Moderna Ups COVID-19 Vaccine Manufacturing Estimate to 600M in 2021

Moderna recently released a COVID-19 vaccine manufacturing update for its mRNA-based vaccine, mRNA-1273. The company announced that it is increasing its base-case global production estimate from 500 to 600 million doses for 2021. 

The company hopes to build that estimate to 1 billion doses by the end of 2021 based on continued investments and the addition of more staff.

Nearly 100 million of those doses to be available in the US by the end of the first quarter of 2021, with 200 million doses total available by the end of the second quarter. 

“Our effectiveness in providing early supply to the U.S. and Canadian governments and our ability to increase baseline production estimates for 2021 are both signals that our scale-up of mRNA vaccine production is a success,” Juan Andres, chief technical operations and quality officer at Moderna, said in the announcement.  

“I want to thank the many private and government collaborators, contractors and the hundreds of Moderna staff who have been working thoughtfully and tirelessly to accomplish this,” Andres continued. 

Last month, a second primary analysis of mRNA-1273 found a 94.1 percent vaccine efficiency against the coronavirus. 

The Phase 3 study, COVE, has enrolled over 30,000 participants in the US and is based on the analysis of COVID-19 cases confirmed and adjudicated two weeks after the second dose of a vaccine. 

Vaccine efficiency was observed in a total of 196 cases, of which 185 were in the placebo group and 11 were in the mRNA-1273 group.

Due to the positive trial results, Moderna has developed distribution plans alongside drug development in order to get an approved vaccine into the hands of providers as soon as possible.

In mid-August, for example, HHS and the Department of Defense (DoD) announced an agreement with Moderna for large-scale production and nationwide delivery of 100 million doses of mRNA-1273 in the US.

Under the agreement, Moderna will manufacture the vaccine doses while clinical trials are underway. The federal government will own the doses and will be able to acquire up to an additional 400 million doses of mRNA-1273.

The HHS-Moderna agreement also includes fill-finish manufacturing in US-based facilities, which ensures vaccine doses are packaged and ready to ship immediately once the vaccine showed success in clinical trials, HHS said. 

mRNA-1273 would also be available to US citizens at no cost, although providers would be able to charge for the administration of the vaccine, according to the agreement. 

Just weeks later, the Trump Administration, through HHS and the DoD, announced that it will purchase an additional 100 million doses of mRNA-1273. 

The vaccine received FDA emergency use authorization at the end of December and Moderna began supplying to the government shortly thereafter.

Along with the US, Moderna recently announced that the Canadian Government will now acquire an additional 20 million doses of the COVID-19 vaccine, bringing the total to 40 million doses. 

The updated agreement comes three months after Canada increased its initial commitment of the vaccine candidate to 20 million. 

The Swiss Federal Government has also increased its confirmed order commitment from 4.5 million to 7.5 million doses of mRNA-1273.

Both mRNA-1273 and Pfizer’s leading mRNA COVID-19 vaccine candidate, BNT162b2, are pulling ahead in the vaccine race.

Although both candidates were over 90 percent effective in clinical trials, there were few minor differences in the clinical trials and major variances in the storage of each candidate. 

For example, Moderna’s vaccine can be stored at 36 to 46 degrees Fahrenheit and can last nearly 30 days in the fridge. Specifically, mRNA-1273 can remain stable at four degrees Fahrenheit for nearly six months at refrigerated conditions for up to 30 days and at room temperature for up to 12 hours.

In contrast, Pfizer’s product must be at -112 degrees Fahrenheit to remain effective. This temperature requires special freezers usually found in research labs and hospitals.