Pharma COVID Roundup: News from J&J, Pfizer, Moderna, FDA
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from J&J, Pfizer, BioNTech, Fosun, Sinovac, Sinopharm, and the FDA.
Manufacturing and supply of COVID-19 vaccines and drugs
FDA OKs Additional Batch of J&J’s COVID-19 Vaccine
The US Food and Drug Administration (FDA) has authorized, under emergency use authorization, the use of an additional batch of Johnson & Johnson’s (J&J) COVID-19 vaccine substance manufactured at Emergent BioSolutions’ facility in Baltimore, Maryland.
To date (as reported on July 13, 2021), a total of five batches of J&J drug substance that were manufactured at the Emergent facility have been authorized. Earlier this month (July 2021), the FDA approved one batch of the drug substance, and last month (June 2021), the FDA approved three batches of the drug substance. The FDA said it conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review, the FDA concluded that these batches are suitable for use.
While the FDA says it is not yet ready to include the Emergent plant in the EUA as an authorized manufacturing facility, the agency says it continues to work through issues there with J&J and Emergent BioSolutions management.
Source: US Food and Drug Administration
US Gov’t To Donate 12 M Doses of J&J’s COVID-19 Vaccine
The US government reports it will donate 12 million doses of Johnson & Johnson’s (J&J) COVID-19 vaccine through the COVAX Facility, a global initiative for equitable access to COVID-19 vaccines.
The US is sharing the doses via COVAX to multiple lower-income countries. The first shipment of 1.5 million doses arrived in Afghanistan on July 9, 2021.
In the coming weeks (as reported on July 9, 2021), it is anticipated that the US will allocate a second tranche of J&J’s COVID-19 vaccines to additional lower-income countries. Separately, the US has already donated eight million doses of J&J’s vaccine via a series of bilateral agreements with higher-income countries, including Brazil, Colombia, Mexico and South Korea.
The dose donations to COVAX were enabled by an agreement signed recently by the US government, J&J, and Gavi, a global vaccine alliance. All recipient countries were designated by the US government. J&J is working to support UNICEF and the Pan American Health Organization, which are leading the procurement process for Gavi/COVAX. J&J is providing the regulatory, supply-chain, and logistical support needed so that donated vaccines can be delivered to recipient countries.
The US government’s donations are in addition to J&J’s commitment to supply up to a combined 900 million doses of vaccine directly to COVAX and the African Union through 2022.
Source: Johnson & Johnson
Moderna, Argentina in Supply Pact for COVID-19 Vaccine
Moderna, a bio/pharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has entered into a supply agreement with the government of Argentina for 20 million doses of its COVID-19 vaccine or its updated variant booster vaccine candidate, if authorized. Delivery is to begin in the first quarter of 2022.
BioNTech, Fosun in Supply Pact in Taiwan for COVID-19 Vaccine
BioNTech, a Mainz, Germany-based immunotherapy company, and Fosun Industrial, a wholly owned subsidiary of Fosun Pharma, a Shanghai-based bio/pharmaceutical company, have reached advance procurement agreements to supply 10 million doses of BioNTech’s COVID-19 vaccine to Taiwan.
BioNTech is partnered with Pfizer for the companies’ COVID-19 vaccine globally, excluding China, where BioNTech has a collaboration with Fosun Pharma for both clinical development and commercialization.
BioNTech and Fosun have entered into agreements with the following: Taiwan Semiconductor Manufacturing (TSMC), a semiconductor foundry and manufacturer; Hon Hai Precision Industry, a company that provides electronic manufacturing services for computers, communications, and consumer electronic products., Yonglin Charity Foundation, and Zuellig Pharma, a healthcare services provider.
Fosun Industrial will sell a total of 10 million doses of the COVID-19 vaccines to Zuellig Pharma entrusted by TSMC, Hon Hai and Yonglin. These COVID-19 mRNA vaccines will be donated to the relevant agency of disease control of the Taiwan region for local vaccination.
Gavi, Sinovac, Sinopharm in Supply Pacts for COVID-19 Vaccines
Gavi, a global vaccine alliance, has signed advance purchase agreements (APAs) with Sinopharm, a Beijing, China-based company, and Sinovac, a Beijing, China-based bio/pharmaceutical company, for their COVID-19 vaccines, BBIBP-CorV and CoronaVac, respectively.
The agreements will begin to make 110 million doses immediately available (as reported on July 12, 2021) to participants of the COVAX Facility, a global initiative for equitable access to COVID-19 vaccines, with options for additional doses.
The Sinopharm APA enables the third-quarter supply of 60 million doses that will be made available from July 2021 through October 2021. In addition, Gavi has the option to purchase a further 60 million doses in the fourth quarter of 2021 and 50 million more doses in the first half of 2022, if necessary. This equates to a potential total of 170 million doses of the Sinopharm vaccine that could be made available to self-financing participants of the COVAX Facility, as well as participants supported by Gavi’s COVAX Advance Market Commitment (AMC), a financing instrument aimed at supporting the procurement of vaccines.
