COVID News: Moderna, AstraZeneca, Endo, Pfizer & More

The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Moderna, AstraZeneca, Endo International, Pfizer, Regeneron, Celltrion, Novavax, Daiichi Sankyo, and the FDA.

Manufacturing and supply of COVID-19 vaccines and drugs

Moderna, EU To Donate 70 M+ Doses of COVID-19 Vaccine
Moderna has announced an agreement that enables countries of the European Union (EU) and European Economic Area (EEA) to donate doses of Moderna’s COVID-19 vaccine that they have purchased under the EU Vaccines Strategy to COVAX, a global partnership for equitable vaccine access, on an ongoing basis for delivery in 2021.

This initiative, led by France, Sweden, and Norway is expected to enable the donation of more than 70 million doses of Moderna’s vaccine in 2021, including an initial donation of 15 million doses by France and 40 million doses by Germany.

Separately, Moderna has submitted for authorization with Health Canada for the evaluation of a 50-µg two-dose series of its COVID-19 vaccine in children ages 6 to 11 years. Health Canada has already authorized the use of a booster dose of Spikevax at the 50-µg dose for individuals aged 18 and older administered at least six months after completion of the primary series.

Source: Moderna (supply), Moderna (Canada filing), and Moderna (booster dose)

AstraZeneca Gives Supply Update for COVID-19 Vaccine
AstraZeneca and its partners have released supply for two billion doses of AstraZeneca’s COVID-19 vaccine to more than 170 countries globally in the last 11 months.

Approximately two-thirds of these have gone to low- and lower-middle-income countries, including more than 175 million doses delivered to 130 countries through the COVAX Facility, a global initiative for equitable for COVID-19 vaccines and treatments.

This milestone comes 18 months after AstraZeneca and Oxford University formed their partnership for the global development and distribution of a not-for-profit COVID-19 vaccine, and less than 12 months after its first emergency authorization in the UK.

Source: AstraZeneca

Endo in $90-M Fill–Finish Mfg Pact with US Gov’t
Endo International, a generics and specialty branded pharmaceuticals company, has entered into a $90-million agreement with the US government to expand its sterile fill–finish manufacturing production capacity and capabilities at its Rochester, Michigan plant to support the US government’s efforts for production of critical medicines advancing pandemic preparation.

Under the agreement the Rochester facility will establish a new sterile fill–finish manufacturing asset capable of processing liquid or lyophilized products requiring Biosafety Level 2 containment and will also provide expanded product inspection and packaging capacity to the US government. The US government will fund approximately $90 million of the program’s total expected cost of approximately $120 million.

Source: Endo International

Pfizer/BioNTech To Supply COVID-19 Vaccine in Ghana

Pfizer and BioNTech have entered into a supply agreement with Zipline, a logistics company, to provide distribution of approximately 50,000 of Pfizer’s/BioNTech’s COVID-19 vaccine in Ghana, using long-range drone delivery for mRNA COVID-19 vaccines requiring ultra-cold-chain, a new model for vaccine distribution.

Pfizer, BioNTech, and Zipline tested and validated the end-to-end model for delivery of mRNA vaccines with ultra-cold-chain requirements, and Zipline says it will now use it to distribute Pfizer’s/BioNTech’s COVID-19 vaccines, as well as COVID-19 vaccines from all manufacturers, to regions across Ghana.

Source: Pfizer, BioNTech, and Zipline

Updates on COVID-19 treatments and vaccines

EU OKs Regeneron’s COVID-19 Antibody Cocktail
The European Commission (EC) has approved the casirivimab and imdevimab antibody cocktail from Regeneron Pharmaceuticals, a Tarrytown, New York-based bio/pharmaceutical company, for people aged 12 years and older for treating non-hospitalized patients with confirmed COVID-19 who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19, and to prevent COVID-19. The antibody cocktail is known as REGEN-COV in the US and Ronapreve in the European Union (EU) and other countries,

Regeneron invented the antibody cocktail and is collaborating with Roche, who is primarily responsible for development and distribution outside the US. In addition to this marketing authorization application, the companies intend to submit a future Type II variation to the European Medicines Agency that seeks to expand the indication to include the treatment of patients hospitalized because of COVID-19.

Last month (October 2021), the US Food and Drug Administration (FDA) accepted for priority review the first of two biologics license applications (BLAs) for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The second BLA submission will focus on those hospitalized because of COVID-19 and is expected to be completed later this year (as reported on November 12, 2021).

