COVID Roundup: News from Pfizer, Moderna, J&J & More
By

The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Pfizer, Moderna, J&J, AstraZeneca, Merck & Co., Sanofi, GSK, Novavax, Gilead Sciences, Roche, Thermo Fisher Scientific, Samsung Biologics, MilliporeSigma and more.

Manufacturing and supply of COVID-19 vaccines and drugs

EU To Buy 200 M Doses of Pfizer’s/BioNTech’s COVID-19 Vaccine
The European Commission (EC) and European Union member states have exercised an option to purchase more than 200 million additional doses of Comirnaty, Pfizer’s/BioNTech’s COVID-19 vaccine. Contractual details are currently being finalized.

These 200 million doses are in addition to the 450 million doses already planned to be delivered in 2022 based on previously signed agreements. The number of doses to be delivered to EU member states by the companies in 2022 now totals more than 650 million doses.

The companies say this order would also cover potential vaccines adapted to the Omicron variant without additional costs, if a variant vaccine is determined to be needed and subsequently authorized or approved.

In May 2021, Pfizer and BioNTech agreed to supply 900 million doses to the EC in 2022 and 2023, with an option for an additional 900 million doses.

Source: Pfizer and BioNTech


FDA OKs Three Lots of AstraZeneca’s COVID-19 Vaccine
The US Food and Drug Administration (FDA) reported that it has found an additional three lots of AstraZeneca’s COVID-19 vaccine substance manufactured at the Emergent BioSolution’s facility in Baltimore, Maryland, to be acceptable for use for potential export. The AstraZeneca vaccine is not authorized for use in the US, but the FDA says that these AstraZeneca lots, or vaccine made from the lots, may now be exported for use.

Source: US Food and Drug Administration


Moderna, Gavi in Supply Pacts for COVID-19 Vaccine
Moderna has partnered with Gavi, a global vaccine alliance, to allow Gavi to purchase up to 650 million doses of its COVID-19 vaccine for delivery in 2021 and 2022.

For 2022, Moderna expects to supply up to 96.5 million doses in the first quarter of 2022 and an additional 136.5 million doses in the second quarter of 2022. Gavi retains an option to procure 233 million additional doses in 2022 under its original supply agreement with Moderna and under a new supply agreement, Gavi has options to purchase an additional 30 million doses in the second quarter of 2022 and an additional 100 million doses in the third quarter of 2022.

Moderna also amended an existing contract with Gavi to accelerate supply of 20 million doses to COVAX, a global initiative for equitable access to COVID-19 vaccines, by December 31, 2021, for a total of 54 million doses made available to COVAX in 2021. COVAX is led by Gavi, the Coalition for Epidemic Preparedness Innovations, and the World Health Organization.

Source: Moderna


Moderna in Supply Pacts for COVID-19 Booster Vaccine
Moderna has entered into separate agreements with Switzerland and South Korea for supply of its COVID-19 booster vaccine.

The federal Swiss government has exercised its option to purchase an additional seven million doses of Moderna’s booster vaccine for delivery in the second half of 2022. These doses are in addition to the initial seven million doses of the booster vaccine the government agreed to purchase for delivery in 2022. Switzerland’s order commitment now totals 27.5 million doses.

Separately, Moderna revised its supply pact with the South Korean government for 20 million doses of its COVID-19 vaccine or an updated booster vaccine candidate (if authorized). Under the agreement, Moderna expects to deliver 15 million doses in the third quarter of 2022 and 5 million doses in the fourth quarter of 2022. Last month (December 2021), the Ministry of Food and Drug Safety of Korea issued a marketing authorization for Spikevax, Moderna’s COVID-19 vaccine, manufactured by Samsung Biologics. 

Source: Moderna (Switzerland), Moderna (South Korea), and Samsung Biologics


Samsung, AstraZeneca Expand Mfg Pact for COVID-19 Antibody Combo
AstraZeneca and Samsung Biologics, a contract biologics manufacturer, have expanded their manufacturing collaboration to include AstraZeneca’s COVID-19 long-acting antibody combination (tixagevimab co-packaged with cilgavimab, AZD7442), and a cancer immunotherapy.

The total value of the manufacturing collaboration, which initially was formed in September 2020, expanded in May 2021, and updated in December 2021 to include the COVID-19 antibody combo and a cancer immunotherapy is $380 million, up from the initial $331-million agreement.

