COVID-19 News: Pfizer, Lilly, J&J, Moderna & MoreBy
The latest on COVID-19 vaccines/drugs and manufacturing from Pfizer, Lilly, J&J, Moderna, Emergent BioSolutions, Regeneron Pharmaceuticals, Valneva, and Inovio.
Manufacturing and supply of COVID-19 vaccines and drugs
US Gov’t, Emergent End COVID-19 Vaccine Mfg Pact
Emergent BioSolutions, a Gaithersburg, Maryland-based specialty bio/pharmaceutical company and contract manufacturer, and the US government have mutually terminated their manufacturing contract for COVID-19 vaccines.
In 2020, the company was issued a task order under its existing Center for Innovation in Advanced Development and Manufacturing (CIADM) agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services. The initial task order had a contract value of up to $628.2 million and included the reservation of manufacturing capacity and accelerated expansion of fill–finish capacity valued at $542.7 million and $85.5 million, respectively. Subsequently, the task order was expanded to include incremental capital activities that increased the value to $650.8 million.
On November 1, 2021, the company and BARDA mutually agreed to terminate the company’s CIADM contract and associated task orders, including the BARDA COVID-19 public–private partnership. The terms of the contract modification reduced the contract value of the BARDA COVID-19 contract to $470.9 million from $650.8 million and the base CIADM contract value was reduced to $140.5 million from $163.2 million. As a result of the termination, the company expects to record approximately $215.9 million of revenue in the fourth quarter of 2021, which includes $155.7 million of lease revenue upon receipt of cash payments and $60.2 million of contract and grant revenue from the original CIADM arrangement, of which $55.2 million is recorded as deferred revenue. In addition, the company expects to recognize a research and development expense of $38.2 million due to the removal of a contract asset associated with the CIADM arrangement.
J&J, US Gov’t, Gavi in Supply Pact for COVID-19 Vaccine
Johnson & Johnson (J&J) has entered into an agreement with the US government and Gavi, a global vaccine alliance, to enable access to its COVID-19 vaccine to people in conflict zones through the COVAX Humanitarian Buffer, which is part of the COVAX Facility, a global initiative for equitable for COVID-19 vaccines and treatments.
The first deliveries to the COVAX Humanitarian Buffer are anticipated to begin in the coming days (as reported on November 10, 2021). Governments and national and international humanitarian agencies are eligible to apply to receive the doses.
J&J says it is committed to facilitating equitable global access to its COVID-19 vaccine. The company has committed to providing its vaccine on a not-for-profit basis globally for emergency pandemic use and is making available up to 900 million doses of its vaccine to the COVAX Facility and the African Union through 2022.
Source: Johnson & Johnson
Valneva, EU in Supply Pact for COVID-19 Vaccine
Valneva, a Saint-Herblain, France-based vaccines company, reports that the European Commission (EC) has approved an agreement under which Valneva would supply up to 60 million doses of VLA2001, its COVID-19 vaccine candidate, over two years, including approximately 27 million doses in 2022.
Under the agreement, the EC has the option to increase its initial purchase, in 2022, of VLA2001 up to a total of 60 million doses by the end of 2023. The agreement will be completed following final review, including volumes required, by each of the European Union member states. The announcement follows the conclusion of advanced exploratory talks with the EC that began in January 2021. Delivery of the vaccine is currently expected to begin in April 2022, subject to approval by the European Medicines Agency, which is expected to start a rolling review of VLA2001 shortly (as reported on November 10, 2021).
Updates on COVID-19 treatments and vaccines
Lilly Withdraws COVID-19 Treatments from EMA Review
The European Medicines Agency (EMA) has ended the rolling review of bamlanivimab and etesevimab, two monoclonal antibodies from Eli Lilly and Company, co-administered for treating COVID-19 after the company informed the agency that it was withdrawing from the process.
Since March 2021, EMA’s Committee for Medicinal Products for Human Use (CHMP) has been reviewing data on these medicines as part of a rolling review. In March 2021, the EMA also issued advice for treating COVID-19 based on data from a clinical study. This advice supported the use of the antibodies at national levels before a marketing authorization.
The EMA had received non-clinical (laboratory) data, data from clinical studies, data on the quality and manufacturing process of the antibodies, and a risk management plan as part of the data submitted in the rolling review. With respect to manufacturing, the EMA’s CHMP had determined that prospective concurrent validation was required for submission of a formal marketing authorization application.
“Given the current demand from EU member states, Lilly forecasts that no additional or new drug-substance manufacturing campaigns will be needed for the foreseeable future,” said the company in its October 29, 2021 letter of withdrawal to the EMA. “Therefore, at this point, Lilly is not in a position to generate the additional data required by the CHMP to progress to a formal marketing authorization application.”
The company retains the right to request another rolling review or submit a marketing authorization application in the future.
Source: European Medicines Agency
Moderna Seeks EU OK for COVID-19 Vaccine in Children
Moderna has filed with the European Medicines Agency (EMA) to expand its conditional marketing authorization for its COVID-19 vaccine, Spikevax, in the European Union (EU) to include a 50-µg two-dose series in children ages 6–11 years.
The EMA has started evaluating the application to extend the use of Spikevax to children aged 6 to 11. Spikevax was first authorized in the EU in January 2021.
Earlier this year (July 2021) the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine to include adolescents 12 years of age and older.
Pfizer Reports Interim Results for Oral COVID-19 Drug
Pfizer reports that its investigational COVID-19 oral antiviral candidate, Paxlovid, reduced hospitalization and death by 89% in non-hospitalized high-risk adults with COVID-19 based on an interim analysis of a Phase II/III study.
At the recommendation of an independent data monitoring committee and in consultation with the US Food and Drug Administration (FDA), Pfizer will cease further enrollment into the study due to the efficacy demonstrated in these results. The company says it plans to submit the data as part of its ongoing rolling submission to the FDA for emergency use authorization as soon as possible (as reported on November 5, 2021).
Regeneron Reports Results for COVID-19 Antibody Cocktail
Regeneron Pharmaceuticals reports additional positive results from a Phase III trial, which assessed a single dose of REGEN-COV (casirivimab and imdevimab) to prevent COVID-19 in uninfected individuals. The dosing level was 1,200 mg administered via four subcutaneous injections.
The company reported REGEN-COV reduced the risk of contracting COVID-19 by 81.6% during the pre-specified follow-up period (months two through eight) and maintained the 81.4% risk reduction previously reported during the first month after administration.
REGEN-COV is currently authorized in the US to treat people who are at high risk of serious consequences from COVID-19 infection who are either already infected (non-hospitalized) or in certain post-exposure prophylaxis settings.
FDA OKs Phase III Trial of Inovio’s COVID-19 Vaccine
Inovio, a Plymouth Meeting, Pennsylvania-based bio/pharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases, has received authorization from the US Food and Drug Administration (FDA) to proceed with the Phase III segment of its planned Phase II/III clinical trial for INO-4800, its COVID-19 vaccine candidate.
The FDA has lifted the partial clinical hold following the FDA’s review of additional non-clinical, clinical, and device information provided by Inovio.
Inovio is partnering with Advaccine Biopharmaceuticals Suzhou, a Suzhou, China-based bio/pharmaceutical company, to conduct the Phase III segment in multiple countries in the Americas, Asia, and Africa.