COVID News: Moderna, Pfizer, AstraZeneca, NIH & moreBy
The latest on COVID-19 vaccines/drugs and manufacturing from Moderna, Pfizer, BioNTech, AstraZeneca, Novavax, the US Department of Health and Human Services, and the US National Institutes of Health. Highlights below.
Manufacturing and supply of COVID-19 vaccines and drugs
* US Gov’t, Industry Meet To Discuss Transition of COVID-19 Vaccines, Drugs To Commercial Marketplace
* Moderna, Canada in Pact for Bivalent Omicron COVID-19 Vaccine Booster
Updates on COVID-19 Vaccines and Therapeutics
* Moderna Files Patent Lawsuits Against Pfizer/BioNTech Over COVID-19 Vaccine
* Dr. Anthony Fauci To Step Down from NIH’s NIAID and as President’s Chief Medical Advisor
* Moderna Receives FDA Authorization for COVID-19 Vaccine Bivalent Omicron Booster
* Pfizer, BioNTech Receive FDA Authorization for COVID-19 Vaccine Bivalent Omicron Booster
* FDA, CDC OK Novavax’s COVID-19 Vaccine in Adolescents
* AstraZeneca Gets Approval for COVID-19 Drug in Japan
Manufacturing and supply of COVID-19 vaccines and drugs
US Gov’t, Industry Meet To Discuss Transition of COVID-19 Vaccines, Drugs To Commercial Marketplace
The US Department of Health and Human Services (HHS) convened a meeting late last month (August 2022) of more than 100 representatives from state and local government, healthcare providers and insurers, bio/pharmaceutical companies and vaccine manufacturers, patient advocates, and other groups, to discuss the transition of the procurement and distribution of COVID-19 vaccines and therapeutics from a federally managed system by the US government to the commercial marketplace. As early as January 2023, the US government anticipates no longer having federal funds to purchase or distribute vaccines and will need to transition these activities to the commercial market, similar to seasonal flu or other commercially available vaccines.
In an August 30, 2022, blog post, Dawn O’Connell, Assistant Secretary for Preparedness and Response of the HHS said that such a transition had always been planned, but the transition has been accelerated due a lack of additional funding by Congress to support further distribution and procurement by the US government.
“We have always intended to transition this work to the commercial market and have been planning for that transition for some time now,” said O’Connell in her post. “Unfortunately, the timeline to make the transition has accelerated over the past six months without additional funds from Congress to support this work. We have been grateful for the bipartisan Congressional support of our response efforts, but it has been more than 530 days since we last received new funding for COVID-19 and without additional funds, it will be difficult to continue procuring and distributing these countermeasures.”
In terms of commercialization planning, she said that additional funding would allow for an orderly wind-down of the federal government’s procurement and distribution while the commercial market ramps up and would also allow the US government to more effectively ensure equitable distribution and coverage for the underinsured and uninsured. She said that the US government is continue to move forward with detailed commercialization planning, with its recently convened meeting as a step in that process.
Earlier this month (August 2022), bebtelovimab, a monoclonal antibody treatment for COVID-19, was transitioned to the commercial marketplace. Based on current projections, the HHS expects to run out of its remaining federal supply of the preventative treatment, Evusheld (tixagevimab co-packaged with cilgavimab), as soon as early 2023, followed by the oral antiviral, Lagevrio (molnupiravir) sometime in the first or second quarter of next year (2023), and Paxlovid (nirmatrelvir tablets; ritonavir tablets) in mid-2023. As the federal supply of the treatments runs out, it expects to transition these products to the commercial market.
Moderna, Canada in Pact for Bivalent Omicron COVID Booster
The government of Canada has exercised its option to purchase an additional 4.5 million doses of Moderna’s Omicron-containing bivalent vaccine booster candidate, in addition to moving forward its scheduled delivery of 1.5 million doses of the bivalent vaccine candidate from 2023 to 2022.
Moderna and the government of Canada have also agreed to convert an order of six million doses of the company’s primary COVID-19 vaccine, Spikevax, to an Omicron-containing bivalent vaccine. The agreement is subject to regulatory approval of the Omicron-containing bivalent vaccine booster candidate by Health Canada, with doses scheduled for delivery in 2022.
Updates on COVID-19 Vaccines and Therapeutics
Moderna Files Patent Lawsuits Against Pfizer’s/BioNTech’s COVID-19 Vaccine
Moderna is filing patent infringement lawsuits against Pfizer and BioNTech, asserting that Pfizer and BioNTech infringed Moderna patents Moderna filed between 2010 and 2016 covering Moderna’s foundational mRNA technology when developing the companies’ COVID-19 vaccine. The lawsuits are being filed in the United States District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany.
