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Moderna and Pfizer's COVID-19 vaccine candidates require ultra-low temperatures, raising questions about storage, distribution

By Jaimy Lee

The storage requirements for mRNA vaccines for COVID-19 'would make traditional office or pharmacy administration very difficult,' one Wall Street analyst said

The COVID-19 vaccine candidates being developed by Moderna Inc. and BioNTech and Pfizer Inc. will require stringent standards for refrigeration, and that may hamper how they are distributed to the hundreds of millions of Americans expecting to receive them.

Shares of Moderna (MRNA) fell 3.5% in trading on Thursday, following a rally on Wednesday after the company's disclosure (link) that people older than 55 years old who participated in the Phase 1 trial had demonstrated neutralizing antibody titers. Pfizer's (PFE) stock was down 0.5% in Thursday trading, while BioNTech (BNTX) tumbled 3.4%.

Read:Global case tally tops 24 million, U.S. tally above 5.8 million and CDC walks back change to testing guidance (link)

Executives from Moderna and Pfizer on Wednesday separately told the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practice on Wednesday that mRNA-1273, which is Moderna's coronavirus vaccine candidate, requires a storage temperature of negative 4 degrees Fahrenheit. BioNTech and Pfizer's candidates, BN1162b2 and BNT162b2, need to be stored in negative 94 degrees Fahrenheit.

"These storage conditions would make traditional office or pharmacy administration very difficult," SVB Leerink analysts wrote in a note to investors on Thursday. "These conditions could be met at tertiary hospitals and laboratories and could be accommodated in intensive one-day vaccination events at such sites, but this would still only cover a fraction of the healthy population."

See also:Moderna's stock rises after it says COVID-19 vaccine candidate produced antibodies in older patients (link)

Officials at the Centers for Disease Control and Prevention said they are aware of the issue.

Dr. Kathleen Dooling, a medical officer for the agency's division of viral diseases, said (link) Wednesday that storage, distribution, and handling requirements of these vaccines "will make it very difficult for community clinics and local pharmacies to store and administer." She also noted that most vaccines will have to be "administered at centralized sites with adequate equipment and high throughput."

Pfizer will need to use ultralow temperature freezers and thermal shipper storage for its COVID-19 vaccine candidates, according to comments made by Dr. Nicholas Kitchin, senior director of Pfizer's vaccine clinical research and development group.

The vaccines being developed by Moderna, BioNTech, and Pfizer are mRNA vaccines; however, other types of vaccines require less intense rules around storage. Concern about the difficulties of storing and shipping mMRNA COVID-19 vaccines to hundreds of millions of people could put the makers of these candidates at a competitive disadvantage, analysts say. It may also separate Moderna's vaccine from the ones being developed by BioNTech and Pfizer.

Read: This Seattle man volunteered to be injected with an experimental COVID-19 vaccine: 'It was kind of my duty as a healthy individual to step up' (link)

There are about half a dozen COVID-19 vaccine candidates in clinical trials in the U.S. However, not all of them are mRNA vaccines. The vaccine being developed by AstraZeneca (AZN.LN) (AZN.LN) and the University of Oxford is a recombinant viral vector vaccine, for example, while Inovio Pharmaceutical Inc.'s (INO) candidate is DNA-based.

"Investors are increasingly looking to storage and delivery conditions across vaccine candidates as they consider competitive positioning," SVB Leerink's Mani Faroohor said in a separate note to investors.

Since the start of the year, Moderna's stock has soared 244.5%, shares of BioNTech have gained 91.9%, and Pfizer's stock is down 3.3%. The S&P 500 is up 7.7% for the year.

-Jaimy Lee; 415-439-6400;


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08-31-20 0656ET

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