COVID News: J&J, Pfizer, Moderna, AstraZeneca & More
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from J&J, Pfizer, Moderna, GSK, Medicago, AstraZeneca, Novavax, Valneva, Thermo Fisher Scientific, the World Health Organization, and the Coalition for Epidemic Preparedness Innovations.
Manufacturing and supply of COVID-19 vaccines and drugs
J&J’s COVID-19 Vaccine To Be Manufactured in Africa
Johnson & Johnson (J&J) has completed an agreement with Aspen SA Operations, a subsidiary of Aspen Pharmacare, a Durban, South Africa-based specialty pharmaceutical company, to enable its COVID-19 vaccine to be manufactured and made available in Africa.
The agreement enables Aspen, using COVID-19 vaccine drug substance supplied by J&J, to produce Aspen-branded finished vaccine and make doses available to the public sector in Africa, including all 55 member states of the African Union and multilateral entities supporting Africa’s COVID-19 vaccination drive, inclusive of the African Vaccine Acquisition Trust (AVAT), and the COVAX Facility, a global initiative for equitable access to COVID-19 vaccines and therapeutics.
To date (as reported on March 8, 2022), J&J has shipped more than 200 million COVID-19 vaccine doses to Africa through a combination of advance purchase agreements with the AVAT, South Africa and Gavi, on behalf of the COVAX Facility, along with government donations.
Source: Johnson & Johnson
Patent Lawsuit Filed Against Moderna for COVID-19 Vaccine
Arbutus Biopharma Corporation, a Warminster, Pennsylvania-based bio/pharmaceutical company, and Genevant Sciences, a Vancouver-based bio/pharmaceutical company, have filed a lawsuit in federal district court against Moderna and a Moderna affiliate seeking damages for patent infringement in the manufacture and sale of mRNA-1273, Moderna’s COVID-19 vaccine. The patents relate to nucleic acid-lipid particles and lipid vesicles, as well as compositions and methods for their use.
Genevant and Arbutus are not seeking an injunction or otherwise to impede the sale, manufacture, or distribution of the vaccine but are seeking compensation for Moderna’s use of the companies’ patented technology.
In December 2021, a federal appeals court dismissed Moderna’s appeal of a prior decision of the US Patent Trial and Appeal Board that held all claims of one patent (US Patent No. 8,058,069) to be patentable and certain claims of another patent (US Patent No. 9,364,435), both relating to relating to lipid formulations for nucleic acid delivery. Moderna had initiated inter partes review challenges against these patents in 2018 and 2019.
WHO Launches Biomfg Training Hub in South Korea
The World Health Organization (WHO) has established a global biomanufacturing training hub in South Korea to support all low- and middle-income countries in producing biologicals, such as vaccines, insulin, monoclonal antibodies, and cancer treatments.
The Korean government has offered a large facility outside Seoul that is already carrying out biomanufacturing training for companies based in the country and will now expand its operations to accommodate trainees from other countries. The facility will provide technical and hands-on training on operational and GMP requirements and will complement specific trainings developed by the WHO-supported mRNA vaccine technology transfer hub in South Africa. The WHO Academy will work with the Korean Ministry of Health and Welfare to develop a comprehensive curriculum on general biomanufacturing.
The move comes after the establishment of a global mRNA vaccine technology transfer hub in South Africa. Five more countries will also receive support from the global mRNA hub in South Africa: Bangladesh, Indonesia, Pakistan, Serbia and Vietnam. Argentina and Brazil were the first countries from the Americas to receive mRNA technology from the global hub in South Africa and joined the initiative in September 2021. Last month (February 2022), six African countries (Egypt, Kenya, Nigeria, Senegal, South Africa and Tunisia) joined the mRNA hub.
Source: World Health Organization
Updates on COVID-19 treatments and vaccines
EMA Committee Recommends Booster of Pfizer/BioNTech COVID Vaccine in Adolescents
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Comirnaty, Pfizer’s/BioNTech’s COVID-19 vaccine, as a booster dose (30 ug) in adolescents 12 through 17 years of age.
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 February 24, 2022). If the EC grants the variation, the decision will be immediately applicable to all 27 European Union member states, making booster vaccines available to everyone 12 years and older.
The COVID-19 vaccine booster for individuals 12 through 15 years of age was already granted emergency use authorization (EUA) by the US Food and Drug Administration (FDA) earlier this year (2022). The companies are also planning to file data with other regulatory authorities in the coming weeks (as reported on February 24, 2022).
Pfizer and BioNTech continue to supply the vaccine, including sufficient volume for boosters, under their existing supply agreement with the EC. The companies do not expect the introduction of booster doses for adolescents 12 through 17 years of age in the EU, if authorized, to impact the existing supply agreements in place with governments and international health organizations globally.
EMA Committee Recommends Moderna’s COVID-19 Vaccine in Children
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a variation to the conditional marketing authorization (CMA) for Spikevax, Moderna’s COVID-19 vaccine, to include a 50-µg two-dose series of in children ages six through 11 years of age. Following the CHMP’s positive opinion, the European Commission (EC) will make an authorization decision on the use of Spikevax in children ages six through 11 years of age.
