Moderna has announced new investments from Europe and the US to increase global vaccine supply, expecting to increase 2022 capacity to up to 3 billion doses of its COVID-19 vaccine. The announcement was followed by the World Health Organization’s (WHO) decision to list the Moderna vaccine for emergency use, making it the fifth vaccine to receive emergency validation from WHO. 

“As we follow the rapid spread of SARS-CoV-2 variants of concern, we believe that there will continue to be significant need for our mRNA COVID-19 vaccine and our variant booster candidates into 2022 and  2023,” said Stéphane Bancel, Chief  Executive Officer of Moderna.

The vaccine manufacturer highlighted studies that predicted waning immunity will impact vaccine efficacy within 12 months, compounding the need for variant boosters in the coming years. 

Though many agreed that variant boosters will be necessary in the future, governments were concerned about the ability to scale up production. “We are hearing from governments that there is no technology that provides the high efficacy of mRNA vaccines and the speed necessary to adapt to variants while allowing reliable scalability of manufacturing.”

But with these investments, Moderna now has the capability to scale up drug manufacturing at the company’s Switzerland and Spain-based facilities. There will also be a 50% increase of drug substances at Moderna’s facilities in the US. 

Increased Shelf-Life for Vaccines

Moderna also announced that ongoing development data related to its current COVID-19 vaccine formula could support a three-month refrigerated (2-8 degrees Celsius) shelf life in alternate formats that make it easier to distribute, such as the doctor’s office or other small settings. 

Current vaccine supply is approved for storage up to one month at refrigerated temperatures (2-8 degrees Celsius) and up to seven months in a standard freezer (-20 degrees Celsius). Moderna’s vaccine is the only authorized mRNA vaccine that does not require on-site dilution. 

The company is also working on new formulas of its COVID mRNA-1273 vaccine and a next generation of the vaccine that will extend refrigerated shelf life longer. 

Variant and Vaccine Booster Tests Underway

The company is raising its 2021 supply forecast to between 800 million to 1 billion doses, with production from investments expected to ramp up in later this year early 2022. 

Earlier this year it announced that it is already testing the SARS-CoV-2 variant vaccine and multivalent vaccine boosters in humans. 

Results from its ongoing variant clinical trials and develops its booster shot strategy will place Moderna in a position to better estimate the supply ranges for 2022, which will be based on product mix across single-dose boosters, primary (two-dose) vaccinations for adults, and primary (two-doses) shots for children, which may be at lower dose levels. 

The scaled-up production and manufacturing capabilities come after last week’s forum sponsored by the International Pharmaceutical Manufacturers and Associations (IFPMA).  

Bancel, at the press briefing, had said that the company is “in the final stretch to get an agreement with COVAX” for its vaccine. 

Pfizer CEO Announces COVID-19 Oral Drug Could Be Available at the End of 2021

Pfizer’s experimental oral drug for treating COVID-19 could be available at the end of 2021,  CEO Albert Bourla told CNBC on Tuesday.  

“If clinical trials go well and the Food and Drug Administration approves it, the drug could be distributed across the U.S. by the end of the year,” Bourla told CNBC. 

Pfizer, which developed the first authorized COVID-19 vaccine in the US with German drugmaker BioNTech, began an early-stage clinical trial in March testing new antiviral therapy for coronavirus. In addition to the drug, Pfizer is testing its vaccine in 6-month to 11-year-old children. 

Earlier this month, the company asked the Food and Drug Administration (FDA) to expand its vaccine authorization to adolescents ages 12 to 15 after the shot was found to be 100% in a study, with no serious side effects. 

Bourla also told CNBC that the company is ‘comfortable’ in producing at least 2.5 billion vaccine doses for 2021, noting how Pfizer had overcome the original ‘forecasted losses’. 

“We made tremendous progress in improving processes, in building the infrastructure at the speed of light and in resolving issues with third-party supplies,” he added.

Bourla noted that the ‘horrible situation’ in India and the rest of the world, where the rate of vaccinations and availability of vaccines is lower, needed to be addressed, and saw this as an ‘ethically unacceptable issue’.

“If we are not able to provide services for India or Africa, they will become a pool where the virus will replicate and generate variants.” 

India is currently facing a catastrophic second wave that accounts for 38% of global cases reported in the past week, according to the WHO. 

Image Credits: Jernej Furman/Flickr, WEF, CNBC.