Pharma COVID Roundup: News from J&J, Moderna, Novavax, CureVac
The latest on manufacturing, potential treatments/vaccines, and testing for COVID-19 with news from J&J, Moderna, Thermo Fisher, Novavax, CureVac, Sinovac, and Celltrion.
Manufacturing and supply of COVID-19 vaccines and drugs
Moderna in Supply Pacts with Taiwan, Columbia for COVID-19 Vaccine
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has announced two separate supply agreements with the governments of Taiwan and Colombia for its COVID-19 vaccine.
The supply agreement with the government of Taiwan is for 5 million doses, and the agreement with the government of Colombia is for 10 million doses. Under the terms of the agreements, deliveries would begin in mid-2021. Moderna’s COVID-19 vaccine is not currently approved for use in Taiwan or Colombia. The company says it will work with regulators to pursue necessary approvals prior to distribution.
Source: Moderna
Updates on COVID-19 treatments and vaccines
FDA Schedules Feb. 26 Meeting To Review J&J’s COVID-19 Vaccine
The US Food and Drug Administration (FDA) has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on February 26, 2021 to discuss the request for emergency use authorization for Johnson & Johnson’s (J&J) COVID-19 vaccine.
Last week (February 4, 2021), J&J filed for emergency use authorization to the FDA for its single-dose COVID-19 vaccine following positive results from a Phase III trial. The company has also initiated rolling submissions with several health agencies outside the US and says it will submit a conditional marketing authorization application with the European Medicines Agency in the coming weeks (as reported on February 4, 2021).
For its February 26 meeting, the FDA says it will make background material available to the public no later than two business days before the meeting. If the FDA is unable to post the background material on its website prior to the meeting, the agency says any background material will be made publicly available at the time of the advisory committee meeting and additional materials will be posted on the FDA’s website after the meeting.
J&J partners with Google’s Verily on COVID-19 study
In separate news, J&J is partnering with Verily, the life sciences arm of Alphabet, the parent company of Google, for a COVID-19 immune response study. The study aims to collect detailed information about how the coronavirus affects the immune system immediately after someone tests positive for COVID-19. The study will collect biological measurements, clinical, and epidemiological data at the time of COVID-19 testing to characterize longitudinal molecular and/or immunological signatures associated with progression of disease resulting from SARS-CoV-2, the virus that causes COVID-19, over 28 days.
Source: US Food and Drug Administration and Verily
Novavax Starts Rolling Review Process for COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has started the rolling review process for the authorization of NVX-CoV2373, its COVID-19 vaccine, with multiple regulatory agencies, including the US Food and Drug Administration, the UK’s Medicines and Healthcare products Regulatory Agency, the European Medicines Agency, and Health Canada.
The reviews will continue while the company completes its Phase III trials in the UK and US and through initial authorization for emergency use granted under country-specific regulations. As part of the rolling review, the company will continue to submit additional information, including clinical and manufacturing data.
The company says the vaccines has shown efficacy against the original strain of COVID-19 and emerging variants in the UK and South Africa.
Source: Novavax
CureVac, UK Gov’t in Pact for COVID-19 Vaccines Against Variants
CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics and vaccines, has entered a collaboration with the UK government to develop and manufacture potential vaccine candidates against COVID-19 variants.
The UK government’s Vaccines Taskforce, informed by the newly formed Variant Vaccine Expert Advisory Group, and CureVac will assess multiple SARS-CoV-2 variants and are expected to generate vaccine candidates against the variants. Clinical studies will be expedited in the UK in order to secure emergency or conditional marketing authorizations for selected vaccine candidates against the most threatening variant viruses. Any resulting vaccine candidates will be manufactured and distributed in the UK and its overseas and dependent territories, subject to regulatory approval.
CureVac will also transfer its technology to enable the manufacturing of clinical and commercial quantities of any vaccines that result from the collaboration as well as for the manufacturing of CureVac’s existing COVID-19 vaccine (CVnCoV), which is currently in Phase III clinical trials. CVnCoV is supported by Bayer, and CureVac is co-developing its COVID-19 vaccine candidates against COVID-19 variants with GlaxoSmithKline.
