Pharma COVID Roundup: News from Pfizer, AstraZeneca, GSK, SanofiBy
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Pfizer, AstraZeneca, GSK, Sanofi, Novavax, SK bioscience, Thermo Fisher, Sharp, and Innova.
Manufacturing and supply of COVID-19 vaccines and drugs
Novavax in Pact with SK Bioscience, Korean Gov’t for COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has signed a non-binding memorandum of understanding with the Ministry of Health and Welfare of Korea and SK bioscience, a vaccine developer and manufacturer, to explore further cooperation in the development and manufacturing of vaccines, including NVX-CoV2373, Novavax’s COVID-19 vaccine.
The memorandum of understanding builds on an existing manufacturing and licensing collaboration that is intended to provide broad and equitable access to NVX-CoV2373 in the Republic of Korea and globally.
Novavax and SK bioscience agreed to potentially explore the development of new vaccine products, including COVID-19 variant vaccines, and/or an influenza-COVID-19 combination vaccine. They will continue to collaborate in manufacturing of the vaccines using SK Bioscience’s facility, with support from the Korean government.
SK bioscience initiated the rolling submission process for NVX-CoV2373 in collaboration with Novavax to South Korea’s Ministry of Food and Drug Safety in April (April 2021).
Separately, Novavax announced its participating in a mix-and-match (vaccine interchangeability) COVID-19 vaccine booster trial that is being led by the University Hospital Southampton NHS Foundation Trust and other UK National Institute for Health Research sites.
This study will assess the safety and immune response against COVID-19 provided by these various vaccine schedules. The study will begin during the first week of June (June 2021) and is receiving support from the UK Government Vaccines Taskforce and Department of Health and Social Care.
Updates on COVID-19 treatments and vaccines
FDA Authorizes GSK’s, Vir Biotechnology’s COVID-19 Drug
GlaxoSmithKline (GSK) and Vir Biotechnology, a San Francisco-based clinical-stage biopharmaceutical company, have received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) and a positive scientific opinion from the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) for sotrovimab, a monoclonal antibody for treating adults and adolescents with COVID-19.
The FDA’s EUA applies to adults and pediatric patients (12 years of age and older weighing at least 40 kilograms [about 88 pounds]) 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.
Sotrovimab is continuing to be studied in ongoing clinical trials. An analysis of safety and efficacy data at Day 29 for the full population from a Phase III trial is expected as early as the first half of 2021. GSK and Vir plan to submit a biologics license application to the FDA in the second half of 2021.
The CHMP’s review took place in parallel to the EMA’s ongoing rolling review process, which is used to speed up the formal marketing application assessment of a promising medicine during a public health emergency. The rolling review will continue until enough evidence is available to support a formal marketing authorization application. EU member states can use the CHMP positive scientific opinion when making national decisions about the early use of sotrovimab prior to EMA marketing authorization.
Discussions with global regulators regarding authorizations in additional countries continue to advance.
Pfizer Studies Combo of Pneumococcal Vaccine and COVID-19 Vaccine
Pfizer reports that the first enrolled subjects have received their immunizations as part of a new study in adults ages 65 or older exploring the co-administration of the company’s 20-valent pneumococcal conjugate vaccine (20vPnC) candidate following a booster dose of the Pfizer/BioNTech COVID-19 vaccine.
The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines.
The trial will include 600 adults who will be recruited from the Phase III Pfizer/BioNTech COVID-19 vaccine trial and will have received their second dose of the vaccine at least six months prior to entering the co-administration study.
AstraZeneca’s COVID-19 Vaccine Authorized for Emergency Use in Japan
AstraZeneca’s COVID-19 vaccine, Vaxzevria, has been granted a special approval for emergency use in Japan for active immunization of individuals aged 18 years and older to prevent COVID-19.
Production of the vaccine in Japan is already underway, and the first doses are expected to be available in the coming weeks (as reported on May 21, 2021).
The vaccine has been granted a conditional marketing authorization or emergency use in more than 80 countries and has received Emergency Use Listing from the World Health Organization, which accelerates the pathway to access in up to 142 countries through the COVAX Facility, a global initiative for equitable access to COVID-19 vaccines.
Sanofi, GSK Initiate Global Phase III Study of COVID-19 Vaccine
Sanofi and GlaxoSmithKline (GSK) have initiated enrollment in a Phase III study to assess their adjuvanted recombinant-protein COVID-19 vaccine candidate.
The global Phase III study will include more than 35,000 volunteers aged 18 and older from several countries, including sites in the US, Asia, Africa, and Latin America. The primary endpoint of the study is the prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults, with secondary endpoints being the prevention of severe COVID-19 disease and prevention of asymptomatic infection.
Following encouraging interim results from a recent Phase II study, the companies will also begin clinical studies in the coming weeks (as reported on May 27, 2021) to assess the ability of the vaccine candidate to generate a strong booster response regardless of initial vaccine platform received.
Pending positive Phase III outcomes and regulatory reviews, the vaccine could be approved or authorized in the fourth quarter of 2021. Manufacturing will begin in the coming weeks (as reported on May 27, 2021) to enable rapid access to the vaccine should it be approved.
CEPI To Provide $173.4 M To Fund SK bioscience’s COVID-19 Vaccine
The Coalition for Epidemic Preparedness Innovations (CEPI), a public–private coalition that seeks to derail epidemics by speeding up the development of vaccines, and SK bioscience, a vaccine developer and manufacturer, have expanded their partnership to develop a vaccine candidate against SARS-CoV-2, including variants of concern, in a deal worth up to $173.4 million.
