COVID News: Lilly, Pfizer/BioNTech, & More
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The latest on COVID-19 vaccines/drugs and manufacturing from Pfizer, BioNTech, Lilly, Sanofi, GSK, FDA, European Medicines Agency, CureVac, and Valneva. Highlights below.

Manufacturing and supply of COVID-19 vaccines and drugs
* Pfizer/BioNTech, US Gov’t in $3.2-Bn Supply Pact for COVID-19 Vaccine
* Lilly, US Gov’t in $275-M Supply Pact for COVID-19 Drug
* AstraZeneca, Oxford Biomedica Extend COVID-19 Vaccine Supply Pact
* CureVac Files Patent Case Against BioNTech for COVID-19 Vaccine

Updates on COVID-19 therapeutics and vaccines
* Pfizer Seeks Full Approval of COVID-19 Drug
* FDA, EMA Meet To Discuss Omicron-Subvariant COVID-19 Vaccines
* EC Authorizes Novavax’s COVID Vaccine in Adolescents
* Pfizer/BioNTech Report Results for COVID-19 Omicron Vaccine
* Sanofi/GSK Report Results for COVID-19 Omicron Vaccine
* EMA Advisory Committee Recommends Valneva’s COVID-19 Vaccine


Manufacturing and supply of COVID-19 vaccines and drugs

Pfizer/BioNTech, US Gov’t in $3.2-Bn Supply Pact for COVID-19 Vaccine
Pfizer and BioNTech have entered into a vaccine supply agreement, worth up to $3.2 billion, to provide the US government an additional 105 million doses (30 µg, 10 µg and 3 µg) of their COVID-19 vaccine. This may include adult Omicron-adapted COVID-19 vaccines, subject to authorization from the US Food and Drug Administration (FDA). The doses are planned to be delivered in the late summer 2022 and continue into the fourth quarter of this year (2022).

The US government will pay the companies $3.2 billion upon receipt of the first 105 million

doses and has the option to purchase up to 195 million additional doses to bring the total number of potential doses to 300 million.

The companies have begun manufacturing the Omicron-adapted vaccine candidates at risk so that they can begin deliveries upon authorization or approval and subsequent recommendation by the US Centers for Disease Control and Prevention.

Source: Pfizer and BioNTech


Lilly, US Gov’t in $275-M Supply Pact for COVID-19 Drug
Eli Lilly and Company has modified its purchase agreement with the US government to supply an additional 150,000 doses of bebtelovimab, a COVID-19 drug, for approximately $275 million.

The existing US government supply of the drug, including the new purchase, is expected to meet present demand through late August 2022. Delivery of doses will begin immediately (as reported on June 29, 2022) and be completed no later than August 5, 2022. The 2022 estimated value of this agreement is approximately $275 million, and the US government has an option for an additional 350,000 doses to be exercised no later than September 14, 2022.

Bebtelovimab is authorized for treating mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.

Source: Eli Lilly and Company


AstraZeneca, Oxford Biomedica Extend COVID-19 Vaccine Supply Pact
AstraZeneca has signed a new three-year master services & development agreement with Oxford Biomedica, an Oxford, UK-based company CDMO of gene and cell therapies, for potential future manufacturing of AstraZeneca’s COVID-19 vaccine. The new agreement expands and original agreement announced between the two companies in September 2020.

As part of the companies’ original agreement, the manufacture of COVID-19 vaccines at Oxford Biomedica’s 84,000-square-foot manufacturing facility is expected to complete in the last quarter of 2022. Under the new agreement, manufacturing of vaccines at Oxford Biomedica’s manufacturing facility will be available to AstraZeneca on an as needed basis beyond 2022.

In accordance with the terms of the original agreement and inclusive of revenues for batches already manufactured in the first half of 2022, Oxford Biomedica expects to receive aggregate revenues of approximately £30 million ($36 million) from AstraZeneca in 2022.

