Pharma COVID Roundup: News from Pfizer, Moderna, and AstraZeneca
The latest on COVID-19 vaccines/drugs and manufacturing from Pfizer, Moderna, AstraZeneca, J&J, Emergent BioSolutions, Sanofi, GSK, Vir Biotechnology, BI, Sinovac, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
Pfizer, BioNTech in US Gov’t Pact for More Doses of COVID-19 Vaccine
The US government has purchased an additional 200 million doses of Pfizer’s/BioNTech’s COVID-19 vaccine.
These doses are expected to be delivered from October 2021 through April 2022. This brings the total number of doses to be supplied by the companies to the US government under its existing supply agreement to 500 million.
The companies expect to deliver 110 million of the additional doses by December 31, 2021, with the remaining 90 million doses to be delivered no later than April 30, 2022. The US government also has the option to acquire an updated version of the vaccine to address potential variants as well as new formulations of the vaccine, if available and authorized.
Separately, last month (June 2021), Pfizer and BioNTech shared plans to provide the US government with 500 million doses of their COVID-19 vaccine for donation to low- and lower middle-income countries.
Moderna To Supply Taiwan with More Doses of COVID-19 Vaccine
Moderna, a bio/pharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has entered into a new supply agreement with Taiwan for up to 35 million doses of its COVID-19 vaccine and its updated variant booster vaccine candidate.
If authorized, the company will supply 20 million doses of its COVID-19 vaccine and its updated variant booster vaccine candidate to begin delivery in 2022 and an additional 15 million doses in 2023. This new supply agreement is in addition to the prior agreement for 5 million doses in 2021.
Emergent BioSolutions To Resume COVID-19 Vaccine Mfg
The US Food and Drug Administration (FDA) is allowing Emergent BioSolutions, a Gaithersburg, Maryland-based specialty biopharmaceutical company and contract manufacturer, to resume production of Johnson & Johnson’s (J&J) COVID-19 vaccine bulk drug substance at its Bayview manufacturing facility in Baltimore, Maryland.
Since production was paused at the Bayview facility earlier this year (April 2021), Emergent has worked with the FDA and J&J to address quality concerns, including developing and executing an action plan and committing resources to bring operations up to FDA standards. Emergent expects to continue to work with the FDA throughout the manufacturing process.
Source: Emergent BioSolutions
Aspen Pharmacare in Supply Pact for J&J’s COVID-19 Vaccine
Aspen Pharmacare, a Durban, South Africa-based pharmaceutical company, will supply South Africa with Johnson & Johnson’s (J&J) COVID-19 vaccine from Aspen’s production site in Gqeberha, South Africa.
These vaccines will be distributed throughout South Africa in line with the various distribution arrangements between J&J, the National Department of Health, and other stakeholders. In addition, vaccines from these batches will be made available through the African Vaccine Acquisition Task Team/African Union platform.
Supplies will also be made to the European Union and other offshore markets.
Source: Aspen Pharmacare
GSK, Vir in Pact with EU for COVID-19 Drug
GlaxoSmithKline (GSK) and Vir Biotechnology, a San Francisco-based clinical-stage bio/pharmaceutical company, have signed a joint procurement agreement with the European Commission to supply up to 220,000 doses of sotrovimab, an investigational monoclonal antibody for treating adults and adolescents with COVID-19.
The joint procurement agreement enables participating European Union (EU) member states to purchase sotrovimab, following local emergency authorization or authorization at the EU level, to treat high-risk patients with COVID-19 who may benefit from early treatment with sotrovimab.
This action follows the positive scientific opinion issued by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
GSK and Vir have secured supply agreements with multiple governments globally. In May 2021, sotrovimab was granted emergency use authorization by the US Food and Drug Administration (FDA) for the treatment of mild-to-moderate COVID-19 in high-risk patients. GSK and Vir have announced plans to submit a biologics license application to the FDA in the second half of 2021. Sotrovimab has also been authorized for emergency use in Bahrain, Kuwait, Qatar, Singapore and United Arab Emirates.
Updates on COVID-19 treatments and vaccines
EMA Authorizes Moderna’s COVID-19 Vaccine for Adolescents
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine, Spikevax, to include adolescents 12 years of age and older. Spikevax is the trade name authorized by the EMA for Moderna’s COVID-19 vaccine.
Following the CHMP’s positive opinion, the European Commission will evaluate the use of Moderna’s COVID-19 vaccine in adolescents ages 12 years of age and older.
Last month (June 2021), Moderna filed for authorization for its COVID-19 vaccine in adolescents aged 12 to 18 with the EMA as well as the US Food and Drug Administration and Health Canada, the pharmaceutical regulatory body of Canada. Moderna is also conducting a Phase II/III study of its COVID-19 vaccine in children ages six months to less than 12 years.
FDA Extends Shelf Life for J&J’s COVID-19 Vaccine
The US Food & Drug Administration (FDA) has extended the shelf life for Johnson & Johnson’s (J&J) COVID-19 vaccine to six months.
The decision is based on data from ongoing stability assessment studies, which have demonstrated the vaccine is stable at six months when refrigerated at temperatures of 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius).