The EMA has also recommended updates to the summary of product characteristics for the use of Spikevax in the EU. The booster dose of 50 µg indicated for individuals 18 years of age and older is now recommended at least three months following the second dose. This timing has been shortened from the previously approved timeframe of six months. The changes also include the possibility to administer a heterologous (mix-and-match) booster dose, such as Spikevax, following completion of primary vaccination with another authorized COVID-19 vaccine.
Canada OKs GSK’s, Medicago’s COVID-19 Vaccine
Health Canada, the pharmaceutical regulatory body of Canada, has granted approval for Covifenz, a plant-based COVID-19 vaccine from Medicago, a Quebec-based bio/pharmaceutical company, in individuals 18 to 64 years of age. Mitsubishi Tanabe Pharma is the majority parent company of Medicago.
The vaccine uses coronavirus-like particle technology with the vaccine composed of recombinant spike (S) glycoprotein expressed as virus-like particles co-administered with adjuvant supplied by GlaxoSmithKline.
The Canadian government has a contract with Medicago, the marketing authorization holder, to supply the COVID-19 vaccine. Medicago says it is committed to fulfilling this order as soon as possible (as reported on February 24, 2022). Antigen for the vaccine will be manufactured in Canada and North Carolina.
FDA Revises EUA for AstraZeneca’s COVID-19 Drug
The US Food and Drug Administration (FDA) has revised the emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination for the prevention of COVID-19, to change the initial dose for the authorized use in certain adults and pediatric patients.
The FDA states the dosing regimen was revised because available data indicate that a higher dose of Evusheld may be more likely to prevent infection by the COVID-19 Omicron subvariants BA.1 and BA.1.1 than the originally authorized Evusheld dose.
Source: US Food and Drug Administration
Pfizer Starts Final Oral COVID Drug Study in Children
Pfizer has initiated a Phase II/III study to evaluate its oral COVID-19 antiviral treatment, Paxlovid (nirmatrelvir and ritonavir), in non-hospitalized, symptomatic, pediatric participants with a confirmed diagnosis of COVID-19 who are at risk of progression to severe disease.
The Phase II/III trial is an open-label, multi-center, single-arm study in approximately 140 pediatric participants under 18 years of age. Initial enrollment features two cohorts; Cohort 1 includes participants aged 6 to 17 weighing at least 40 kg [88 lbs], and Cohort 2 includes those aged 6 to 17 weighing more than 20 kg [44 lbs] and less than 40 kg [88 lbs].
Pfizer says it is also working to develop an age-appropriate formulation for three additional planned cohorts of younger than 6 years old and will enroll the trial to include these younger age groups as data from Cohorts 1 and 2 and the new formulation are available.
Novavax’s COVID-19 Vaccine To Be Available in New Zealand
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has reported that the first doses of Nuvaxovid, its COVID-19 vaccine, will be available in New Zealand beginning the week of March 14, 2022.
New Zealand’s Medsafe, the medical regulatory body run by the New Zealand Ministry of Health, granted provisional approval of Nuvaxovid for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older last month (February 2022).
Valneva Gets EUA from Bahrain for COVID-19 Vaccine
Valneva, a Saint-Herblain, France-headquartered vaccine company, has received emergency use authorization (EUA) from Bahrain’s National Health Regulatory Authority for its COVID-19 vaccine candidate, VLA2001.
Valneva signed an advance purchase agreement with Bahrain in December 2021 for the supply of one million doses of VLA2001. The company expects to deliver the first shipments of VLA2001 to Bahrain at the end of this month (March 2022).
Valneva will be seeking a recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use for conditional approval of VLA2001 in Europe for primary immunization in adults aged 18-55 at the end of the first quarter of 2022.
UK, Japan Pledge Funds for CEPI’s COVID-19 Pandemic Plan
The UK and Japanese governments have pledged £160 million ($213 million) and $300 million, respectively, to the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private coalition seeking to speed up the development of vaccines, to advance its COVID-19 pandemic preparedness plan.
Endorsed by the G7 and G20 countries and termed the 100 Days Mission, the initiative includes a $3.5-billion, five-year plan to deliver R&D programs and accelerate the development of globally accessible vaccines against emerging diseases in 100 days.
The pledges from the UK and Japan came ahead of the UK government hosting CEPI’s Global Pandemic Preparedness Summit on March 7and 8, 2022 in London.
News on COVID-19 testing
Thermo Fisher Develops Medium for SARS-CoV-2 Virus
Thermo Fisher Scientific has developed a new viral transport medium for the collection and rapid inactivation of the SARS-CoV-2, the virus that causes COVID-19, and stabilizes viral RNA for transportation and use in in-vitro diagnostic testing procedures.
This single-use device can be used for sampling patients that are suspected of being infected with SARS-CoV-2 or sampling individuals for population screening for SARS-CoV-2.
The InhibiSURE Viral Inactivation Medium is now commercially available from Thermo Fisher in Europe, with plans for launch in other regions pending relevant regulatory approvals.
Source: Thermo Fisher Scientific