The Sinovac APA also enables the third-quarter supply of 50 million doses to be made available from July 2021 through October 2021. In addition, Gavi has the option to purchase a further 150 million doses in the fourth quarter of 2021 and 180 million more doses in the first half of 2022. In total, up to 380 million potential doses of the Sinovac vaccine could be available to both self-financing participants of the COVAX Facility as well as those supported by Gavi’s COVAX AMC.
The COVAX Facility portfolio, administered by Gavi, currently consists of agreements related to 11 vaccines and vaccine candidates from AstraZeneca/Oxford University, Clover, Johnson & Johnson, Moderna, Novavax, Pfizer/BioNTech, Sanofi/GlaxoSmithKline, the Serum Institute of India, Sinopharm, and Sinovac.
Updates on COVID-19 treatments and vaccines
J&J Reports Results on COVID-19 Vaccine Against Variants of Concern
Johnson & Johnson (J&J) reports interim results from a Phase I/IIa sub-study that demonstrated that both humoral (antibody) and cellular (T-cell) immune responses generated by its COVID-19 vaccine were strong and stable through eight months after immunization, the length of time evaluated to date (as reported on July 14, 2021).
The company says that findings indicate that a single dose of its COVID-19 vaccine elicited dual mechanisms of protection against COVID-19 disease, including against disease caused by the Delta variant (B.1.617.2) and other SARS-CoV-2 variants of concern, including the Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), Epsilon (B.1.429) and Kappa (B.1.617.1) variants, as well as the original SARS-CoV-2 strain (WA1/2020). These data suggest an expansion of neutralizing antibodies over eight months, along with the observations of durable T-cell responses and the suggestion of B-cell maturation.
Separately, the US Food and Drug Administration (FDA) has announced revisions to the vaccine recipient and vaccination provider fact sheets for J&J’s COVID-19 vaccine to include information pertaining to an observed increased risk of Guillain-Barré Syndrome (GBS) following vaccination. GBS is a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness, or in the most severe cases, paralysis. There was a rare and very low incidence reported: 100 preliminary reports of GBS following vaccination after approximately 12.5 million doses administered.
FDA, CDC Issue Statement on COVID-19 Vaccine Boosters; Pfizer Provides Update
The US Food and Drug Administration (FDA) and US Centers for Disease Control and Prevention (CDC) have issued a joint statement addressing the status of COVID-19 vaccine booster vaccinations.
In a July 8, 2021 statement, the agencies said that those who have been fully vaccinated do not need a booster shot at this time and that they continue to review any new data as they become available. “We are prepared for booster doses if and when the science demonstrates that they are needed,” the agencies said in the statement.
Meanwhile, Pfizer and BioNTech reported on data in an ongoing booster trial of a third dose of the companies’ vaccine (BNT162b2 vaccine). The companies reported that initial data from the study demonstrate that a booster dose given six months after the second dose has a consistent tolerability profile while eliciting high neutralization titers against the wild type and the Beta variant, which are 5 to 10 times higher than after two primary doses. The companies expect to publish more definitive data soon as well as in a peer-reviewed journal and plan to submit the data to the FDA, European Medicines Agency (EMA) and other regulatory authorities in the coming weeks (as reported on July 8, 2021).
The companies say that they believe a third dose of BNT162b2 has the potential to preserve the highest levels of protective efficacy against all currently known variants, including the Delta variant, and that the companies are developing an updated version of the Pfizer-BioNTech COVID-19 vaccine that targets the full spike protein of the Delta variant. The first batch of the mRNA for the trial has already been manufactured. The companies anticipate the clinical studies to begin in August (August 2021), subject to regulatory approvals
FDA Issues Report on Product Availability in COVID-19 Response
The US Food and Drug Administration (FDA) has taken approaches to address availability of critical medical products in response to COVID-19.
The agency reported that non-traditional manufacturers and community responders have helped address shortages and gaps in medical supplies during the COVID-19 pandemic, and yielded millions of pieces of equipment and supplies, such as masks, face shields and other 3D-printed medical devices. In September 2020, the FDA funded a study, conducted by America Makes, a manufacturing partner in additive manufacturing and 3D-printing technology, to summarize the impact of 3D printing on the overall COVID-19 response.
The FDA has issued a report on the use of additive manufacturing by non-traditional producers in support of the US COVID-19 response. The study shows successes, challenges, and key lessons learned to build on and improve future crisis response. The FDA is reviewing the report to assess gaps in the response and potential mitigations for future public health emergencies.
Source: US Food and Drug Administration
News on COVID-19 testing
FDA OKs Ortho-Clinical Diagnostics’ COVID Test
The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to Ortho-Clinical Diagnostics for its SARS-CoV-2 quantitative test.
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Test measures IgG antibodies to SARS-CoV-2, the virus that causes COVID-19, from an individual’s blood sample (serum and plasma) to aid in identifying people with an adaptive immune response to SARS-CoV-2, indicating recent or previous SARS-CoV-2 infection.
Source: US Food and Drug Administration