Source: Samsung Biologics


MilliporeSigma Partners to Support COVID-19 Vaccine Mfg
MilliporeSigma has signed an agreement with Innovative Biotech, a Nigerian biotechnology company, to design the manufacturing process for a vaccine-production facility in Nigeria. Innovative Biotech’s licensor, TechnoVax, an Elmsford, New York-based vaccine company, is developing a virus-like-particle based vaccine to target variants of COVID-19.

The collaboration is part of a West African pandemic readiness program, which aims to localize vaccine development in African nations. The first phase of the project with MilliporeSigma focuses on designing the fill—finish facility, incorporating MilliporeSigma’s Mobiussingle-use technology, and the second phase will focus on enabling continuous manufacturing.

Source: Merck KGaA


Novavax, SK bioscience in Mfg Pact for COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, and SK bioscience, a South Korean vaccine developer and manufacturer, have expanded their manufacturing collaboration and license agreements for Novavax’s COVID-19 vaccine.

Under the agreement, SK bioscience will reserve additional manufacturing capacity to produce vaccine antigen through 2022, with the possibility to extend the arrangement. The agreement builds on a previously announced advance purchase agreement between SK bioscience and the South Korean government to supply 40 million doses of the vaccine. SK bioscience may supply additional quantities in the Korean market in 2022. Additionally, SK bioscience has acquired non-exclusive rights to sell doses of Novavax’s vaccine to the governments of Thailand and Vietnam.

Source: Novavax


Updates on COVID-19 treatments and vaccines

FDA OKs Pfizer’s, Merck & Co.’s COVID-19 Antiviral Drugs
The US Food and Drug Administration (FDA) has granted emergency use authorization to two oral antiviral COVID-19 drugs: (1) Pfizer’s Paxlovid (nirmatrelvir and ritonavir) for treating COVID-19 in adults and pediatric patients (12 years of age and older and older weighing at least 40 kg [88 lbs]) and (2) Merck & Co.’s molnupiravir for treating mild-to-moderate COVID-19 in adults. Both companies also formed supply pacts with the US and UK governments.  

The US government has agreed to purchase an additional 10 million treatment courses of Paxlovid in addition to the 10 million treatment courses previously contracted to bring the total treatment courses to 20 million. Approximately 10 million Paxlovid treatment courses are slated to be delivered by the end of June (June 2022) and the remaining 10 million by the end of September (September 2022). Pfizer plans to file for full regulatory approval in the US in 2022.

Additionally, Pfizer has agreed to supply the UK government an additional 2.5 million treatment courses of Paxlovid, in addition to 250,000 treatment courses previously contracted, pending authorization, to bring the full amount of treatment courses to 2.75 million.

For Merck, the company has agreed to supply the US government approximately 3.1 million courses of molnupiravir. The UK government has agreed to purchase an additional 1.75 million patient courses in addition to a previous commitment of 480,000 courses to bring the UK’s total commitment to 2.23 million courses. The Japanese government has agreed to purchase 1.6 million courses of molnupiravir. The drug has been authorized for use in both the UK and Japan. Merck developed molnupiravir with Ridgeback Therapeutics, a Miami, Florida-based biopharmaceutical company.

Source: Pfizer (EUA), Pfizer (US purchase), Pfizer (UK purchase), FDA (Pfizer), Merck & Co. (US), Merck & Co. (Japan), Merck & Co. (UK), and FDA (Merck & Co.)


EC Grants Marketing OK for GSK’s/Vir’s COVID-19 Drug
The European Commission (EC) has granted marketing authorization to GlaxoSmithKline (GSK) and Vir Biotechnology, a San Francisco-based bio/pharmaceutical company, for Xevudy (sotrovimab) for treating adults and adolescents with COVID-19,

In July 2021, GSK and Vir announced a joint procurement agreement with the EC to supply up to 220,000 doses of sotrovimab. Following the grant of the marketing authorization in the EU, EU member states participating in the agreement can now order sotrovimab to support their pandemic responses.

