. That vaccine, unlike Pfizer’s and Moderna’s, wouldn’t require patients to take a second dose, and the company may seek U.S. authorization in February, if results are positive.
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