Source: Oxford Biomedica


CureVac Files Patent Case Against BioNTech for COVID-19 Vaccine
CureVac N.V., a bio/pharmaceutical company developing medicines based on messenger ribonucleic acid (mRNA), has filed a lawsuit in the German Regional Court in Düsseldorf against BioNTech and two of its subsidiaries, seeking compensation for infringement of a portfolio of CureVac’s intellectual property rights, used in the manufacture and sale of Comirnaty, BioNTech’s and Pfizer’s mRNA COVID-19 vaccine. CureVac says it does not seek an injunction nor intends to take legal action that impedes the production, sale, or distribution of Comirnaty by BioNTech and Pfizer.

The patents relate to the engineering of mRNA molecules, including sequence modifications to increase stability and enhance protein expression as well as mRNA vaccine formulations specific to SARS CoV-2 vaccines.

Source: CureVac


Updates on COVID-19 therapeutics and vaccines

Pfizer Seeks Full Approval of COVID-19 Drug
Pfizer has submitted a new drug application to the US Food and Drug Administration (FDA) for full approval of Paxlovid (nirmatrelvir tablets and ritonavir tablets) for treating patients who are at high risk for progression to severe illness from COVID-19. The drug is currently authorized for emergency use in the US for that indication.

Specifically, the drug is authorized for emergency use for treating mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Paxlovid is currently approved or authorized for conditional or emergency use in more than 65 countries to treat COVID-19 patients who are at increased risk for progressing to severe illness. As of the end of May 2022, Pfizer had shipped more than 12 million treatment courses of the drug to nearly 40 countries.

Source: Pfizer


FDA, EMA Meet To Discuss Omicron-Subvariant COVID-19 Vaccines

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) met late last month (June 2022) to publicly discuss whether a change to the current vaccine strain composition of COVID-19 vaccines for booster doses is necessary for the 2022 fall and winter seasons. The advisory committee voted in favor of including a SARS-CoV-2 Omicron component in COVID-19 vaccines that would be used for boosters in the US beginning in the fall of 2022.

The FDA has advised manufacturers seeking to update their COVID-19 vaccines to add an Omicron BA.4/5 spike protein component to the current vaccine composition to create a two component (bivalent) booster vaccine, so that the modified vaccines can potentially be used starting in early to mid-fall 2022.

“As we expect this coming year to be a transitional period when this modified booster vaccine may be introduced, we have not advised manufacturers to change the vaccine for primary vaccination since a primary series with the FDA-authorized and approved COVID-19 vaccines provides a base of protection against serious outcomes of COVID-19 caused by circulating strains of SARS-CoV-2,” said the FDA in a June 30, 2022, statement.

The FDA noted that vaccine manufacturers have already reported data from clinical trials with modified vaccines containing an Omicron BA.1 component and it has advised them that they should submit these data to the FDA for evaluation prior to any potential authorization of a modified vaccine containing an Omicron BA.4/5 component. Manufacturers will also be asked to begin clinical trials with modified vaccines containing an Omicron BA.4/5 component as the FDA notes that these data will be of use as the pandemic further evolves.

In addition, the FDA co-chaired a workshop with the European Medicines Agency (EMA) under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), a voluntary, executive-level entity of global medicines regulatory authorities, to identify principles to support the adaption of COVID-19 vaccines to better match Omicron variants of concern and ensure global regulatory alignment.

Participants from 18 ICMRA members and the World Health Organization (WHO), including the Vice-Chair of the WHO Technical Advisory Group on COVID-19 Vaccine Composition, engaged in the scientific discussions. ICMRA members and WHO agreed that authorized COVID-19 vaccines continue to offer protection against severe disease, hospitalization, and death and encouraged their use, where available, both as primary series and as booster doses. Global regulators also acknowledged that the continuous evolution of SARS-CoV-2 reduces the protection offered by the approved vaccines against infection and mild disease and outlined perspectives on further adaption of COVID-19 vaccines to Omicron subvariants.