Moderna is asserting the technology used by the companies in developing their mRNA COVID-19 vaccine infringed on two Moderna patents for mRNA technology. First, Moderna claims that Pfizer and BioNTech decided to proceed with a vaccine that has the same exact mRNA chemical modification to Moderna’s COVID-19 vaccine, Spikevax. Moderna says that scientists began developing this chemical modification that avoids provoking an undesirable immune response when mRNA is introduced into the body in 2010 and were the first to validate it in human trials in 2015.
Second, Moderna claims that Pfizer and BioNTech copied Moderna’s approach to encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus. Moderna says that its scientists developed this approach when they created a vaccine for the coronavirus that causes Middle East respiratory syndrome years before COVID-19 first emerged.
None of the patent rights which Moderna is seeking to enforce relate to any intellectual property generated during Moderna’s collaboration with the US National Institutes of Health to combat COVID-19. The company says that collaboration began only after the patented technologies at issue were proven successful in clinical trials in 2015 and 2016.
Moderna is seeking compensation for the patent infringement, but is not seeking that Pfizer/BioNTech remove their COVID-19 vaccine from the market or is not asking for an injunction to prevent its future sale. In addition, Moderna is not seeking damages related to Pfizer’s sales to 92 low-and middle-income countries and is not seeking damages for Pfizer’s sales where the US government would be responsible for any damages. Moderna is also not seeking damages for activities occurring before March 8, 2022.
BioNTech stated that its work is original, and that it will defend against all allegations of patent infringement. Pfizer did not issue a release as of September 1, 2022.
Dr. Anthony Fauci To Step Down as Director of NIH’s NIAID and as the President’s Chief Medical Advisor
Dr. Anthony Fauci, Chief Medical Advisor to President Joe Biden and Director of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) has he will be stepping down from the positions of Director of the NIAID and Chief of the NIAID Laboratory of Immunoregulation, as well as Chief Medical Advisor to President Joe Biden, effective in December (December 2022).
Dr. Fauci has played a central role in the management of the COVID-19 pandemic for the US government. Over the past 38 years as NIAID Director, he served under and advised seven US Presidents, beginning with President Ronald Reagan, on newly emerging and re-emerging infectious disease threats, including HIV/AIDS, West Nile virus, the anthrax attacks, pandemic influenza, various bird influenza threats, Ebola and Zika, among others, and most recently the COVID-19 pandemic.
After more than 50 years of government service, he says he plans to pursue the next phase of his career. He wants to use what he learned as NIAID Director to continue to advance science and public health and to inspire and mentor the next generation of scientific leaders as they help prepare the world to face future infectious disease threats.
Source: National Institutes of Health
Moderna Receives FDA Authorization for Bivalent Omicron Booster
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Moderna’s BA.4/.5 Omicron-targeting bivalent COVID-19 vaccine booster, mRNA-1273.222, to adults over 18 years of age who have received either a primary series or an initial booster of any of the authorized or approved COVID-19 vaccines. The authorization was for a 50-µg booster dose of mRNA-1273.222, which includes 25 µg of mRNA encoding for the spike protein of BA.4/.5 and 25 µg encoding for the original strain of the SARS-CoV-2 virus.
The booster is expected to be available at vaccination sites nationwide in the coming days (as reported on September 1, 2022). Doses of the vaccine have been purchased by the US government’s Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological Nuclear Defense and the Army Contracting Command.
Additionally, Moderna received temporary authorization from Swissmedic, the pharmaceutical regulatory agency of Switzerland, for its Omicron-targeting bivalent COVID-19 vaccine, Spikevax Bivalent Original/Omicron (mRNA-1273.214) in individuals aged 18 years and older. Spikevax Bivalent Original/Omicron is a bivalent vaccine that contains 25 µg of mRNA-1273 (Spikevax), the company’s initial COVID-19 vaccine and 25 µg of a vaccine candidate targeting an Omicron variant of concern (BA.1). Moderna is working with Swissmedic and the government of Switzerland the Omicron-targeting bivalent vaccine to supply the product in early September. In addition, Moderna received provisional approval from the Therapeutic Goods Administration in Australia for the mRNA-1273.214 booster in individuals 18 years of age and older.
