COVID News: Lilly, Moderna, Novavax & MoreBy
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Moderna, Rovi, Novavax, Takeda, Regeneron, AstraZeneca, CureVac, GSK, Sinovac, Lilly, and the US Food and Drug Administration.
Manufacturing and supply of COVID-19 vaccines and drugs
Moderna, Rovi Recall One Lot of Moderna’s COVID-19 Vaccine
Moderna and Rovi Pharma Industrial Services, a Madrid, Spain-based CDMO, are recalling one lot of Moderna’s COVID-19 vaccine, Spikevax, due to a foreign body being found in one vial. The impacted vial was punctured and was not administered. Rovi is providing contract manufacturing of the vaccine.
The companies were alerted to this issue through a product complaint from a vaccination center in Malaga, Spain. The vial was returned for forensic assessment and investigation. This lot, which consisted of 764,900 doses, was distributed in Norway, Poland, Portugal, Spain, and Sweden from January 13-14, 2022.
Moderna conducted a cumulative search of its global safety database and reported that no safety or efficacy issues have been identified to date (as reported on April 8, 2022),
Updates on COVID-19 treatments and vaccines
Moderna Provides Update on COVID-19 Vaccine Boosters
Moderna reports new clinical data on its bivalent COVID-19 booster platform, including for its first bivalent booster candidate, mRNA-1273.211.
The company reported that a 50-µg booster dose of mRNA-1273.211 demonstrated activity against Beta, Delta and Omicron variants of concern one month after administration and which continued six months after administration for the Beta and Omicron variants as well. A 50-µg booster dose of mRNA-1273.211 was generally well tolerated with a reactogenicity profile comparable to a booster dose of mRNA-1273 (Moderna’s primary COVID-vaccine) at the 50-µg dose level.
The results indicate that the bivalent booster vaccine candidate, mRNA-1273.211, at the 50-µg dose level induced higher antibody responses than Moderna’s 50-µg mRNA-1273 booster, even when the variants were not included in the booster vaccine.
Moderna is developing updated booster candidates to address the continued evolution of the SARS-CoV-2 virus, including monovalent and bivalent candidates targeting multiple variants of concern. This includes multiple bivalent booster candidates: mRNA-1273.211 (9 spike protein mutations, based on the Beta variant), mRNA-1273.214 (32 spike protein mutations, based on the Omicron variant) as well as mRNA-1273.211, which includes four mutations and mRNA-1273.214, which includes 32 mutations present in the Omicron variant
Moderna’s bivalent prototype and Omicron booster vaccine candidate (mRNA-1273.214) is currently in a Phase II/III study. The company expects initial data on mRNA-1273.214 in the second quarter of this year (2022).
Novavax Gets OK for COVID-19 Vaccine in Japan, Thailand, Switzerland
Novavax, a Gaithersburg, Maryland-based vaccine company, and its partner in Japan, Takeda, have received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare for Novavax’s COVID-19 vaccine, Nuvaxovid, for primary and booster immunization in individuals aged 18 and older.
Novavax licensed and transferred its manufacturing technologies and is supplying its Matrix-M adjuvant to enable Takeda to manufacture the vaccine at Takeda’s facility in Hikari, Japan. Takeda, the marketing authorization holder for Nuvaxovid in Japan, says it will begin distribution of doses purchased by the Japanese government as soon as possible (as reported on April 18, 2022).
Separately, the Thailand Food and Drug Administration has granted emergency use authorization for Novavax’s COVID-19 vaccine in individuals 18 years of age and older. The vaccine is manufactured and marketed by the Serum Institute of India, a Pune, India-based vaccine manufacturer, under the brand name Covovax.
Additionally, Swissmedic, the Swiss Agency for Therapeutic Products, has granted Novavax conditional marketing authorization for the vaccine in individuals 18 years of age and older. Novavax previously announced an agreement with the government of Switzerland to supply up to six million doses of its COVID-19 vaccine.
