COVID Roundup: Pfizer, Moderna, J&J & More

The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Pfizer, Moderna, Johnson & Johnson, Merck & Co., GlaxoSmithKline, Novavax, Valneva, Emergex, and Samsung Biologics.

Manufacturing and supply of COVID-19 vaccines and drugs

Moderna, Revises COVID-19 Vaccine Supply Pact with UK
Moderna has announced a revised supply agreement with the UK government for up to 60 million doses of its COVID-19 vaccine, which may include authorized booster vaccine candidates, with up to 29 million doses expected to be delivered in 2022 and up to 31 million doses expected to be delivered in 2023.

Under the agreement, the UK government retains a right to increase its purchases in 2022 and 2023 by up to 20% above the contracted volumes, or to decrease by the same amount.

Source: Moderna

J&J Plans COVID-19 Vaccine to Lower-Income Countries
Johnson & Johnson (J&J) has announced plans to donate almost 100 million doses of its COVID-19 vaccine to lower-income countries through the COVAX Facility, a global initiative for equitable access to COVID-19 vaccines and treatments.

Supported by the European Commission (EC), Norway and Iceland (collectively known as Team Europe) are providing these doses under an agreement signed recently by the government of Belgium (acting on behalf of Team Europe), Gavi, a global vaccine alliance, and J&J. The agreement will enable doses of the company’s vaccine to be shipped directly to COVAX for the benefit of low- and middle-income countries through the remainder of this year (2021) and into early 2022.

Recipient countries are determined by Gavi, who together with Alliance partners UNICEF and the World Health Organization, will work alongside receiving governments on country readiness and the transfer of these doses. J&J will provide certain supply-chain and logistical support to ensure donated vaccines can be delivered to recipient countries. First shipments of doses bgan  arriving late last month (November 2021).

J&J has committed to providing its vaccine on a not-for-profit basis globally for emergency pandemic use and is making available up to 500 million doses of its vaccine to the COVAX Facility through 2022. This is in addition to donations by the European Union and others of J&J’s COVID-19 vaccine.

Separately, J&J has reached an advanced stage in its discussions for a potential licensing agreement for its COVID-19 vaccine with Aspen SA Operations, a subsidiary of Aspen Pharmacare, a global multinational specialty pharmaceutical company. The parties will continue to work toward a definitive agreement that builds on their existing manufacturing collaboration to enable the COVID-19 vaccine to be manufactured and sold by an African company in Africa.

The license under discussion would enable Aspen, using COVID-19 vaccine drug substance supplied by J&J, to produce Aspen-branded finished vaccine for sale to public sector markets in Africa through transactions with national governments of African Union member states and certain multilateral entities serving Africa, including the African Vaccine Acquisition Trust (AVAT), Gavi, COVAX and UNICEF.

Separately, late last month (November 24, 2021), Health Canadaprovided full approval to J&J’s COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.

Source: Johnson & Johnson (donation), Johnson & Johnson (Canada), Johnson & Johnson (licensing), and Aspen Pharmacare

Samsung Biologics in COVID-19 Vaccine Mfg Pact
Samsung Biologics, an Incheon, South Korea-based contract biologics manufacturer, has entered into an agreement with GreenLight Biosciences, a Medford, Massachusetts-based biotechnology company, in which Samsung Biologics will manufacture GreenLight’s messenger RNA COVID-19 vaccine candidate at commercial scale.

The partnership aims to accelerate production of GreenLight’s COVID-19 vaccine candidate for Phase III clinical trials and, subject to regulatory approval, commercial sales. The collaboration with Samsung will use GreenLight’s existing manufacturing process, with technology transfer from GreenLight to Samsung starting immediately (as reported on November 25, 2021).

Source: GreenLight Biosciences and Samsung Biologics

Valneva in COVID-19 Vaccine Supply Pacts
Valneva, a Saint-Herblain, France-headquartered vaccine company, has entered into agreements with the European Commission (EC) and IDT Biologika, a contract manufacturer of vaccines and biopharmaceuticals, for its inactivated COVID-19 vaccine candidate, VLA2001

In the first agreement, Valneva has signed an advance purchase agreement with the EC to supply up to 60 million doses of VLA2001 over two years (as reported on November 23, 2021). Under the agreement, following final review of the volumes by each of the EU member states, Valneva expects to deliver 24.3 million doses during the second and third quarters of 2022, subject to approval of VLA2001 by the European Medicines Agency. The EC has the option to increase this initial firm purchase order up to a total of 60 million doses, the remainder of which would be delivered in 2023.

Separately, Valneva and IDT Biologika have entered into a collaboration for the production of VLA2001, under which IDT Biologika will produce VLA2001’s drug substance at its facilities in Dessau-Roßlau, Germany, in addition to Valneva’s manufacturing site in Livingston, Scotland.

Valneva plans to operate a combination of external and internal production of VLA2001 and says it will further review its manufacturing plans based on demand.

Source: Valneva (EU), Valneva (IDT Biologika) and IDT Biologika

Updates on COVID-19 treatments and vaccines

FDA OKs COVID-19 Vaccine Boosters in All Adults
The US Food and Drug Administration (FDA) has expanded the emergency use authorizations (EUA) for a single booster dose respectively of Moderna’s and Pfizer’s/BioNTech’s COVID-19 vaccines for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. The FDA had previously authorized booster doses in certain patient groups.