Separately, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of the mRNA-1273.214 booster in individuals 12 years of age and older, who have previously received at least a primary vaccination course against COVID-19. Following the CHMP’s positive opinion, the European Commission will make an authorization decision on the use of the vaccine as a booster dose for active immunization to prevent COVID-19. The recommendation follows a recent agreement between Moderna and the European Commission to convert contractually agreed doses of Moderna’s COVID-19 vaccine (Spikevax, mRNA-1273) to the company’s Omicron-targeting bivalent vaccines for supply in 2022, pending regulatory approval. In addition, the European Commission agreed to purchase an additional 15 million doses of Omicron-targeting vaccine booster candidates from Moderna.
Pfizer, BioNTech Receive FDA Authorization for Bivalent Omicron Booster
The US Food and Drug Administration (FDA) has granted emergency ese authorization (EUA) of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent and Omicron BA.4/BA.5, for individuals ages 12 years and older.
An application for an Omicron-adapted bivalent vaccine for children 5 through 11 years of age is planned for submission to the FDA in early October (October 2022). The companies are working with the FDA to prepare an application for an Omicron-adapted bivalent vaccine in children 6 months through 4 years of age.
Pfizer and BioNTech have also completed a submission to the European Medicines Agency (EMA) for a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster for individuals 12 years of age and older.
The Omicron BA.4 and BA.5 subvariants together are the prevalent variants of concern in the US, prompting the FDA to instruct manufacturers to develop a variant-adapted vaccine that also addresses the spike protein of the Omicron BA.4/BA.5 subvariants, according to the companies. Pfizer and BioNTech’s bivalent vaccine contains 15-µg of mRNA encoding the wild-type spike protein of SARS-CoV-2, which is present in the original Pfizer-BioNTech COVID-19 vaccine, and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants. Because the Omicron BA.4 and BA.5 subvariants contain identical spike protein amino acid sequences, both can be targeted at once with a single mRNA strand. Apart from the addition of the mRNA sequence of the Omicron BA.4/BA.5 spike protein, all other components of the vaccine remain unchanged.
As a result of this authorization, Pfizer and BioNTech will file a new supplemental biologics application (sBLA) for the Omicron BA.4/BA.5 bivalent booster vaccine and therefore withdraw the sBLA for a booster dose of the original Pfizer-BioNTech COVID-19 monovalent vaccine for individuals 16 and older. The original Pfizer-BioNTech COVID-19 vaccine will remain available as a booster for those 5 through 11 years of age and as a primary series for those 6 months of age and older.
Separately, Pfizer and BioNTech have submitted data on their Omicron-adapted bivalent vaccines to the European Medicines Agency (EMA) and other regulatory authorities globally.
The application for a variation of the conditional marketing authorization to the EMA for a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and olde follows guidance from the EMA and the International Coalition of Medicines Regulatory Authorities to work toward introducing Omicron-adapted bivalent vaccines. Pfizer and BioNTech also filed an application with the EMA for the Omicron BA.1-adapted bivalent COVID-19 vaccine booster in July (July 2022), which is currently under review by the EMA (as reported on August 26, 2022).
Both the Omicron BA.1-adapted and Omicron BA.4/BA.5-adapted bivalent boosters will be available to ship shortly after respective regulatory authorizations and will be available for use as early as September (September 2022), pending regulatory approval.
FDA, CDC OK Novavax’s COVID-19 Vaccine in Adolescents
The US Food and Drug Administration (FDA) has granted emergency use authorization for Novavax’s COVID-19 vaccine, adjuvanted, in adolescents aged 12 through 17. Following the authorization, the US Centers for Disease Control and Prevention (CDC) recommended expanding the use of the vaccine as a two-dose primary series for active immunization to prevent COVID-19 in adolescents aged 12 through 17. The CDC previously recommended use of the vaccine in adults aged 18 and older. Doses of the vaccine are available in the US.
AstraZeneca Gets Approval for COVID-19 Drug in Japan
Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted AstraZeneca’s COVID-19 drug, Evusheld (tixagevimab and cilgavimab), Special Approval for Emergency for adults and adolescents (12 years of age and older weighing at least 40 kg). The decision marks the first global marketing approval for Evusheld as a treatment for COVID-19.
Evusheld is approved for use in those whom COVID-19 vaccination is not recommended and who may have an inadequate response to a COVID-19 vaccine due to immunodeficiencies. Recipients of Evusheld for prevention should not be currently infected with or have had recent known exposure to a person infected with COVID-19.
In treatment, Evusheld is approved for adults and adolescents (12 years of age and older weighing at least 40kg) with risk factors for severe COVID-19 infection who do not require supplemental oxygen.