 “Although the Omicron BA.4 and BA.5 subvariants seem to be taking over in many parts of the world, experience has shown that new variants may emerge rapidly and replace the currently circulating ones after short-lived waves,” said the EMA in a July 1, 2022, statement. “Preliminary data indicate that adapted mRNA vaccines, which incorporate an Omicron variant strain, can increase and extend protection, when used as a booster. Additionally, according to emerging data, a bivalent mRNA vaccine targeting two strains of SARS-CoV-2, one of which should be an Omicron strain, may provide some advantages in widening the immune response.”

The regulators indicated that according to emerging data, a bivalent mRNA vaccine targeting two strains of SARS-CoV-2, one of which should be an Omicron strain, may provide some advantages in widening the immune response. “Bivalent vaccines could be considered initially for use as boosters. Their use for primary vaccination might be supported in the future when further data become available,” said the EMA in its statement. “Vaccines which include other variants, for example the beta variant, might also be considered for use as boosters if clinical trial data demonstrate an adequate level of neutralization against Omicron and other variants of concern.”

The EMA said that evidence is still being collected, and the workshop participants stressed the need to review emerging clinical data from the ongoing clinical trials to determine the suitability of the adapted vaccines.

Source: US Food and Drug Administration and European Medicines Agency


EC Authorizes Novavax’s COVID Vaccine in Adolescents
The European Commission has granted Novavax, a Gaithersburg, Maryland-based vaccine company, expanded conditional marketing authorization (CMA) for Nuvaxovid, the company’s COVID-19 vaccine for adolescents aged 12 through 17. The company had previously received CMA for the vaccine individuals aged 18 and over in December 2021.

In addition to the EC’s expanded CMA, India has granted emergency use authorization for the vaccine for adolescents aged 12 through 17. The vaccine has not been authorized in the US.

Source: Novavax


Pfizer/BioNTech Report Results for COVID-19 Omicron Vaccine
Pfizer and BioNTech report positive results from a Phase II/Phase III study evaluating the safety, tolerability, and immunogenicity of two Omicron-adapted COVID-19 vaccine candidates: one monovalent and the other bivalent, a combination of Pfizer’s/BioNTech’s COVID-19 vaccine and a vaccine candidate targeting the spike protein of the Omicron BA.1 variant.

Data from the Phase II/III trial found that a booster dose of both Omicron-adapted vaccine candidates elicited a higher immune response against Omicron BA.1 as compared to the companies’ current COVID-19 vaccine. The immune response was seen across two investigational dose levels, 30 µg and 60 µg.

The results were shared with the US Food and Drug Administration and the European Medicines Agency in advance of discussions with the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the International Coalition of Medicines Regulatory Authorities (ICMRA) in late June (June 2022) (see related story above). The companies have also submitted additional data from their ongoing COVID-19 booster studies, including data on an additional dose of their current COVID-19 vaccine and Beta candidate.

Source: Pfizer and BioNTech


Sanofi, GSK Report Results for COVID-19 Omicron Vaccine
Sanofi and GlaxoSmithKline (GSK) report positive results from a Phase III trial for their COVID-19 vaccine candidate against an Omicron beta variant, an adjuvanted bivalent D614 and Beta (B.1.351) vaccine candidate. The vaccine candidate is based on Sanofi’s antigen and GSK’s adjuvant.

The companies reported that primary vaccination with the Beta-containing vaccine candidate delivered 64.7% efficacy against symptomatic infection in adults and 75.1% efficacy in participants previously infected with COVID-19.

Source: Sanofi


EMA Advisory Committee Recommends Valneva’s COVID-19 Vaccine
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for a COVID-19 vaccine in people from 18 to 50 years of age from Valneva, a Saint-Herblain, France-based vaccine company.

The European Commission (EC) will review the CHMP’s recommendation, and a decision on the marketing authorization application for the vaccine candidate is expected shortly (as reported on June 23, 2022). If granted by the EC, the marketing authorization would be valid in all European Union member states as well as in Iceland, Liechtenstein, and Norway. Earlier this month (June 2022), Valneva proposed a new supply plan to the EC following the EC’s notification that it intends to terminate its advanced purchase agreement for Valneva’s COVID-19 vaccine candidate. Separately, the company reached a settlement agreement with the UK following the UK’s termination of its supply pact with the company.

Source: Valneva