Pharma COVID Roundup: News from J&J, Lilly, Moderna, Pfizer, Regeneron
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The latest on COVID-19 vaccines/drugs and manufacturing from J&J, Lilly, Regeneron, Moderna, Pfizer/BioNTech, CureVac, Valneva, Sinovac, and the FDA.

Manufacturing and supply of COVID-19 vaccines and drugs

FDA OKs Additional Batch of J&J’s COVID-19 Vaccine
The US Food and Drug Administration (FDA) has approved the use of an additional batch of Johnson & Johnson’s (J&J) COVID-19 vaccine substance manufactured at Emergent BioSolutions’ facility in Baltimore, Maryland.

To date (as reported on September 10, 2021), a total of six batches of J&J vaccine substance that were manufactured at the Emergent facility have been authorized. The FDA had previously approved two batches In July (July 2021) and three batches in June (June 2021). The FDA’s review of the batches and subsequent approval of select batches followed earlier quality issues at the facility. The FDA said it conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review, the FDA concluded that these batches are suitable for use.

While the FDA says it is not yet ready to include the Emergent plant in the EUA as an authorized manufacturing facility, the agency says it continues to work through issues there with J&J and the management of Emergent BioSolutions.

Source: US Food and Drug Administration


Lilly To Supply US Gov’t with mAb in COVID-19 Antibody Combo
The US government has agreed to purchase 388,000 doses of etesevimab, a monoclonal antibody (mAb) that is part of Eli Lilly and Company’s antibody combination of etesevimab and bamlanivimab for treating COVID-19.

Lilly will supply 388,000 doses of etesevimab to complement doses of bamlanivimab previously purchased by the US government, with approximately 200,000 doses expected to ship in the third quarter of 2021 and the remaining to be shipped in the fourth quarter of 2021

Earlier this month (September 2021) the Office of the Assistant Secretary for Preparedness and Response (ASPR), alongside the US Food and Drug Administration (FDA), resumed the shipment and distribution of bamlanivimab and etesevimab administered together.

For Lilly, the transaction is expected to generate approximately $330 million in revenue in the second half of 2021.

Source: Eli Lilly and Company


US Gov’t To Buy More Doses of Regeneron’s COVID-19 Antibody Cocktail
The US government has agreed to purchase 1.4 million additional doses of REGEN-COV (casirivimab and imdevimab), the antibody cocktail for treating COVID-19 from Regeneron Pharmaceuticals, a Tarrytown, New York-based bio/pharmaceutical company.

Under the new agreement, Regeneron will supply an additional 1.4 million does (1,200-mg dose) of REGEN-COV to the US government by January 31, 2022, at a cost of $2,100 per dose. This new agreement follows two earlier agreements with the US government announced in July 2020 and January 2021.

Regeneron invented REGEN-COV and is collaborating with Roche to increase global supply, with Roche primarily responsible for development and distribution outside the US.

Regeneron expects to begin delivering the additional REGEN-COV doses to the US government in September (September 2021), with the majority delivered in the fourth quarter of 2021. Pursuant to a prior agreement, Roche will manufacture approximately one third of the doses for Regeneron to fulfill this new agreement with the US government.

Source: Regeneron Pharmaceuticals


CureVac Adjusts European Mfg Network for COVID-19 Vaccine
CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics and vaccines, is adjusting its external European manufacturing network for its mRNA-product pipeline, including for its COVID-19 vaccine.

The company says it made the decision as a result of changes in expected demand for its COVID-19 vaccine candidate, CVnCoV, currently under regulatory review with the European Medicines Agency.

As a result, its existing contracts with Wacker, a Munich, Germany-based chemical and biomanufacturing company, for the manufacturing of the mRNA vaccine substance of CVnCoV and with Celonic, a Basel, Switzerland-based CDMO, for the manufacturing and formulation of the mRNA vaccine substance of CVnCoV will be terminated.

CureVac’s existing agreements with Rentschler Biopharma, a Laupheim, Germany-based CDMO, and Novartis for mRNA production and formulation are unaffected by this adjustment and remain in place.

CureVac says that the streamlining of capacity does not limit availability of clinical trial material for CV2CoV, a second-generation version of its COVID-19 vaccine, which is expected to enter the clinic in the fourth quarter of 2021. That vaccine candidate is being jointly developed with GlaxoSmithKline.