Emergency or temporary pandemic use authorizations are currently in place in more than 40 countries, including the US, India, Switzerland and Canada, and the antibody cocktail is fully approved in Japan and conditionally approved in the UK and Australia. In the US, REGEN-COV has not been approved by the FDA, but is currently authorized under an emergency use authorization for use in certain post-exposure prophylaxis settings and as a treatment for people with mild-to-moderate COVID-19 who are at high risk of serious consequences from COVID-19.

Source: Regeneron

EU OKs Celltrion’s COVID-19 Drug
The European Commission (EC) has granted marketing authorization for Regkirona (regdanvimab) from Celltrion, an Incheon, South Korea-based bio/pharmaceutical company, for treating adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

Emergency use authorizations are currently in place in Indonesia and Brazil, and the monoclonal antibody treatment is fully approved in the Republic of Korea. In the US, regdanvimab has not yet been approved by the Food and Drug Administration (FDA), but the company is in discussion with the FDA to submit applications for emergency use authorization.

Source: Celltrion and the European Medicines Agency

EMA Begins Review of Novavax’s COVID-19 Vaccine 
The European Medicines Agency (EMA) has begun its review for conditional marketing authorization (CMA) for Novavax’s COVID-19 vaccine.

The EMA has indicated that its assessment will proceed under an accelerated timeline, with an opinion issued potentially within weeks (as reported on November 17, 2021). The chemistry, manufacturing and controls (CMC) data package submitted to the EMA and other global regulatory agencies uses Novavax’s manufacturing partnership with the Serum Institute of India (SII), a Pune, India-based vaccine manufacturer.

The Novavax/SII COVID-19 vaccine recently received emergency use authorization (EUA) in Indonesia and the Philippines, and the companies have also filed for EUA in India and for emergency use listing with the World Health Organization. Novavax also announced regulatory filings for its vaccine in the UK, Australia, New Zealand, and Canada.

Additionally, Novavax and SK bioscience, a vaccine developer and manufacturer based in South Korea, have submitted a biologics license application (BLA) for Novavax’s COVID-19 vaccine to South Korea’s Ministry of Food and Drug Safety. SK bioscience finalized an advance purchase agreement with the Korean government to supply 40 million doses of the vaccine to South Korea earlier this year (2021).

Novavax expects to submit the complete package to the US Food and Drug Administration (FDA) by the end of the year (2021).

Separately, Alcami, a CDMO of drug products and provider of analytical testing services, has signed a master laboratory services agreement with Novavax to provide analytical testing support for Novavax’s COVID-19 vaccine.

Source: Novavax (EU), Novavax (Philippines), Novavax (South Korea), and Alcami

AstraZeneca Reports New Analyses of COVID-19 Antibody Combo

AstraZeneca has reported that in outpatient treatment Phase III trials, AZD7442, its long-acting antibody (LAAB) combination, showed efficacy from a one-time intramuscular dose.

A six-months follow-up in a prevention trial showed that 83% reduced risk of symptomatic COVID-19, with no severe disease or deaths with AZD7442. Additionally, a separate treatment trial showed 88% reduced risk of severe COVID-19 or death when treated within three days of symptom onset.

Last month (October 2021), AstraZeneca submitted a request to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) for AZD7442 for prophylaxis of COVID-19. AstraZeneca has also agreed to supply the US government with 700,000 doses of AZD7442 if granted an EUA by the FDA and has agreements to supply to other countries.

Source: AstraZeneca

Daiichi Sankyo Starts Phase II Trial COVID-19 Vaccine in Japan
Daiichi Sankyo reports that the first patient has been dosed in a Phase II trial in Japan for DS-5670, its mRNA COVID-19 vaccine.

The company says it will also continue discussions with Japan’s Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency to determine the next steps for initiating development of a supplemental (booster) dose of DS-5670 by January 2022.

Source: Daiichi Sankyo

News on COVID-19 testing

FDA Updates COVID-19 Testing Policies
The US Food and Drug Administration (FDA) is taking several actions to support ongoing nationwide COVID-19 testing efforts to increase access of COVID-19 tests, particularly diagnostic tests, that can be performed at home or in doctor’s offices, hospitals, urgent-care centers, and emergency rooms, without having to be sent to a central lab for testing.

The US Department of Health and Human Services (HHS) withdrew a policy that directed the FDA not to enforce premarket review requirements for laboratory developed tests (LDTs). The FDA also updated its policies regarding tests, including LDTs, currently being offered prior to or without authorization, as well as policies regarding the types of tests on which the FDA intends to focus its review.

Moving forward, the FDA says it intends to focus its review on emergency use authorization requests for certain types of tests. Full details on these tests and key policy highlights can be found here.

Source: US Food and Drug Administration