The latest on COVID-19 vaccines/drugs and manufacturing from Pfizer, BioNTech, AstraZeneca, Gilead Sciences, IDT Biologika, Valneva, and Clover Biopharmaceuticals. Highlights below.

Manufacturing and supply of COVID-19 vaccines and drugs
* IDT Biologika, Valneva End COVID-Vaccine Mfg Pact
* Clover’s CDMO Gets EU GMP Certificate
Updates on COVID-19 Vaccines and Therapeutics
* EMA Committee Recommends Full Approval of Pfizer’s, BioNTech’s COVID Vaccine and Boosters
* EU Gives Full Approval to AstraZeneca’s COVID Combo Drug
* EMA Committee Recommends OK for Pediatric Use of Gilead’s COVID Drug

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Manufacturing and supply of COVID-19 vaccines and drugs

IDT Biologika, Valneva, End COVID-Vaccine Mfg Pact
IDT Biologika, a CDMO of vaccines and biopharmaceuticals, and Valneva, a Saint-Herblain, France-based vaccine company, have agreed to terminate their collaboration under which IDT Biologika produced Valneva’s COVID-19 vaccine.

Valneva suspended manufacturing of the vaccine due to a reduced order for the vaccine from the European Commission, which the company announced in July 2022. Valneva will pay IDT up to EUR 36.2 million ($35.7 million) in cash and the equivalent of EUR 4.5 million ($4.4 million) in kind, in the form of specified equipment purchased by Valneva.

Valneva has started to deliver doses of the vaccine to European Union member states who ordered the vaccine and is retaining inventory for potential additional supply to these member states should demand increase. The company is also continuing discussions with various other governments, with the aim to deploy approximately eight to ten million doses of remaining inventory into international markets in the next six to twelve months (as reported on September 16, 2022).

Source: Valneva and IDT Biologika

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Clover’s CDMO Gets EU GMP Certificate
Clover Biopharmaceuticals, a Chengdu, China-based bio/pharmaceutical company, reports that its CDMO has received a European Union Good Manufacturing Practice (EU GMP) certificate for the production of Clover’s lead COVID-19 vaccine candidate, SCB-2019. The EU GMP certificate is in connection with Clover’s regulatory submission to the European Medicines Agency, and follows a successful inspection of the CDMO site by the Ireland Health Products Regulatory Authority

Clover is working toward completing regulatory submissions in the second half of 2022 to the China National Medical Products Administration, the European Medicines Agency, and the World Health Organization for SCB-2019.

Source: Clover Biopharmaceuticals

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Updates on COVID-19 Vaccines and Therapeutics

EMA Committee Recommends Full Approval for Pfizer’s, BioNTech’s COVID Vaccine and Boosters
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended converting the conditional marketing authorization for Comirnaty, Pfizer’s and BioNTech’s COVID-19 vaccine, to standard marketing authorization for all authorized indications and formulations, authorized in the European Union (EU), including the companies’ Omicron-adopted boosters. The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision soon (as reported on September 16, 2022).

The conversion, if approved by the EC, applies to all existing indications and formulations o Comirnaty (the companies’ original COVID-19 vaccine), authorized in the EU, including the company’s Omicron-adopted bivalent vaccines (Comirnaty Original/Omicron BA.1 and Comirnaty Original/Omicron BA.4-5) as booster doses for individuals aged 12 and older in the EU.

In a separate development, the CHMP also recommended approval for Comirnaty as a 10-µg booster (third) dose given to children 5 through 11 years of age. Comirnaty 10-µg was authorized in the EU in November 2021 as a two-dose primary series for children 5 through 11 years of age. The EC will review the CHMP opinion and if marketing authorization is granted, the decision will be applicable to all 27 EU member states.

Source: Pfizer and BioNTech

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EU Gives Full Approval to AstraZeneca’s COVID Combo Drug
The EU has approved AstraZeneca’s Evusheld (tixagevimab and cilgavimab) a long-acting antibody combination, for treating COVID-19 in adults and adolescents (aged 12 years and older weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID‑19.

Evusheld was granted marketing authorization in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents earlier this year (2022) and is available in a majority of countries in Europe.

AstraZeneca reports that Evusheld has been shown to retain in vitro neutralization of Omicron BA.5, which is currently the dominant SARS-CoV-2 variant in Europe. Evidence generated to date (as reported on September 20, 2022) has demonstrated significantly lower rates of symptomatic COVID-19 and/or hospitalization/death for immunocompromised patients receiving Evusheld compared to control arms. This includes evidence collected while Omicron BA.5, BA.4, BA.2, BA.1 and BA.1.1 were circulating.

Source: AstraZeneca

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EMA Committee Recommends OK for Pediatric Use of Gilead’s COVID Drug
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion to extend the indication of Gilead Sciences’ Veklury (remdesivir), an antiviral drug for treating COVID-19 drug, to include pediatric use. 

The European Commission (EC) will review the CHMP recommendation, and if adopted, Veklury will be able to treat pediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19 and pediatric patients (4 weeks of age and older and weighing at least 3 kg) with SARS-CoV-2 with pneumonia who require supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment).

The drug is currently authorized for both the treatment of COVID-19 in adult patients who do not require supplemental oxygen and are at increased risk of developing severe COVID-19, as well as adults and adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment).

In a separate development, the World Health Organization updated its guideline to now recommended the drug for use in both non-severe cOVID-19 patients at the highest risk of hospitalization and patients with severe COVID-19.

Source: Gilead Sciences (CHMP recommendation) and Gilead Sciences (WHO update)