COVID Roundup: Pfizer, J&J, Lilly, GSK & More

The latest on COVID-19 vaccines/drugs and manufacturing from Merck & Co., Gilead Sciences, Pfizer, AstraZeneca, Lilly, J&J, Roche, and Valneva.

Manufacturing and supply of COVID-19 vaccines and drugs

Merck & Co., Thermo Fisher in Mfg Pact for Oral COVID-19 Drug
Merck & Co. has entered into an agreement with Thermo Fisher Scientific to manufacture molnupiravir, Merck’s oral antiviral medicine for treating mild-to-moderate COVID-19 in adults.

Molnupiravir is being developed by Merck in collaboration with Ridgeback Biotherapeutics, a Miami, Florida-based bio/pharmaceutical company.

Thermo Fisher’s manufacturing site in Whitby, Ontario, will manufacture molnupiravir for distribution in Canada and the UK as well as markets in the European Union, Asia Pacific, and Latin America, pending local market approvals. It is one of three manufacturing sites globally for this therapy.

Earlier this month (December 2021), Merck announced that it had entered into a supply agreement with the Canadian government for molnupiravir. Through this agreement, the Canadian government has secured access to 500,000 patient courses, with options for up to 500,000 more in 2022.

Molnupiravir has been authorized for use in the UK. The US Food and Drug Administration is reviewing Merck & Co.’s application for emergency use authorization; an FDA advisory committee issued a positive opinion for the drug earlier this month (December 2021). The European Medicines Agency is reviewing Merck & Co.’s application for marketing authorization following a positive scientific opinion.

Source: Merck & Co.

Gilead Recalls Two Lots of COVID-19 Drug Remdesivir
Gilead Sciences is voluntarily recalling two lots of Veklury (remdesivir 100 mg for injection), its antiviral drug for treating COVID-19, to the user level due to a customer complaint, confirmed by the firm’s investigation, of the presence of glass particulates.

Veklury is indicated for the treatment of adults and pediatric patients ≥ 12 years old and weighing ≥40 kg requiring hospitalization for COVID-19. The lyophilized form of Veklury (remdesivir 100 mg for injection) is distributed in single dose clear glass vials in powder form and reconstituted at the site of use. The affected lots of Veklury were distributed nationwide in the US beginning in October 2021.

Source: Gilead Sciences

Valneva, Bahrain in Purchase Pact for COVID-19 Vaccine
Valneva, a Saint-Herblain, France-headquartered vaccine company, has signed a purchase agreement with the Kingdom of Bahrain for the supply of one million doses of the company’s inactivated COVID-19 vaccine candidate, VLA2001.

Valneva has initiated a rolling submission process with the Bahraini National Health Regulatory Authority (NHRA).

This is the second purchase agreement Valneva has secured for VLA2001 since reporting positive data for its Phase III clinical trial. Last month (November 2021), Valneva announced that the European Commission signed an advanced purchase agreement for up to 60 million doses of VLA2001.

Source: Valneva

Updates on COVID-19 treatments and vaccines

Pfizer, BioNTech Provide Vaccine Update on Omicron Variant
Pfizer and BioNTech report results from an initial laboratory study demonstrating that serum antibodies induced by their COVID-19 vaccine neutralize the SARS-CoV-2 Omicron variant after three doses.

Sera obtained from vaccinees one month after receiving the booster vaccination (third dose of the COVID-19 vaccine) neutralized the Omicron variant to levels that are comparable to those observed for the wild-type SARS-CoV-2 spike protein after two doses.

The companies say they will continue to collect more laboratory data and evaluate real-world effectiveness to assess and confirm protection against Omicron. Last month (November 2021), the companies started to develop an Omicron-specific COVID-19 vaccine. The development will continue as planned in the event that a vaccine adaption is needed to increase the level and duration of protection against Omicron. First batches of the Omicron-based vaccine can be produced and are planned to be ready for deliveries within 100 days, pending regulatory approval.

Source: Pfizer and BioNTech

FDA Authorizes AstraZeneca’s COVID-19 Antibody Combo
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), formerly AZD7442, its long-acting antibody (LAAB) combination, for the prevention of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).

AstraZeneca says it expects first doses to become available very soon (as reported on December 8, 2021). AstraZeneca has agreed to supply the US government with 700,000 doses of Evusheld. The US government has indicated that it plans to distribute these doses to states and territories at no cost and on a pro rata basis.

AstraZeneca is progressing with filings globally for potential emergency use authorization or conditional approval of Evusheld in both COVID-19 prophylaxis and treatment.

