Pharma COVID Roundup: News from Pfizer, J&J, and Sinovac
The latest on COVID-19 vaccines/drugs from Pfizer, J&J, Sinovac, Biological E., Providence Therapeutics, and the National Institutes of Health.
Manufacturing and supply of COVID-19 vaccines and drugs
EMA OKs More Mfg Capacity for Pfizer’s, BioNTech’s COVID-19 Vaccine
The European Medicines Agency (EMA) has recommended the approval of additional manufacturing and filling lines for Pfizer’s/BioNTech’s COVID-19 vaccine at Pfizer’s vaccine manufacturing site in Puurs, Belgium
The recommendation by the EMA’s Committee for Human Medicines (CHMP) enables Pfizer/BioNTech to increase the volumes of vaccines produced at this site.
Separately, Pfizer and BioNTech have announced that the conditional marketing authorization (CMA) in the European Union (EU) for Comirnaty, the name of their COVID-19 vaccine, has been expanded to include individuals 12 to 15 years of age. The extended indication for the CMA for Comirnaty is valid in all 27 EU member states. Last month (May 2021), the US Food and Drug Administration had authorized the vaccine for this age group.
A pediatric study evaluating the safety and efficacy of the COVID-19 vaccine in children six months to 11 years of age is ongoing. Pfizer and BioNTech expect to have definitive readouts and, subject to the data generated, submit for an emergency use authorization (in the US) or a variation to conditional marketing authorizations (in the EU) for two cohorts, including children two to five years of age and five to 11 years of age, in September (September 2021). The readout and submission for the cohort of children six months to two years of age are expected in the fourth quarter of 2021.
Providence Therapeutics, Biological E in Pact for COVID-19 Vaccine
Biological E. Limited (Biological E), a Hyderabad, India based vaccine and pharmaceutical company, has entered into a licensing and collaboration agreement with Providence Therapeutics, a Canadian clinical-stage bio/pharmaceutical company, to purchase up to 30 million doses of Providence’s mRNA COVID-19 vaccine, PTX-COVID19-B.
This sale represents the sale of all the remaining 2021 Providence production, plus a portion of the early 2022 Providence production, after accounting for the first sale of Providence vaccines to the Province of Manitoba, Canada.
Providence will provide the necessary technology transfer for Biological E to manufacture mRNA vaccines in India, with a minimum production capacity of 600 million doses in 2022 and a target capacity of one billion doses. Biological E will be responsible for all clinical development and regulatory activities for the mRNA vaccine in India and other jurisdictions licensed by Biological E.
Updates on COVID-19 treatments and vaccines
UK Approves J&J’s COVID-19 Vaccine
Johnson & Johnson’s (J&J) COVID-19 vaccine has been given regulatory approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA) after meeting the required safety, quality and effectiveness standards.
The MHRA obtained independent scientific advice from the Commission on Human Medicines and its COVID-19 Expert Working Group. This is the fourth COVID-19 vaccine to be authorized in the UK and is the first to be approved for protection against COVID-19 with a single dose.
NIH Begins Trials of Mixed COVID-19 Vaccines
The National Institutes of Health (NIH) has started a Phase I/II clinical trial in which adult volunteers who have been fully vaccinated against COVID-19 will receive booster doses of different COVID-19 vaccines to determine the safety and immunogenicity of mixed boosted regimens.
The National Institute of Allergy and Infectious Diseases, part of NIH, is leading and funding the study through the Infectious Diseases Clinical Research Consortium, a clinical trials network that encompasses the Institute’s Vaccine and Treatment Evaluation Units. Initial trial results are expected in late summer 2021.
The trial will include approximately 150 individuals who already have received one of the three COVID-19 vaccine regimens currently available under US Food and Drug Administration emergency use authorization in the US, by Johnson & Johnson’s, Moderna’s and Pfizer’s/BioNTech’ COVID-19 vaccines.
Source: National Institutes of Health
WHO Validates Sinovac’s COVID-19 Vaccine
Sinovac Biotech, a Beijing, China-based bio/pharmaceutical company, reports that The World Health Organization (WHO) has validated for emergency use the COVID-19 vaccine of Sinovac Life Sciences, a subsidiary of Sinovac Biotech.
WHO’s emergency use listing (EUL) procedure is a prerequisite for the COVAX Facility, a global initiative for equitable access to COVID-19 vaccines, vaccine supply, and international procurement. The EUL also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
WHO’s assessment was made by regulatory experts globally and a technical advisory group in charge of performing the risk-benefit assessment for an independent recommendation on whether a vaccine can be listed for emergency use and, if so, under which conditions. In the case of the Sinovac-CoronaVac vaccine, the WHO assessment also included onsite inspections of the production facility.
Additionally, the company reported that the European Medicine Agency has initiated a rolling review of Sinovac’s COVID-19 vaccine CoronaVac, marking the first step in the process for CoronaVac to obtain European Union authorization.