COVID News: Pfizer, Moderna, AstraZeneca & MoreBy
The latest on COVID-19 vaccines/drugs and manufacturing from Pfizer, Moderna, AstraZeneca, Novavax, GSK, and CureVac.
Manufacturing and supply of COVID-19 vaccines and drugs
Pfizer to Supply UNICEF with Oral COVID-19 Drug
Pfizer has entered into an agreement with UNICEF to supply up to 4 million treatment courses of its oral COVID-19 treatment, Paxlovid (nirmatrelvir tablets and ritonavir tablets), to 95 low- and middle-income countries, pending authorization or approval.
This includes all low- and lower-middle-income countries and some upper-middle-income countries in Sub-Saharan Africa as well as countries that have transitioned from lower-middle to upper-middle-income status in the last five years, accounting for approximately 53% of the world’s population.
Pfizer expects supply to be available to support orders in April 2022, and supply will continue throughout 2022, pending regulatory authorization or approval and according to country needs. All low- and lower-middle-income countries will be offered the treatment courses at the not-for-profit price while upper-middle-income countries will pay the price defined in Pfizer’s tiered pricing approach.
Moderna To Supply COVID-19 Vaccine Booster to Switzerland
Moderna has entered into a new supply agreement with the Swiss federal government for seven million doses of its COVID-19 booster vaccine for anticipated delivery in 2023 and an additional option of seven million doses for delivery in 2023 and 2024.
These doses are in addition to the seven million doses of Moderna’s COVID-19 booster vaccine that are scheduled for supply to Switzerland in the second half of 2022, which the government exercised its option to purchase in December 2021.
Updates on COVID-19 treatments and vaccines
Pfizer, BioNTech Get Expanded EUA for COVID-19 Booster
The US Food and Drug Administration (FDA) has expanded the emergency use of Pfizer’s and BioNTech’s COVID-19 vaccine to include a second booster dose in adults ages 50 years and older who have previously received a first booster of any authorized COVID-19 vaccine.
The FDA also has authorized a second booster dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine. The additional booster is to be administered at least four months after the first booster and is the same formulation and strength as prior Pfizer/BioNTech COVID-19 vaccine doses.
Moderna Gets FDA OK for 2nd COVID-19 Vaccine Booster
Moderna has received an amended emergency use authorization from the US Food and Drug Administration (FDA) for a second booster dose of its COVID-19 vaccine, mRNA-1273, at the 50- µg dose level in adults 50 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines and in adults 18 years of age and older with certain kinds of immunocompromise.
Separately, Moderna has reported positive interim data from a Phase II/III study of the mRNA-1273 in children six months to under two years and two years to under six years of age. The data showed a robust neutralizing antibody response in both age groups after a 25-µg two-dose primary series of mRNA-1273 along with a favorable safety profile.
Based on these data, Moderna says it will submit a request for authorization of a 25-μg two-dose primary series of mRNA-1273 for children six months to under six years of age to the FDA, European Medicines Agency, and other global regulators in the coming weeks (as reported on March 23, 2022).
AstraZeneca’s COVID-19 Drug Approved in EU
AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorization in the European Union (EU) for the prevention of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.
The recommended dose of Evusheld in Europe is 150 mg of tixagevimab and 150 mg of cilgavimab, administered as two separate sequential intramuscular injections.
Evusheld is authorized for emergency use for pre-exposure prophylaxis of COVID-19 in the US and has been granted conditional marketing authorization by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for pre-exposure prophylaxis of COVID-19. Additionally, there are a number of countries across Europe that have agreements in place to provide Evusheld.
Novavax Gets EUA for COVID-19 Vaccine in Adolescents in India
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, and the Serum Institute of India (SII), a Pune, India-based vaccine manufacturer, report that the Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) for Novavax’s protein-based COVID-19 vaccine, NVX-CoV2373, for adolescents aged between 12 and 18 years. The vaccine is manufactured and marketed in India by SII under the brand name Covovax.
Covovax is the fourth vaccine to receive EUA from the DCGI for use among adolescents 12 and older. DCGI initially granted EUA for Covovax for adults 18 years old and above in December 2021. In addition, Covovax has received emergency use listing from the World Health Organization, as well as EUA in Indonesia, the Philippines, and Bangladesh.
GSK, CureVac Start Phase I Trial of COVID-19 Vaccine Candidate
CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics and vaccines, has initiated a Phase I study of CV2CoV, its COVID-19 second-generation mRNA vaccine candidate, developed in collaboration with GlaxoSmithKline (GSK).
The clinical trial is expected to provide data to further evaluate the performance of CureVac’s second-generation mRNA backbone, which the company says has the potential to be applied in future vaccines against COVID-19 variants and other pathogens.
The Phase I dose-escalation study is being conducted at clinical sites in the US and is expected to enroll up to 210 healthy adults to evaluate the safety, reactogenicity and immunogenicity of CV2CoV in the dose range of 2 to 20 µg. Data results from the Phase I study are expected in the second half of 2022.