Source: AstraZeneca and the US Food and Drug Administration

FDA Expands EUA of Lilly’s COVID-19 Combo Therapy
The US Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) for Eli Lilly and Company’s COVID-19 treatment of bamlanivimab and etesevimab, administered together, to include certain high-risk pediatric patients from birth to <12 years old. The product was developed by Lilly and AbCellera, a Vancouver, British Columbia, Canada-based bio/pharmaceutical company.

This revision also authorizes bamlanivimab and etesevimab, to be administered together, for post-exposure prophylaxis for prevention of COVID-19 in all pediatric patients, including newborns, at high risk of progression to severe COVID-19, including hospitalization or death.

In February (February 2021), the FDA originally authorized bamlanivimab and etesevimab administered together to treat mild-to moderate COVID-19 in adults and pediatric patients (12 years of age or older). In September (September 2021), the agency authorized its use for post-exposure prevention of COVID-19 in certain adults and pediatric individuals (12 years of age and older).

Bamlanivimab and etesevimab, when administered together, retain neutralization activity against the Delta variant. Lilly says it is working to understand neutralization activity of our therapies on the Omicron variant of concern.

Source: US Food and Drug Administration and Eli Lilly and Company

EU OKs Roche’s Arthritis Drug for Treating COVID-19
The European Commission (EC) has extended the marketing authorization for Roche’s Actemra/RoActemra (tocilizumab), a drug for treating rheumatoid arthritis, to include the treatment of COVID-19 in adults.

This decision from the EC comes follows an accelerated assessment by the European Medicines Agency’s Committee for Medicinal Products for Human Use, which reviewed results from four studies of Actemra/RoActemra in over 5,500 patients with severe or critical COVID-19.

Outside of the European Union, Actemra/RoActemra has been provisionally approved in Australia, authorized for emergency use in the US and Ghana, and recommended by the World Health Organization for the treatment of COVID-19. Roche says it is working closely with regulatory bodies and other partners globally.

Source: Roche

UK Grants Conditional OK for GSK’s/Vir’s COVID-19 Drug
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorization for Xevudy (sotrovimab), an investigational monoclonal antibody for treating adults and adolescents with COVID-19, by GlaxoSmithKline’s (GSK) and Vir Biotechnology’s, a San Francisco-based bio/pharmaceutical company.

The conditional marketing authorization is based on Phase III data showing sotrovimab reduced the risk of hospitalization or death by 79% in adult patients with an increased risk of progressing to severe COVID-19.

In the coming weeks (as reported on December 2, 2021), UK patients at increased risk of severe complications of COVID-19 will be able to access sotrovimab following a supply agreement with the UK government. The conditional marketing authorization covers England, Scotland, and Wales. Supply of sotrovimab in Northern Ireland is enabled under the regulation 174 of the Human Medicines Regulations 2012.

Separately, GSK and Vir have reported preclinical data demonstrating that sotrovimab retains in vitro activity against the Omicron spike protein (B.1.1.529).

Source: GlaxoSmithKline (UK conditional approval) and GlaxoSmithKline (preclinical results)

J&J Reports Phase II Data for COVID-19 Vaccine Booster
Johnson & Johnson (J&J) has announced preliminary results from a Phase II study and a sub-study which showed that a booster shot of the J&J COVID-19 vaccine, administered at six months after a two-dose primary regimen of Pfizer’s/BioNTech’s COVID-19 vaccine (BNT162b2) increased both antibody and T-cell responses. The company says these results demonstrate the potential benefits of heterologous boosting (mix-and-match). 

In collaboration with academic groups in South Africa and globally, J&J also has been evaluating the effectiveness of its COVID-19 vaccine across variants, now including the new Omicron variant. In addition, J&J says it is pursuing an Omicron-specific variant vaccine and will progress it as needed.

Source: Johnson & Johnson

GSK, Medicago Report Phase III Results for COVID-19 Vaccine
GlaxoSmithKline (GSK) and Medicago, a Quebec-based biopharmaceutical company, have reported positive Phase III data for Medicago’s plant-based COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant, conducted in over 24,000 subjects (adults 18 years and above) across six countries.

Based on these results, Medicago will imminently seek regulatory approval from Health Canada, the regulatory body of Canada, as part of its rolling submission. The vaccine candidate is not yet approved by any regulatory authority.

Medicago has also initiated the regulatory filing process for the adjuvanted plant-based COVID-19 vaccine candidate with the US Food and Drug Administration and the UK’s Medicines and Healthcare products Regulatory Agency. Preliminary discussion is underway with the World Health Organization for preparation of the submission. Medicago has also initiated a Phase I/II trial in Japan, where it plans to submit for regulatory approval in combination with the Phase II/III global study results next spring (spring 2022).

Source: GlaxoSmithKline