Source: CureVac


UK Gov’t Terminates Supply Pact for Valenva’s COVID-19 Vaccine
Valneva, a Saint-Herblain, France-headquartered vaccine company, has received a termination notice from the UK government for its supply agreement of its COVID-19 vaccine candidate, VLA2001.

According to a September 13, 2021 statement from Valneva, “the UK government has alleged that Valneva is in breach of its obligations under the supply agreement, but the company strenuously denies this.”

Valneva is continuing its VLA2001 development plan. Testing for the company’s Phase III trial is ongoing at Public Health England. Valneva recently announced that its Phase III results are expected to be available early in the fourth quarter of 2021 and that these results will form part of its rolling submission for conditional approval of VLA2001 with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Subject to these data and MHRA approval, Valneva says it believes that initial approval for VLA2001 could be granted in late 2021.

Source: Valneva


Sinovac To Supply More Doses of COVID-19 Vaccine to Singapore
Sinovac Biotech, a Beijing, China-based bio/pharmaceutical company, has agreed to supply Singapore with an additional 101,000 doses of its COVID-19 vaccine, CoronaVac.

The additional doses are expected to arrive in Singapore on September 20, 2021. The doses will be available through the healthcare group, Livingstone Health Holding Limited. Singapore’s Ministry of Health had earlier procured 200,000 doses of CoronaVac, 170,000 of which were made available to the public at primary care clinics.

Source: Sinovac


Updates on COVID-19 treatments and vaccines

FDA To Meet Sept. 17th To Review Booster Dose of Pfizer’s/BioNTech’s COVID Vaccine
The US Food and Drug Administration has posted briefing documents in advance of the September 17, 2021 meeting of the FDA’s Vaccines and Related Products Advisory Committee to evaluate the supplemental biologics license application for a third (booster) dose of Pfizer’s/BioNTech’s COVID-19 vaccine in individuals 16 years of age and older.

The materials and instructions on how to view the public meeting may be found here.

Source: US Food and Drug Administration


Moderna Reports Data for COVID-19 Vaccine Against Variants
Moderna, a bio/pharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, reports new analyses suggesting that its COVID-19 vaccine, mRNA-1273, is highly effective against circulating variants of concern.

The first new analysis was part of a real-world effectiveness study conducted in partnership with Kaiser Permanente Southern California, a healthcare center part of a managed care consortium, and in a separate recent publication by the US Centers for Disease Control and Prevention.

Additionally, Moderna shared a new analysis of the incidence of breakthrough COVID-19 cases among vaccinated participants from a Phase III study conducted between July 1, 2021 and August 27, 2021. The analysis shows lower risk of breakthrough infection in participants vaccinated more recently (median eight months after first dose) than participants vaccinated last year (median 13 months after first dose). The company believes this adds to evidence of potential benefit of a booster dose of mRNA-1273.

Full details of each analysis can be found here.

Source: Moderna


Sinovac Reports Data on COVID-19 Vaccine Against Variants
Sinovac Biotech, a Beijing, China-based bio/pharmaceutical company, has reported that a third dose of its COVID-19 vaccine, CoronaVac, shows positive results against COVID-19 and variants of concern, including the Delta variant.

Source: Sinovac


FDA Revises Guidance on Generic Drug Applications During COVID-19 Pandemic
The US Food and Drug Administration (FDA) has revised its guidance, Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers,, originally published in April 2021. The guidance provides general recommendations to prospective generic drug applicants related to generic drug product development and regulatory submissions in the form of questions and answers that have been received and addressed by the FDA during the COVID-19 public health emergency.

Source: US Food and Drug Administration


FDA Issues Statement on COVID-19 Vaccines for Children
The US Food and Drug Administration (FDA) has issued a statement on ensuring the safety and efficacy of COVID-19 vaccines and products for children younger than 12 years of age.

The statement titled “FDA Will Follow The Science On COVID-19 Vaccines For Young Children” is attributed to Acting FDA Commissioner Janet Woodcock M.D. and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Research and Evaluation. In the statement, the FDA notes the steps that the agency will take to ensure the efficacy of these COVID-19 products for children, including conducting clinical trials to determine an appropriate vaccine dose in children.

In its September 12, 2021 statement, the agency stressed it will assess data in making any determination about COVID-19 vaccines in young children. “We may also consult with our Vaccines and Related Biological Products Advisory Committee on any questions that warrant a public discussion by external experts,” Dr. Woodcock and Dr. Marks said in the statement, “[O]nce a decision to authorize or approve a vaccine for a younger population has been made, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to discuss further clinical recommendations.”

Source: US Food and Drug Administration