Pharma COVID Roundup: News from AstraZeneca, Pfizer, Moderna, TakedaBy
The latest on COVID-19 vaccines/drugs and manufacturing from AstraZeneca, Pfizer, Moderna, Takeda, Amgen, Novavax, Gates Foundation, the WHO, and Sinovac.
Manufacturing and supply of COVID-19 vaccines and drugs
AstraZeneca, EU Reach Settlement Over COVID-19 Vaccine Delivery
AstraZeneca and the European Commission have reached a settlement that ends legal proceedings over the execution of an advance purchase agreement for the delivery of AstraZeneca’s COVID-19 vaccine, Vaxzevria, to the European Union (EU).
Under the settlement agreement, AstraZeneca commits to deliver 60 million doses of its COVID-19 vaccine by the end of the third quarter 2021, 75 million by the end of the fourth quarter 2021, and 65 million by the end of the first quarter 2022. This will bring the total number of doses delivered to 300 million doses as agreed under the contract.
EU member states will be provided with regular delivery schedules, and capped rebates will apply in the event of any delayed doses.
Legal proceedings by the European Commission against AstraZeneca were initiated in April 2021. Court hearings were scheduled at end of September 2021.
To date (as reported on September 3, 2021), AstraZeneca reports that the company and its partners have supplied more than 1.1 billion doses of the company’s COVID-19 vaccine to over 170 countries; approximately two thirds have gone to low- and lower-middle-income countries.
Takeda, Moderna Issue Update Regarding COVID-19 Vaccine Recall
Takeda and Moderna, a bio/pharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, report an additional death following administration of Moderna’s COVID-19 vaccine.
Last week (September 1, 2021), Moderna and Takeda announced a plan to recall three lots of Moderna’s COVID-19 vaccine in Japan due to the presence of foreign particulates observed in unused vials of one lot. The particulates were determined to be stainless-steel containments from a production line of Rovi Pharma Industrial Services, a Madrid, Spain-based CDMO of the vaccine. Takeda is the distributor and marketing authorization holder of the vaccine in Japan.
The companies earlier had reported two deaths of individuals who had received the vaccine and are now reporting another death of an individual who received the vaccine. At this time (as reported on September 6, 2021), the companies say no causal link between previous deaths and Moderna’s COVID-19 vaccine has been identified, and there is no evidence that the vaccine poses any health hazard or significant safety risk. Takeda and Moderna, in cooperation with Japan’s Ministry of Health, Labor and Welfare, are further investigating.
Takeda To Manufacture Novavax’s COVID-19 Vaccine in Japan
Takeda has announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) will purchase 150 million doses of a COVID-19 vaccine (TAK-019) from Novavax’s, a Gaithersburg, Maryland-based clinical-stage vaccine company , subject to licensing and approval.
TAK-019, known outside Japan as NVX-CoV2373, is manufactured in Japan by Takeda. As part of a previously announced agreement with Novavax, Takeda is establishing the capability to manufacture TAK-019 at its facilities in Japan and aims to begin distribution in early 2022.
Novavax is licensing and transferring manufacturing technologies to enable Takeda to manufacture the vaccine antigen and is supplying its Matrix-M adjuvant to Takeda for fill-finish together with the antigen. Takeda is responsible for the Japanese clinical trial and regulatory submission to Japan’s Pharmaceuticals and Medical Devices Agency and will distribute TAK-019 in Japan should it be approved by the MHLW.
COVAX Drops Supply Forecast for COVID Vaccines
COVAX, a global initiative for equitable access to COVID-19 vaccines, has dropped its 2021 supply forecast for COVID-19 vaccines to low- and middle-income countries to 1.425 billion doses. In June (June 2021), it had expected to have access to 1.9 billion doses in 2021. Of the 1.4 billion doses in its revised forecast, approximately 1.2 billion will be available for the lower- income economies participating in the COVAX Advance Market Commitment (AMC), a financing instrument supporting participation of 92 low- and middle-income economies.
The 1.4 billion doses are enough to protect 20% of the population, or 40% of all adults, in all 92 AMC economies with the exception of India. Over 200 million doses will be allocated to self-financing participants. The COVAX milestone of two billion doses released for delivery is now expected to be reached in the first quarter of 2022.
Source: The World Health Organization
Updates on COVID-19 treatments and vaccines
EMA Assessing COVID-19 Vaccines Boosters from Pfizer and Moderna
The European Medicines Agency (EMA) has starting evaluating data for booster doses of Pfizer’s/BioNTech’s COVID-19 vaccine, Comirnaty, and Moderna’s COVID-19 vaccine, SpikeVax.
Separately, the EMA is also assessing data from the literature on the use of an additional, third dose of Comirnaty or SpikeVax in severely immunocompromised people.
Pfizer and BioNTech submitted a variation to the EMA requesting an update to their conditional marketing authorization (CMA) with data supporting a booster (third) dose of their COVID-19 vaccine in individuals 16 years of age and older. The same data had been submitted to the FDA and will be filed with other regulatory authorities in the upcoming weeks (as reported on September 6, 2021).