Source: GlaxoSmithKline


FDA Updates EUA for Pfizer’s/BioNTech’s COVID-19 Vaccine
The US Food and Drug Administration (FDA) has amended the emergency use authorization (EUA) for Pfizer’s/BioNTech’s COVID-19 vaccine for the following: (1) authorize a single COVID-19 booster dose to include individuals 12 through 15 years of age; (2) shorten the time between the completion of primary vaccination of the vaccine and a booster dose to at least five months; and (3) allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age.

Last month (December 2021) the FDA expanded the EUA of a booster dose of Pfizer’s/BioNTech’s COVID-19 vaccine to include individuals 16 years of age and older. Pfizer and BioNTech continue to supply the COVID-19 vaccine, including booster doses, under their existing supply agreement with the US government, which continues through April 2022.

Source: US Food and Drug Administration, Pfizer (booster dose 12 years and older), Pfizer (booster dose 16 years and older), and BioNTech


EMA, WHO Recommend J&J COVID-19 Booster Vaccine
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and the World Health Organization’s (WHO) Strategic Advisory Group of Experts on Immunization (SAGE) have issued a positive opinion and interim recommendation, respectively, for Johnson & Johnson’s (J&J) COVID-19 vaccine as a booster shot for adults aged 18 years and above.

J&J also reported preliminary results from a Phase IIIb study conducted in South Africa when the Omicron variant was prevalent that showed that a homologous booster shot of its COVID-19 vaccine demonstrated 85% effectiveness against COVID-19-related hospitalization.

Source: Johnson & Johnson (EMA), Johnson & Johnson (WHO), and Johnson & Johnson (efficacy)


Moderna Reports Data on Booster Vaccine on Omicron Variant
Modern has reported that booster candidates of its primary COVID-19 vaccine (mRNA-1273) administered at 50-µg and 100-µg dose levels increased neutralizing antibody levels against the Omicron variant. The currently authorized 50-µg booster of mRNA-1273 increased neutralizing antibody levels against Omicron approximately 37-fold compared to pre-boost levels, and a 100-µg dose of mRNA-1273 increased neutralizing antibody levels approximately 83-fold compared to pre-boost levels.

In addition, Moderna says it expects to advance an Omicron-specific booster (mRNA-1273.529) to clinical trials in early 2022 and will evaluate, including Omicron, in its multivalent booster program.

Source: Moderna


EU, India OK Novavax’s COVID-19 Vaccine
The European Commission has granted Novavax conditional marketing authorization for its COVID-19 vaccine, Nuvaxovid, in individuals 18 years of age and older. The authorization follows the European Medicines Agency’s Committee for Medicinal Products for Human Use recommendation to authorize the vaccine in all 27 European Union member states.

Following authorization in the EU, the World Health Organization granted a second Emergency Use Listing (EUL) for the vaccine in individuals 18 years of age and older. The first EUL for the vaccine was granted to the Serum Institute of India, a Pune, India-based vaccine manufacturer, which is manufacturing and marketing the vaccine in India and licensed territories under the Covovax name. The vaccine was granted emergency use authorization in India late last month (December 2021). Nuvaxovid and Covovax are based on the same recombinant protein technology, and the EULs are based on a common preclinical, clinical and chemistry, manufacturing and controls (CMC) package.

Late last month (December 2021), Novavax said it was planning to submit a complete package for the vaccine to the US Food and Drug Administration by the end of 2021. The vaccine recently received emergency use authorization in Indonesia and the Philippines, Novavax also announced regulatory filings for its vaccine in multiple countries worldwide, including with its partners, SK bioscience and Takeda, which have submitted regulatory filings in South Korea and Japan, respectively. Novavax also has submitted a filing with regulatory authorities in the United Arab Emirates.

Source: Novavax (EMA), Novavax (EC), Novavax (WHO), Novavax (India), Novavax (Japan), and Novavax (UAE)


AstraZeneca Reports Data on COVID-19 Vaccine, Antibody Combo
AstraZeneca reports that Vaxzevria its COVID-19 vaccine, and Evusheld (tixagevimab co-packaged with cilgavimab), its long-acting antibody (LAAB) combination retained neutralizing activity against the Omicron variant.

Source: AstraZeneca (vaccine) and AstraZeneca (antibody combo)


EC Expands Indication for Gilead’s COVID-19 Drug Remdesivir
The European Commission (EC) has approved a variation to the conditional marketing authorization for Veklury (remdesivir), Gilead Sciences’ antiviral drug for treating COVID-19, to include adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19.