In turn, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices  has also expanded recommendations for booster shots to include all adults ages 18 years and older who received a Pfizer/BioNTech or Moderna COVID-19 vaccine at least six months after their second dose.

Pfizer and BioNTech say that they continue to supply the COVID-19 vaccine, including sufficient volume for boosters, under their existing supply agreement with the US government, which continues through April 2022.

Source: US Food and Drug Administration, Centers for Disease Control and Prevention, Pfizer, BioNTech, Moderna (FDA), and Moderna (CDC)

EU in Positive Opinion for Pfizer’s COVID-19 Vaccine in Children  
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the administration of Pfizer’s and BioNTech’s COVID-19 vaccine, Comirnaty, in children aged 5 to 11.

The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the conditional marketing authorization in the near future (as reported on November 25, 2021). If the EC grants the variation regarding a vaccination in this age group, the decision will be immediately applicable to all 27 European Union member states. If approved, Comirnaty will be the first COVID-19 vaccine authorized in the European Union for children in this age group.

Pfizer and BioNTech continue to supply the COVID-19 vaccine, including sufficient volume for pediatric doses, under their existing supply agreement with the EC. The companies say they do not expect the introduction of pediatric doses in the US and the European Union, if authorized, to impact existing supply agreements in place with governments and international health organizations globally.

Pfizer and BioNTech have submitted requests for authorization of their COVID-19 vaccine in this age group to other regulators globally. The companies say they expect initial pivotal data from their ongoing clinical trial in children age two to under five years of age this quarter (fourth quarter of 2021), and in children aged six months to under two years of age in the first quarter 2022, with full data readouts to follow.

Source: Pfizer and BioNTech

Merck & Co./Ridgeback Report Lesser Efficacy of Oral COVID Drug
Merck & Co. and Ridgeback Biotherapeutics, a Miami, Florida-based bio/pharmaceutical company, report updated efficacy results from a Phase III study of molnupiravir, an investigational oral antiviral medicine for treating mild-to-moderate COVID-19 in adults, in which the drug provided lesser efficacy than what was previously reported.

In this study population, molnupiravir reduced the risk of hospitalization or death at a relative risk reduction of 30%. As previously reported, at the planned interim analysis, molnupiravir reduced the risk of hospitalization or death at a relative risk reduction of 48%.

Molnupiravir has been authorized for use in the UK. The US Food and Drug Administration is reviewing Merck & Co.’s application for emergency use authorization; an FDA advisory committee issued a positive opinion for the drug earlier this month (December 2021). The European Medicines Agency is reviewing Merck & Co.’s application for marketing authorization following a positive scientific opinion.

Source: Merck & Co.

GSK Reports Preclinical Data on COVID-19 Drug Against Omicron Variant
GlaxoSmithKline (GSK) and Vir Biotechnology, a San Francisco-based bio/pharmaceutical company, have announced preclinical data demonstrating that its COVID-19 drug, sotrovimab, retains activity against mutations of the new Omicron SARS-CoV-2 variant (B.1.1.529), including those found in the binding site of sotrovimab.

The companies are completing in vitro pseudo-virus testing to confirm the neutralizing activity of sotrovimab against the combination of all the Omicron mutations with the intent to provide an update by the end of 2021.

Source: GlaxoSmithKline

Novavax Files for Interim Authorization of COVID-19 Vaccine in Singapore
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has filed for interim authorization of NVX-CoV2373, its COVID-19 vaccine, with the Singapore Health Sciences Authority under the Pandemic Special Access Route.

The filing includes clinical data from two pivotal Phase III clinical trials: (1) a trial of 30,000 participants in the US and Mexico and demonstrated 100% protection against moderate and severe disease and 90.4% efficacy; and (2) a trial of 15,000 participants in the UK that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall.

Novavax and Serum Institute of India (SII), a Pune, India-based vaccine manufacturer, recently received emergency use authorization (EUA) for the COVID-19 vaccine in Indonesia and the Philippines, and the companies have filed for EUA in India and for emergency use listing with the World Health Organization (WHO). Novavax also announced regulatory filings for its vaccine in the UK, Australia, New Zealand, Canada, the European Union and with WHO.

Source: Novavax

Emergex Initiates Phase I Trial of COVID-19 Vaccine
Emergex Vaccines, an Abingdon, UK-based company developing synthetic T-Cell priming vaccines, has received approval to initiate a Phase I clinical trial to evaluate its COVID-19 vaccine candidate. The first patient is anticipated to receive their first dose of the COVID-19 vaccine candidate at the start of January 2022.

Source: Emergex Vaccines

News on COVID-19 testing

FDA OKs, Three OTC COVID-19 Antigen Diagnostic Tests
The US Food and Drug Administration (FDA) has authorized three over-the-counter (OTC) COVID-19 antigen diagnostic tests for people age 14 years or older with a self-collected nasal swab sample or people age two years or older when an adult collects the nasal swab sample.

The three authorized OTC tests are: (1) The InBios SCoV-2 Ag Detect Rapid Self-Test; (2) The Access Bio CareStart COVID-19 Antigen Home Test; and (3) The Becton, Dickinson and Company BD Veritor At-Home COVID-19 Test. Full details of each test can be found here.

Source: US Food and Drug Administration