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Moderna, manufacturer of one of the three main COVID-19 vaccines being circulated in the U.S., said Thursday it's making new funding commitments to increase supply, which the company said will increase global supply of the vaccine to 3 billion doses by 2022.
That number is dependent on the mix between the authorized Moderna vaccine at a 100 μg dose level and potentially lower doses of its variant booster candidates and pediatric vaccines. Moderna will be using its cash balance to fund the investments.
The investments will allow for a doubling of drug substance manufacturing at a Switzerland-based facility, fill and finish manufacturing in Spain, and a 50% increase at Moderna's facilities in the U.S. When completed, the investments will also result in an increase in safety stock of raw materials and finished product that will be used to deliver these increased volumes.
Moderna will begin making investments at its owned and partnered manufacturing facilities in 2021, with increased production from these investments expected to ramp up in late 2021 and early 2022. The organization also raised its 2021 manufacturing supply forecast to between 800 million to 1 billion doses.
The increases are in addition to the recently announced increases in formulation, fill and finish in the U.S. with Catalent and Sanofi.
WHAT'S THE IMPACT
At its Vaccines Day presentation on April 14, Moderna said the investment in increased supply is necessary due to an expected, and significant, need for booster vaccinations in 2022 and beyond.
The company highlighted published studies predicting that waning immunity will impact vaccine efficacy within 12 months, and studies showing variants have lower starting neutralizing antibodies and may lead to breakthrough infections among those already infected or vaccinated -- compounding the potential need for variant boosters in the coming years.
Moderna also said during Vaccines Day that mRNA is the best-positioned technology platform to meet the global need for ongoing vaccinations.. This belief is based on the observations that mRNA vaccines have the highest published efficacy among authorized vaccines; the demonstrated ability of mRNA platforms to respond rapidly to the SARS-CoV-2 virus, including variants; and the capability for mRNA technology to produce multi-valent vaccines.
Moderna announced earlier this year that it is already testing a coronavirus variant vaccine and multivalent vaccine boosters in humans.
As Moderna gathers results from its ongoing variants clinical trials and more fully develops its booster product strategy, it will be in a position to better estimate supply ranges for 2022, which will be based, in large part, on product mix across single-dose boosters, primary (two-dose) vaccination series for adults, and primary (two-dose) series for the pediatric population, which may be at lower dose levels.
THE LARGER TREND
Vaccines are seen as the key to achieving herd immunity, which in turn is necessary to end the pandemic. Herd immunity is achieved when a critical mass of the population receives a vaccine, making virus transmission more difficult and slowing its spread.
A report released Thursday from RBC Capital Markets unearthed a suggestion for policymakers: Using morbidity and mortality as a proxy for reopening decisions could result in further suppression of the virus, and there could be a return to quasi-normalcy by June or July, even if true herd immunity isn't achieved until the fall.
But the spread of variants, skyrocketing cases in other countries and uneven vaccine uptake could lead to a winter resurgence, though it would pale next to the surge seen this past winter due to the millions of vaccinations that have been distributed.
RBC found that daily vaccination rates are beginning to slow, although 29.1% of the population has now been fully vaccinated and 42.7% have received at least one dose.