FDA Extends Review of Regeneron’s COVID-19 Antibody Cocktail
The US Food and Drug Administration (FDA) has extended by three months its review of the biologics license application (BLA) for Regeneron Pharmaceuticals’ antibody cocktail for treating COVID-19, REGEN-COV (casirivimab and imdevimab), for treat COVID-19 in non-hospitalized patients and as a prophylaxis in certain individuals.
The extension is due to ongoing discussions with the FDA on pre-exposure prophylactic use, for which Regeneron has submitted additional data from its completed prophylaxis trial that the FDA has accepted for review. The FDA considers the submission of these additional data to be a major amendment to the BLA and has provided a new target action date of July 13, 2022. The FDA has not requested any new studies to complete its review of the current BLA at this time.
REGEN-COV, an investigational monoclonal antibody therapy, first became available in the US in November 2020, via emergency use authorization (EUA) by the FDA. In January 2022, FDA amended the EUA to exclude its use in geographic regions where infection or exposure is likely due to a variant that is not susceptible to the treatment. Therefore, REGEN-COV is not currently authorized for use in any US state, territory or jurisdiction.
AstraZeneca Reports Phase III Results for COVID-19 Drug
AstraZeneca reported results for its a long-acting antibody combination, Evusheld (tixagevimab co-packaged with cilgavimab), for treating COVID-19. The company reported that Evusheld reduced the risk of developing symptomatic COVID-19 by 77% in a primary analysis and by 83% in a six-month follow-up analysis in a Phase III trial in high-risk populations.
Additional pharmacokinetic data showed that Evusheld concentrations remained elevated in serum for six months after administration, which the company says supports that a single-dose could provide long-term protection against COVID-19 lasting at least six months.
CureVac Reports Preclinical Data for mRNA COVID-19 Vaccine
CureVac, a Tubingen, Germany-based biopharmaceutical company developing mRNA therapeutics and vaccines, reported preclinical data for its bivalent second-generation COVID-19 vaccine candidate. CureVac is jointly developing the vaccine with GlaxoSmithKline (GSK).
The vaccine candidate combines two mRNAs encoding for the Beta and the Delta variants. The company reported strong protection and immune responses during preclinical challenge study and demonstrated neutralizing capacity against the Omicron variant in vaccinated animals.
Hong Kong OKs Sinovac’s Omicron-Specific COVID-19 Vaccine for Clinical Trial
Sinovac Biotech, a Beijing, China-based bio/pharmaceutical company, reports that its COVID-19 vaccine candidate for the Omicron variant has been approved for a clinical trial in Hong Kong.
US Gov’t To Extend Shelf Life of Lilly’s COVID-19 Antibody Cocktail
The US Food and Drug Administration (FDA) and the US Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) issued a statement that the shelf-life of Eli Lilly and Company’s COVID-19 antibody cocktail, bamlanivimab and/or etesevimab, is being evaluated, and an update regarding shelf-life extension is planned for early May 2022.
In the interim, all bamlanivimab and etesevimab vials may be retained until the shelf-life extension evaluation is complete and posted, regardless of the current labeled expiry date or previously provided extension dates. This recommendation applies to all unopened vials of bamlanivimab and etesevimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization.
News on COVID-19 testing
FDA OKs COVID-19 Diagnostic Test Using Breath Samples
The US Food and Drug Administration (FDA) has issued emergency use authorization for a COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection from InspectIR Systems, a Frisco, Texas-based research, development, and device company.
The InspectIR COVID-19 Breathalyzer uses gas chromatography–mass-spectrometry (GC-MS) to separate and identify chemical mixtures and detect five volatile organic compounds (VOCs) associated with SARS-CoV-2 infection in exhaled breath. When the InspectIR COVID-19 Breathalyzer detects the presence of VOC markers of SARS-CoV-2, a presumptive (unconfirmed) positive test result is returned and should be confirmed with a molecular test.
InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day. At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.
Source: US Food and Drug Administration