Source: Johnson & Johnson
EMA Lists Very Rare Side Effect for J&J’s COVID-19 Vaccine
The European Medicines Agency (EMA) has listed Guillain-Barré syndrome (GBS) as a very rare side effect of Johnson & Johnson’s (J&J) COVID-19 vaccine and a warning will be included in the product information for healthcare professionals and recipients of the vaccine.
GBS is a rare neurological disorder in which the body’s immune system damages nerve cells that can result in pain, numbness and muscle weakness, progressing to paralysis in the most severe cases.
The EMA confirms that the benefits of J&J’s COVID-19 vaccine continue to outweigh the risks of the vaccine.
Source: European Medicines Agency
EMA Starts Rolling Review of Sanofi’s COVID-19 vaccine
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur, Sanofi’s vaccines global business unit.
The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies and early clinical studies in adults, which suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease.
The EMA will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for a formal marketing authorization application.
Source: European Medicines Agency
EMA Starts Evaluating Sobi’s Arthritis Drug to Treat COVID-19
The European Medicines Agency (EMA) has started evaluating an application to extend the use of Sobi’s Kineret (anakinra), an arthritis drug, to include treatment of COVID-19 in adult patients with pneumonia who are at risk of developing severe respiratory failure.
Kineret is an immunosuppressant currently authorized for the treatment of a number of inflammatory conditions. Its active substance, anakinra, blocks the activity of interleukin 1, a chemical messenger involved in immune processes that lead to inflammation.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) will assess data submitted in the application to decide whether to recommend the extension of indication. Data submitted include results from two ongoing clinical studies evaluating the medicine in adult patients hospitalized with COVID-19. Kineret has been authorized in the EU since March 2002.
Source: European Medicines Agency
AstraZeneca Reports Results for COVID-19 Vaccine Against Variants
AstraZeneca reports that real-world data from Canada of its COVID-19 vaccine, Vaxzevria, was 82% and 87% effective after one dose against hospitalization or death caused respectively by Beta/Gamma and Delta variants of SARS-CoV-2, the virus that causes COVID-19.
The effectiveness of Vaxzevria after one dose against hospitalization or death was similar to that of other vaccines tested in the study from the Canadian Immunization Research Network with support from the Public Health Agency of Canada and the Canadian Institutes of Health Research. Follow-up time was not sufficient to report on effectiveness of Vaxzevria after two doses; other studies have shown an increased effectiveness following the indicated two-dose schedule.
The analysis included 69,533 individuals who tested positive for SARS-CoV-2 during December 2020 to May 2021 in Ontario, Canada, with 28,705 (6.8%) positive for non-variants of concern SARS-CoV-2 and 40,828 (9.7%) positive for a variant of concern.
Separately, the company reports that Vaxzevria and mRNA COVID-19 vaccines showed similar and favorable safety profiles in a large real-world study of over one million individuals with incidence rates of blood-clotting disorders of thromboembolism and thrombocytopenia, including the very rare thrombosis with thrombocytopenia (TTS) following vaccination. The company also reported that rates of the very rare clotting disorder, thrombosis with TTS, following a second dose of Vaxzevria are comparable to the background rate in an unvaccinated population.
Boehringer Ingelheim Shifts Focus of COVID-19 Clinical Research
Boehringer Ingelheim (BI) has decided to focus its COVID-19 therapy research on the development of alteplase, a blood-clot-dissolving treatment for acute ischemic stroke therapy, as a potential treatment for COVID-19 patients with severe breathing problems, or acute respiratory distress syndrome (ARDS).
The decision is based on favorable safety and efficacy data from an interim analysis of a Phase II/III study, following completion of the Phase IIb part of the study. BI is working toward starting the Phase III part of the study in the fourth quarter of this year to confirm and further investigate the effects of alteplase in patients with COVID-19 ARDS and prepare for potential submission for approval.
Source: Boehringer Ingelheim
Sinovac Reports Positive Results for COVID-19 Vaccine Booster
Sinovac Biotech, a Beijing, China-based bio/pharmaceutical company, reported positive results for the booster dose of its COVID-19 vaccine, CoronaVac, among adults aged 18 through 59 years of age.
The company reported that results indicate that a two-dose schedule generates good immune memory. After a third dose was given six to eight months after the second dose, strong immune response was induced quickly and the neutralizing antibody titers at Day 28 after the third dose increased by three to five times higher than the level recorded on Day 28 after the second shot. In addition, the findings brought on evidence showing that longer intervals between the third dose and the second dose result in higher antibody levels.
Meissa Reports Positive Preclinical Data for Intranasal COVID-19 Vaccine
Meissa Vaccines, a Redwood City, California-based bio/pharmaceutical company developing vaccines to prevent viral respiratory infections, reports positive preclinical data in nonhuman primates for its intranasal recombinant live attenuated COVID-19 vaccine, MV-014-212.
The company reported that MV-014-212 induced mucosal as well as systemic antibodies against SARS-CoV-2, the virus that causes COVID-19, and two variants of concern. MV-014-212 was built on the company’s AttenuBlock platform and is designed to be appropriately attenuated, genetically stable, and optimized to drive immunity. Interim analysis of the trial data is expected later this year (2021).
Source: Meissa Vaccines