COVID News: Pfizer, Roche, Moderna, Novavax & More
The latest on COVID-19 vaccines/drugs, manufacturing and testing from Pfizer, Roche, Moderna, Novavax, Fujifilm Diosynth Biotechnologies, Siegfried, InflaRx and Eiger BioPharmaceuticals. Highlights below.
Manufacturing and supply of COVID-19 vaccines and drugs
* Pfizer To Supply Up To 6 M Courses of COVID Drug to Low-to-Middle-Income Countries
* Novavax, Fujifilm End COVID Vaccine Supply Pact, Settle for $185 M
* Novavax, Siegfried Extend COVID Vaccine Fill-Finish Pact
Updates on COVID-19 Vaccines and Therapeutics
* Pfizer, BioNTech Get FDA OK for Omicron Vaccine Booster in Children
* Moderna Gets FDA OK for Omicron Vaccine Booster in Children
* InflaRx Submits Emergency Use Request to FDA for COVID Drug
* Eiger BioPharma Will Not Seek FDA OK for COVID-19 Drug
Testing
* Roche Launches New COVID-19 Rapid Tests
Manufacturing and supply of COVID-19 vaccines and drugs
Pfizer To Supply Up To 6 M Courses of COVID Drug to Low-to-Middle-Income Countries
Pfizer has signed an agreement to supply up to six million treatment courses of its COVID-19 oral treatment, Paxlovid (nirmatrelvir tablets and ritonavir tablets), to Global Fund, a global initiative to combat HIV, tuberculosis, and malaria in low- and mid-income counties as part of the Global Fund’s COVID-19 Response Mechanism (C19RM).
The C19RM has been the primary channel for providing grant support to low- and middle-income countries to purchase COVID-19 tests, treatments, personal protective equipment, and elements to strengthen their health systems. Paxlovid treatment courses will be available for procurement through this mechanism, subject to local regulatory approval or authorization, by the 132 grant-eligible countries determined by Global Fund based on income classification and disease burden.
Pfizer expects supply to be available starting in 2022, pending regulatory authorization or approval and based on country demand.
The Global Fund agreement, along with an agreement signed with UNICEF for the supply of up to four million treatment courses for low- and middle-income countries earlier this year (2022) is part of Pfizer’s global strategy for equitable supply and access of Paxlovid. This includes a voluntary licensing agreement with the Medicines Patent Pool (MPP), a United Nations-backed public health organization, to enable the development and distribution of generic versions of Pfizer’s oral treatment to further expand long-term global supply and access. MPP has signed sublicense agreements with 38 manufacturers, who will supply the generic versions in 95 low- and lower-middle-income countries. Courses produced by these manufacturers are expected to be available as early as the fourth quarter of 2022.
Source: Pfizer
Novavax, Fujifilm End COVID Vaccine Supply Pact, Settle for $185 M
Novavax, a Gaithersburg, Maryland-based vaccine company, has ended its supply agreement for its COVID-19 vaccine with Fujifilm Diosynth Biotechnologies, a contract biologics manufacturer, and the companies have reached a settlement under which Novavax will pay up to $185 million to end the manufacturing pact.
Under the settlement, Novavax and Fujifilm mutually released all claims relating to the following: (1) the cancellation of batches to be manufactured by Fujifilm under the agreement; (2) Fujifilm’s facility idle time in 2022; (3) failure to complete product performance qualification testing of batches manufactured by Fujifilm by December 2021; and (4) any obligation by Fujifilm to reserve capacity or manufacture batches for the benefit of Novavax under the agreement.
Source: Novavax
Novavax, Siegfried Extend COVID Vaccine Fill—Finish Pact
Novavax, a Gaithersburg, Maryland-based vaccine company, and Siegfried, a Zofingen, Switzerland-based CDMO, have decided to extend their collaboration for the aseptic fill-finish of Novavax’s COVID-19 vaccine, Nuvaxovid, at Siegfried’s manufacturing site in Hameln, Germany. The original manufacturing and supply agreement started in 2021 with an original end term until the end of 2022; the agreement has now been extended until the end of 2023.