This decision follows the positive recommendation of the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency.

Source: Gilead Sciences


Sanofi, GSK Report Data for COVID-19 Booster Vaccine
Sanofi and GlaxoSmithKline (GSK) report positive preliminary data for a booster of their COVID-19 vaccine candidate and an update of a Phase III trial for the booster vaccine.  

The companies reported that a booster dose increased neutralizing antibodies 9- to 43-fold regardless of the primary vaccine received (AstraZeneca, Johnson & Johnson, Moderna, Pfizer/BioNTech) and for all age groups tested.

In addition, an Independent Data Safety Monitoring Board identified no safety concerns and recommended that a Phase III trial of the booster vaccine continue into early 2022 to accrue more data. Sanofi and GSK say they intend to file data on the booster vaccine with regulatory authorities following the Phase III results.

Source: Sanofi and GlaxoSmithKline


CEPI, Affinivax Partner for Vaccine Against COVID-19 Variants
The Coalition for Epidemic Preparedness Innovations (CEPI), a public–private partnership focused on vaccine development against emerging infectious diseases, and Affinivax, a Cambridge, Massachusetts-based bio/pharmaceutical company, have partnered to develop a vaccine against COVID-19 variants and potentially other betacoronaviruses.

CEPI will provide funding of up to $4.5 million to support initial development of a vaccine candidate based on Affinivax’s multiple antigen presenting system technology platform. CEPI’s investment in Affinivax will fund vaccine candidate design and selection, manufacturing process development, and preclinical testing against specific SARS-CoV-2 variants.

Source: Coalition for Epidemic Preparedness Innovations and Affinivax


Evotec Gets $8.5-M Grant for COVID-19 Therapeutic
Evotec, a Hamburg, Germany-based drug-discovery and development company, has been selected by the German Federal Ministry of Education and Research (BMBF) to receive a EUR 7.5-million ($8.5-million) grant for the development of EVT075, a potential immunomodulatory therapy against COVID 19.

Under the grant, Evotec will use clinical material manufactured within its Just–Evotec Biologics manufacturing platform. Evotec is one of three companies receiving a grant as part of a new initiative by the BMBF to support the clinical development of novel therapeutic candidates against COVID-19.

Source: Evotec


Amyris, ImmunityBio Form JV for COVID-19 Vaccine
Amyris, a synthetic biotechnology company, and ImmunityBio, a Culver City, California-based, clinical-stage immunotherapy company, have formed a joint venture for a COVID-19 vaccine.

Upon completion of successful human trials and regulatory approval, the joint venture’s goal is to start delivering the COVID-19 vaccine in 2022.  

Source: Amyris and ImmunityBio


Intravacc To Start Phase I/II Trial for Intranasal COVID-19 Vaccine
Intravacc, a Bilthoven, the Netherlands-based CDMO, has partnered with Leiden University Medical Center (LUMC), based in Leiden, the Netherlands, to develop and evaluate a new intranasal COVID-19 vaccine, Nanovac, in a Phase I/II study.

The Phase I/II clinical trial is expected to start at the end of 2022, and the first study data are expected in the first half of 2023.

Source: Intravacc


Testing

FDA Grants EUA to Roche’s At-Home COVID-19 Test
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Roche’s COVID-19 At-Home Test.

The test uses an anterior nasal swab sample that can be self-collected and self-tested. The test is able to produce results for SARS-CoV-2 and all known variants of concern, including Omicron. Starting in January (January 2022), the at-home test will be available across the US and in accordance with local guidelines and testing strategies. Roche says it has the capacity to produce tens of millions of tests per month.

Source: Roche


Thermo Fisher Updates SARS-CoV-2 Panel for Omicron Variant
Thermo Fisher Scientific has updated its Applied Biosystems TaqMan SARS-CoV-2 Mutation Panel to enable direct detection of the Omicron SARS-CoV-2 variant. The panel is designed with a customizable menu of real-PCR genotyping assays to identify known SARS-COV-2 variants in over an hour. The TaqMan SARS CoV-2 Mutation Panel is compatible with real-time PCR instruments already commonly used in laboratories globally.

Source: Thermo Fisher Scientific