Subject to regulatory approval, the agreement includes an initial supply of 50 million doses of variant vaccines to the UK with some production expected to take place in the UK. Additionally, the agreement foresees that manufacturing capabilities will be in place for rapid production of large quantities of variant vaccines for the UK if and when needed over the next three years (as reported on February 5, 2021). CureVac is expecting to use its broader manufacturing network to produce variant vaccine candidates for global supply.
Source: CureVac
Sinovac Gets Conditional Marketing OK in China for COVID-19 Vaccine
Sinovac Biotech, a Beijing, China-based biopharmaceutical company, has received conditional marketing authorization for CoronaVac, its COVID-19 vaccine, in individuals aged 18 and above, by the China National Medical Products Administration (NMPA).
Sinovac began rolling submission to the NMPA in September 2020, and the NMPA carried out rolling reviews when the submission was made. As of February 4, 2021, the company made more than 40 submissions to the NMPA. After obtaining the preliminary efficacy results, Sinovac formally filed for conditional marketing authorization on February 3, 2021. The authorization is based on the results of the two-month data of the Phase III clinical trials. The final results are not yet available, and efficacy and safety results will be further confirmed.
The company started Phase III trials of CoronaVac on July 21, 2020. Trials were conducted in Brazil, Turkey, Indonesia, and Chile. The Phase III trials conducted in Brazil and Turkey evaluated the efficacy of the vaccine candidate in healthcare workers who provide treatment to COVID-19 patients. In Turkey, participants comprised healthcare workers in the first stage and the general population in the second stage. Based on an analysis of 29 cases, the efficacy rate for COVID-19 prevention was 91.25% after 14 days following the two-dose vaccination.
CoronaVac is being used under emergency use approval in Indonesia, Brazil, Turkey, and Chile.
Source: Sinovac (authorization) and Sinovac (results)
Cellitron’s COVID-19 Treatment Authorized in South Korea
Celltrion, an Incheon, South Korea-based biopharmaceutical company, reports that the Korean Ministry of Food and Drug Safety (MFDS) granted conditional marketing authorization (CMA) for the emergency use of the company’s COVD-19 drug, regdanvimab.
The CMA allows for emergency use in adult patients aged 60 years and over or with at least one underlying medical condition (cardiovascular, chronic respiratory disease, diabetes, high blood pressure) with mild symptoms of COVID-19 and adult patients with moderate symptoms of COVID-19.
Celltrion is also evaluating the drug against both the UK and South African COVID-19 variants with results expected in the coming days (as reported on February 5, 2021).
Source: Celltrion
News on COVID-19 testing
Thermo Fisher Launches COVID-19 Diagnostic Assay
Thermo Fisher Scientific has launched its CE-IVD-marked, Applied Biosystems TaqPath COVID–19 High Throughput Combo Kit for diagnosis of SARS-CoV-2, the virus that causes COVID-19.
The company says the kit enables clinical and public health laboratories to test up to 8,000 COVID-19 samples a day with fewer staffing requirements and a reliable supply of kits, reagents, and consumables.
The kit is compatible with the Amplitude platform, a molecular diagnostic system that allows labs to increase their COVID-19 testing capacity by combining Thermo Fisher’s extraction and PCR instruments with liquid-handling products from Tecan Group, a Männedorf, Switzerland-based company specializing in laboratory automation and liquid handling.
The diagnostic assay also received Interim Order Authorization from Health Canada on January 21, 2021. Thermo Fisher has secured a contract with a large provincial authority in Canada for the Amplitude systems.
Thermo Fisher says it now has capacity to produce more than 20 million tests per week and continues to work closely with laboratories, governments, academic institutions and other stakeholders to ensure each has a supply of tests and materials.
Source: Thermo Fisher Scientific