The EMA’s Committee for Medicinal Products for Human Use (CHMP) will carry out an accelerated assessment of data, including results from an ongoing clinical trial in which around 300 adults with healthy immune systems received a booster dose approximately six months after the second dose. The outcome of this evaluation is expected within the next few weeks (as reported on September 6, 2021), unless supplementary information is needed.
Last week (September 1, 2021), the FDA reported that its Vaccines and Related Biological Products Advisory Committee will hold a virtual meeting on September 17, 2021 to discuss additional doses of COVID-19 vaccines and specifically to discuss Pfizer’s/BioNTech’s supplemental biologics license application for administration of a third (booster) dose of Comirnaty.
Moderna also submitted a CMA with the EMA to evaluate a booster dose of its COVID-19 vaccine, SpikeVax, at the 50-µg dose level. A Phase II study was amended to include a booster dose six months after the second dose. Last week (September 1, 2021), Moderna initiated a submission to the FDA to evaluate a booster dose of its COVID-19 vaccine at the 50-µg dose level.
While these evaluations are ongoing, in a separate communication, the EMA and the European Center for Disease Prevention and Control (ECDC) highlighted their current position regarding additional and booster doses of COVID-19 vaccines. “Based on current evidence, there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population,” said the EMA and ECDC in a technical report released on September 1, 2021.
Although the EMA and the ECDC do not consider the need for COVID-19 vaccine booster doses to be urgent in the general population, the EMA continues to evaluate applications for a booster dose. The ECDC says it will update its technical report as the ECDC and the EMA continue to work together to collect and assess data that are becoming available on boosters and additional doses.
Gates Foundation, Exscientia in $35-M Pact for AI-Based COVID-19 Drugs
Exscientia, an Oxford, UK-based artificial intelligence (AI)-based drug development company, has signed a four-year, $35-million agreement with the Bill & Melinda Gates Foundation to discover and develop small-molecule therapeutics to treat COVID-19.
The collaboration will initially focus on developing broad-spectrum coronavirus agents (e.g., SARS-CoV-2 and its variants and Middle East Respiratory Syndrome), including accelerating Exscientia’s lead program, which targets the main protease (Mpro) of SARS-CoV-2, the virus responsible for COVID-19. Subsequently, the collaboration will expand to develop therapeutics for influenza and Paramyxoviridae, a family of RNA viruses, including the Nipah virus, with the potential to develop additional programs as identified by the joint team.
Exscientia will receive a $35-million equity investment from the Gates Foundation, subject to certain closing conditions, and will have the potential for additional grant funding. Exscientia will provide $35 million in matching contributions, through operations and funding for third-party activities
AstraZeneca, Amgen, Others Launch Post-Pandemic Respiratory Coalition
AstraZeneca, Amgen, the European Respiratory Society, a professional organization for respiratory healthcare, and the Global Allergy and Airways Patient Platform, an organization of patients and healthcare professionals, have launched the International Respiratory Coalition to address post-pandemic respiratory healthcare.
The coalition aims to support governments and healthcare systems in their recovery from COVID-19 by strengthening respiratory care. The coalition will seek to improve outcomes for people living with respiratory diseases by supporting the creation of national-level respiratory strategies and by building resilience in managing pandemics. Membership is open to organizations and individuals within the respiratory community.
Novavax Initiates Phase I/II Trial of COVID-19/Flu Combo Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has enrolled the first participants in a Phase I/II study to evaluate the safety and immunogenicity of a combination vaccine using Novavax’s seasonal influenza and COVID-19 vaccines.
The clinical trial combines Novavax’s recombinant protein-based COVID-19 vaccine, NVX-CoV2373, and its influenza vaccine, NanoFlu. The trial will be conducted in Australia at up to 12 study sites, with results expected during the first half of 2022.
FDA Declines EUA for Humanigen’s COVID-19 Drug Lenzilumab
The Food and Drug Administration (FDA) has declined the request for emergency use authorization (EUA) for lenzilumab, a drug by Humanigen, a Burlingame, California-based bio/pharmaceutical company, for treating COVID-19 in hospitalized patients. The company says it will continue regulatory processes underway seeking marketing authorization for lenzilumab to treat hospitalized COVID-19 patients in the UK and other territories.
Sinovac’s COVID-19 Vaccine OK’d for Emergency Use in Chile for Children
Sinovac Biotech, a Beijing-based bio/pharmaceutical company, reports that CoronaVac, its COVID-19 vaccine developed by its subsidiary, Sinovac Life Sciences, has received approval from the Public Health Institute of Chile or emergency use for children and adolescents aged between six and 17.
In May (May 2021), CoronaVac was approved for emergency use in the those aged from three to 17 years old in China. The COVID-19 vaccine was also approved for use in the those aged from 12 to 17 years old by Indonesian authorities in June (June 2021).