The latest on COVID-19 vaccines/drugs and manufacturing from Pfizer, Catalent, Novavax, AstraZeneca, and Moderna. Highlights below. 

Manufacturing and supply of COVID-19 vaccines and drugs 
* Pfizer To Invest $120 M for US Mfg of Oral COVID-19 Drug  
* Catalent, MigVax Partner for Oral COVID-19 Vaccine 
Updates on COVID-19 therapeutics and vaccines 
* FDA Advisory Committee Recommends Novavax COVID-19 Vaccine 
* Moderna Reports Positive Results for Omicron COVID-19 Vaccine Booster 
* AstraZeneca Reports Phase II/III Outpatient Results for COVID-19 Drug 

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Manufacturing and supply of COVID-19 vaccines and drugs 

Pfizer To Invest $120 M for US Mfg of Oral COVID-19 Drug Mfg
Pfizer has announced a $120-million investment at its facility in Kalamazoo, Michigan, for production of its COVID-19 oral drug, Paxlovid (nirmatrelvir tablets and ritonavir tablets). 

The investment will expand the production of the active pharmaceutical ingredient (API) and registered starting materials used in the manufacture of nirmatrelvir, a protease inhibitor. The expansion will create more than 250 additional jobs at Pfizer’s Kalamazoo site. 

Paxlovid is approved or authorized for conditional or emergency use in more than 60 countries, including the US, to treat high-risk COVID-19 patients. To date (as of June 6, 2022), Pfizer has shipped 12 million treatment courses across 37 countries, including 5 million courses shipped to the US, and has manufactured almost 17 million treatment courses in total. 

Pfizer also plans to expand its modular aseptic processing sterile injectable pharmaceutical production facility in Kalamazoo as part of a second phase investment in the facility. The expansion adds to an initial investment of $450 million to build the 400,000-square-foot production facility. 

Source: Pfizer 

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Catalent, MigVax Partner for Oral COVID-19 Vaccine 
Catalent and MigVax, a Kiryat Shmona, Israel, a bio/pharmaceutical company developing an oral vaccine against COVID-19, have signed a development agreement under which Catalent will use its proprietary Zydis Bio orally disintegrating tablet (ODT) technology for delivering Migvax’s COVID vaccine, MigVax-101. 

Under the agreement, Catalent will undertake a feasibility study to formulate MigVax-101 into a ODT dose form and evaluate its preclinical performance and stability properties. Work will be carried out at Catalent’s 250,000-square-foot facility in Swindon, UK, which houses the company’s Zydis development and manufacturing operations. The facility produces over one billion ODTs annually. 

Source: Catalent 

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Updates on COVID-19 therapeutics and vaccines 

FDA Advisory Committee Recommends Novavax COVID-19 Vaccine 
An advisory committee of the US Food and Drug Administration (FDA) has recommended Novavax’s COVID vaccine for emergency use authorization (EUA) for individuals aged 18 years or older. Novavax is a Gaithersburg, Maryland-based vaccine company. 

The FDA considers the recommendations of advisory committees, in this case, the Vaccines and Related Biological Products Advisory Committee, when making decisions on EUA. 

Novavax’s COVID-19 vaccine has received authorization for use in individuals aged 18 and over in more than 40 countries in addition to Emergency Use Listing from the World Health Organization.   

Source: Novavax 

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Moderna Reports Positive Data for Omicron COVID-19 Vaccine Booster 
Moderna reported positive Phase II/III results for its bivalent COVID-19 vaccine booster candidate for the Omicron variant, mRNA-1273.214, which consists of Moderna’s COVID-19 vaccine, Spikevax, and a vaccine candidate that targets the Omicron variant. 

The 50-microgram bivalent booster generated a stronger antibody response against Omicron than the original Moderna vaccine, Spikevax. The company reported an eight-fold boost in neutralizing geometric mean titers against Omicron among baseline seronegative participants. The booster dose of mRNA-1273.214 was generally well-tolerated, with side effects comparable to a 50-µg booster dose of Spixevax. 

mRNA-1273.214 is Moderna’s lead candidate for a fall 2022 booster for the Omicron variant. Moderna plans regulatory submission in the coming weeks (as reported on June 8, 2022) to enable use of mRNA-1273.214 for a fall booster. 

Source: Moderna 

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AstraZeneca Reports Phase III Outpatient Results for COVID-19 Drug 
AstraZeneca reported positive Phase III results of Evusheld (tixagevimab and cilgavimab), its COVID-19 drug, as an outpatient treatment for mild-to-moderate COVID-19. Evusheld is a combination of two long-acting antibodies, tixagevimab and cilgavimab, derived from B-cells donated by individuals previously infected with the SARS-CoV-2 virus, the virus that causes COVID-19. It was discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in 2020. 

Specifically, the company reported that the drug showed protection against progression to severe COVID-19 or death from any cause compared to placebo, with treatment with Evusheld earlier in the disease course leading to more favorable outcomes. 

Evusheld has marketing authorization in the European Union and was granted conditional marketing authorization by the UK’s Medicines and Healthcare products Regulatory Agency for pre-exposure prophylaxis of COVID-19. It is authorized for emergency use for pre-exposure prophylaxis of COVID-19 in the US. It is also authorized for use and being supplied in several other countries, and regulatory filings for prevention and treatment of the drug are progressing globally.  

Source: AstraZeneca