Siegfried’s collaboration with BioNTech, a Mainz, Germany-based bio/pharmaceutical company, which is partnered with Pfizer for a COVID-19 vaccine, will conclude at the end of 2022 in line with the original contractual terms, according to Siegfried.
Source: Siegfried
Updates on COVID-19 Vaccines and Therapeutics
Pfizer, BioNTech Get FDA OK for Omicron Vaccine Booster in Children
The US Food and Drug Administration (FDA) has granted emergency use authorization for a 10-µg booster dose of Pfizer’s and BioNTech’s Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 5 through 11 years of age.
Pending recommendation from the US Centers for Disease Control and Prevention, 10-µg doses will be shipped immediately (as reported on October 12, 2022).
Separately, the companies have completed a submission to the European Medicines Agency (EMA) for a variation of their marketing authorization to include a 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children 5 through 11 years of age.
Source: Pfizer (FDA authorization), Pfizer (EMA submission), BioNTech (FDA authorization) and BioNTech (EMA submission)
Moderna Gets FDA OK for Omicron Vaccine Booster in Children
The US Food and Drug Administration has granted emergency use authorization to Moderna’s BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine in children and adolescents 6 to 17 years of age.
The vaccine, Spikevax bivalent Original/Omicron BA.4-5, is a next-generation bivalent vaccine that contains 25 µg of Spikevax, the company’s original COVID-19 vaccine and 25 µg of a vaccine candidate targeting the Omicron variant BA.4/BA.5.
The authorizations are based on a 25-μg booster dose for children ages 6 to 11 years old and a 50-μg booster dose for adolescents 12 to 17 years old
Separately, the European Medicines Agency (EMA) has accepted Moderna’s conditional marketing authorization for a 50-µg booster dose of its Omicron-containing bivalent COVID booster candidate in adults 12 years and older.
Moderna’s Omicron-targeting bivalent boosters are authorized in the US, Australia, Canada, Europe, Japan, South Korea, Switzerland, Singapore, Taiwan, and the UK.
Source: Moderna (EMA acceptance) and Moderna (FDA authorization)
InflaRx Submits Emergency Use Request to FDA for COVID Drug
InflaRx, a Jena, Germany-based clinical-stage bio/pharmaceutical company developing anti-inflammatory therapeutics, has submitted a request for emergency use authorization to the US Food and Drug Administration for vilobelimab, its COVID-19 drug, for treating critically ill, intubated, mechanically ventilated COVID-19 patients. Additionally, InflaRx has been granted fast track designation from the FDA for vilobelimab.
Source: InflaRx
Eiger BioPharma Will Not Seek FDA OK for COVID-19 Drug
Eiger BioPharmaceuticals, a commercial-stage bio/pharmaceutical company, has announced that, following feedback from the US Food and Drug Administration, the company will not submit an emergency use authorization application of peginterferon lambda, the company’s COVID-19 drug, for the treatment of patients with mild-to-moderate COVID-19.
Source: Eiger BioPharmaceuticals
Testing
Roche Launches New COVID-19 Rapid Tests
Roche has launched a next-generation portfolio of SARS-CoV-2 rapid antigen tests for self-testing and professional use in countries accepting the CE Mark, a designation for products that are verified under European Union health and safety requirements. Distribution of the new rapid test portfolio is projected to begin in the coming weeks (as reported on October 12, 2022).
Roche’s new COVID-19 rapid testing products come in three new test configurations that feature enhanced performance through the use of an improved capture antibody and the addition of new digital data-sharing capabilities to all tests. Using nasopharyngeal and nasal swab samples, respectively, the tests deliver results in 15 minutes.
The three tests set to launch are the following: (1) SARS-CoV-2 Rapid Antigen Test 2.0 (nasopharyngeal sampling); (2) SARS-CoV-2 Rapid Antigen Test 2.0 Nasal (nasal sampling); and (3) SARS-CoV-2 Antigen Self Test Nasal (nasal sampling)
Source: Roche