CEPI will provide up to $173.4 million in additional funding to SK bioscience to support its COVID-19 vaccine development program. Of this funding, $41 million will be provided in the form of a forgivable loan that is repayable based on sales of the vaccine and will be used to secure raw materials needed for manufacturing. This brings CEPI’s total investment in SK bioscience to $210.1 million.
CEPI’s funding will support Phase III clinical trials of SK bioscience’s recombinant protein vaccine candidate (GBP510). The GBP510 candidate, which is currently undergoing Phase I/II testing in the Republic of Korea, is manufactured using a nanoparticle platform.
SK bioscience plans to submit an investigational new drug for multi-national Phase III clinical trials to Korea’s Ministry of Food and Drug Safety and other relevant regulatory authorities in the first half of 2021 and is aiming for commercialization within the first half of next year (2022) though expedited approval process such as emergency use license.
In response to SARS-CoV-2 variants, CEPI will also be funding further adaptation and clinical testing of the GBP510 candidate for use against variants of concern, such as the B.1.351 variant (first identified in South Africa). In parallel, CEPI will also support further scale-up of SK biosciences’ manufacturing to full commercial scale, potentially enabling the annual production of hundreds of millions of doses.
CEPI previously invested up to $10 million toward the cost of Phase I/II trials of in SK Bioscience’s vaccine candidate in December 2020, followed by an additional $26.7 million to begin adaptation against variants and support scale-up of manufacturing in March 2021.
Syngene, Dyadic in Pact for COVID-19 Vaccine Against Variants
Syngene International, a Biocon subsidiary and Bangalore, India-headquartered contract research organization, and Dyadic International, a Jupiter, Florida-based bio/pharmaceutical company, have entered into a collaboration to develop a COVID-19 vaccine against emerging variants of concern.
Dyadic will work with Syngene to develop a vaccine candidate to immunize people against current and future variants of the COVID-19 virus that can be manufactured at large scale using Dyadic’s proprietary C1-cell protein production platform.
Dyadic previously expanded its partnership with Medytox, a bio/pharmaceutical company, to co-develop vaccines in the Republic of Korea and multiple Southeast Asian countries.
FDA Updates Guidance for COVID-19 Vaccine Authorization Process
The US Food and Drug Administration (FDA) has updated its guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, to include a new section that clarifies how the agency intends to prioritize review of emergency use authorization (EUA) requests for the remainder of the COVID-19 public health emergency.
The FDA says for the remainder of the current pandemic it may decline to review and process further EUA requests other than those for vaccines whose developers have already engaged with the agency as described in its guidance.
Source: US Food and Drug Administration
News on COVID-19 testing
Innova, Sharp Partner for Rapid COVID-19 Tests
Innova Medical Group, a Pasadena, California-based provider of rapid antigen tests, has partnered with Sharp Packaging, a provider of contract packaging and clinical supply services, to support production of millions of Innova’s COVID -19 lateral flow tests.
Innova will invest in Sharp’s facility in Rhymney, Caerphilly, South Wales, UK for packaging machinery. Delivery of the machinery is targeted for the end of June, with production expected to begin in early July (July 2021).
The equipment will support production of 1.2 million rapid COVID-19 tests daily. Innova says it plans to boost UK local production capacity through further investments later this year (2021)
Thermo Fisher’s COVID-19 Test Valid for Incoming Travel to the UK
Thermo Fisher Scientific’s TaqPath COVID-19 CE-IVD RT PCR Kit has been independently validated as meeting the performance characteristics for quarantine protocol testing required for international travelers arriving in the UK.
The UK has instituted quarantine rules for travelers entering the country that vary depending on the country of departure, but most people will be legally required to quarantine for 10 days upon arrival. On days two and eight of their isolation, those travelers are obliged to take a PCR test to monitor for an active SARS-CoV-2 infection. Thermo Fisher’s TaqPath kit is now permitted to be used by laboratories and clinics in that surveillance.
The TaqPathCOVID-19 CE-IVD RT PCR Kit is a diagnostic that contains both the assays and controls needed for the real-time PCR detection of RNA from SARS-CoV-2, the virus that causes COVID-19. The kit received initial CE-IVD approval in March 2020 and is compatible with most widely used PCR instruments.
Source: Thermo Fisher Scientific
Fujifilm Wako Pure Chemical Launches Reagent for COVID Testing
Fujifilm Wako Pure Chemical Corporation has launched a research reagent for detecting mutations of SARS-CoV-2, the virus that causes COVID-19.
The E484Q Mutation Detection Kit is a detection reagent for SARS-CoV-2 mutation, developed using the company’s proprietary design method. This research reagent is capable of detecting E484Q mutation, found in the Indian variant, at a high sensitivity from SARS-CoV-2 positive sample. Furthermore, it can be combined with the existing L452R mutation detection kit, to identify the Indian variant that contains both L452R and E484Q mutations.
Its combined use with the L452R, N501Y, and E484K mutation detection kits makes it possible to identify the UK variant (N501Y), South African/Brazilian variants (N501Y, E484K), Indian/California variants (L452R), and Indian variant (L452R, E484Q).
This kit is used in the Japanese government’s COVID-19 testing programs. Additionally, the company is engaged in research and development for new variants and says it will expand the lineup of mutation detection kits.