Pharma COVID Roundup: News from Moderna and J&JBy
The latest on COVID-19 vaccines/drugs and manufacturing from Moderna and J&J.
Manufacturing and supply of COVID-19 vaccines and drugs
Recipharm Site Approved for Mfg of Moderna’s COVID-19 Vaccine
Recipharm, a CDMO of active pharmaceutical ingredients (APIs) and drug products, has been approved for and has started manufacturing the drug product of Moderna’s COVID-19 vaccine at its site in in Monts, France following approval from the European Medicines Agency’s Committee for Human Medicines.
Moderna says its partnership with Recipharm is reflective of the company’s commitment to expanding its global manufacturing capacity. Investments made earlier this year (2021) are expected to enable a doubling of drug-substance manufacturing in Europe. When completed, the investments are expected to also result in an increase in safety stock of raw materials and finished product used to deliver committed volumes.
FDA Authorizes Additional Batch of J&J’s COVID-19 Vaccine
The US Food and Drug Administration (FDA) has authorized, under emergency use authorization (EUA), 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 July 2, 2021), a total of four batches of J&J drug substance that were manufactured at the Emergent facility have been authorized. Last month (June 2021), the FDA approved three batches of the drug substance. 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 Emergent BioSolutions management.
Source: US Food and Drug Administration
Updates on COVID-19 treatments and vaccines
J&J Reports Data for COVID-19 Vaccine Against Delta Variant
Johnson & Johnson (J&J) reports data that demonstrated that its COVID-19 vaccine generated strong activity against the COVID-19 Delta variant and other SARS-CoV-2 viral variants.
Data from a Phase III trial showed that the company’s vaccine generated neutralizing antibody activity against the Delta variant at a higher level than what was recently observed for the Beta (B.1.351) variant in South Africa, where high efficacy against severe/critical disease was demonstrated.
The company reported that the vaccine was 85% effective against severe/critical disease and demonstrated protection against hospitalization and death. The company said that the vaccine was consistently effective across all regions studied globally, including in South Africa and Brazil, where there was a high prevalence of rapidly emerging Beta and Zeta (P.2) variants during the study period.
Additionally, the data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date (as reported on July 1, 2021).
Source: Johnson & Johnson