Pharma COVID Roundup: News from J&J, Pfizer, Moderna, AstraZeneca
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from J&J, Pfizer, Moderna, AstraZeneca, GSK, Lilly, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
J&J Issues Statement on COVID-19 Vaccine Mfg Issue in US
Johnson & Johnson (J&J) issued a statement regarding a manufacturing issue of its COVID-19 vaccine at Emergent BioSolutions’ facility in Baltimore, Maryland.
“This quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine,” the company said in a March 31, 2021 statement, “This batch was never advanced to the filling and finishing stages of our manufacturing process. This is an example of the rigorous quality control applied to each batch of drug substance.”
The issue was identified and addressed with Emergent and shared with the US Food & Drug Administration (FDA).
J&J says it is continuing to work with the FDA and Emergent toward the emergency use authorization of the Emergent’s Bayview Facility in Baltimore. J&J is providing additional experts in manufacturing, technical operations, and quality to be on site at Emergent to supervise, direct, and support all manufacturing of its COVID-19 vaccine.
“In coordination with the US Department of Health & Human Services, these steps will enable us to safely deliver an additional 24 million single-shot vaccine doses through April (April 2021),” the company said in its statement. The company continues to expect to deliver its COVID-19 vaccine at a rate of more than one billion doses by the end of 2021.
J&J met its commitment to deliver enough single-shot vaccines by the end of March (March 2021) to enable the full vaccination of more than 20 million people in the US. This is part of the company’s plan to deliver 100 million single-shot vaccines to the US during the first half of 2021 with the aim to deliver those doses by the end of May (May 2021).
Source: Johnson & Johnson
J&J, Africa in Supply Pact for COVID-19 Vaccine
Johnson & Johnson (J&J) has entered into an agreement with the African Vaccine Acquisition Trust (AVAT) to supply up to 220 million doses of its single-shot COVID-19 vaccine candidate to the African Union’s (AU) 55 member states with delivery beginning in the third quarter of 2021.
Additionally, AVAT has the potential to order an additional 180 million doses, for a combined total of up to 400 million doses through 2022. The availability of the vaccine is subject to its successful approval or authorization by the national regulatory authorities of AU member states.
In December 2020, J&J entered into an agreement in principle with Gavi, a global public health partnership, in support of the COVAX Facility, a global initiative for equitable access to COVID-19 vaccines. J&J and Gavi expect to enter into an advance purchase agreement that would provide up to 500 million doses of the company’s COVID-19 vaccine to COVAX through 2022.
J&J has established a global manufacturing and supply network for its COVID-19 vaccine, collaborating with nine partners across four continents, including Aspen Pharmacare, a Durban, South Africa-based pharmaceutical company. Aspen will support vaccine shipments to the AU member states and will also contribute to global availability of the vaccine.
Source: Johnson & Johnson
Moderna Ships 100-Millionth Dose of COVID-19 Vaccine to the US
Moderna, a biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has shipped the 100-millionth dose of its COVID-19 vaccine to the US government.
Moderna says it has increased its shipments to the US government five-fold since receiving emergency use authorization from the US Food and Drug Administration on December 18, 2020, from more than 16 million doses in the fourth quarter of 2020 to 88 million doses to date (as reported on March 29, 2021) for the first quarter of 2021.
More than 67 million doses of Moderna’s COVID-19 vaccine have been administered in the US, according to the US Centers for Disease Control and Prevention.
Monthly shipments to the US government in the first quarter were 18 million doses in January (January 2021), 26 million doses in February (February 2021), and 44 million doses to date in March (March 2021). Looking forward, the company expects to ship 40 million to 50 million doses per month to the US government to fulfill its commitments. All US government supply comes from Moderna’s dedicated supply chain in the US.
The company expects to meet its commitment dates to the US government for all currently ordered doses of the COVID-19 vaccine, including delivery of the second 100 million doses by the end of May 2021 and the third 100 million doses by the end of July 2021.
Source: Moderna
COVAX Provides Update on Delay for AstraZeneca COVID-19 Vaccine
The COVAX Facility has notified participating economies that deliveries of doses of AstraZeneca’s COVID-19 vaccine from the Serum Institute of India (SII) will be delayed in March (March 2021) and April (April 2021) due to the increased demand for COVID-19 vaccines in India. COVAX and the Indian government remain in discussions to ensure some supplies are completed.
According to the agreement between Gavi and SII, which included funding to support an increase in manufacturing capacity, SII is contracted to provide COVAX with the AstraZeneca-Oxford COVID-19 vaccine to 64 lower-income economies participating in the Gavi COVAX AMC, a mechanism within the COVAX Facility, alongside its commitments to the Indian government.
To date (as reported on March 25, 2021), COVAX has been supplied with 28 million doses of AstraZeneca’s COVID-19 vaccine and was expecting an additional 40 million doses to be available in March (March 2021) and up to 50 million doses in April (April 2021). COVAX has notified all affected economies of potential delays. SII has pledged that, alongside supplying India, it will prioritize the COVAX multilateral solution for equitable distribution.
Separately, the COVAX Facility has informed participants allocated AstraZeneca-manufactured doses of the COVID-19 vaccine that some of the first deliveries due in March (March 2021) are now set to take place in April (April 2021). AstraZeneca is working to enable initial supply to 82 countries through COVAX in the coming weeks (as reported on March 25, 2021).
Source: World Health Organization
Updates on COVID-19 treatments and vaccines
Pfizer, BioNTech Confirm High Efficacy of COVID-19 Vaccine
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, report new results that show that the companies’ COVID-19 vaccine is highly effective with 91.3% vaccine efficacy, measured seven days through up to six months after the second dose of the two-dose vaccine.
In the analysis of 927 confirmed symptomatic cases of COVID-19 observed in a Phase III study, the vaccine was 100% effective in preventing severe disease as defined by the US Centers for Disease Control and Prevention and 95.3% effective in preventing severe disease as defined by the US Food and Drug Administration (FDA).
The vaccine was also 100% effective in preventing COVID-19 cases in South Africa, where the B.1.351 lineage is prevalent.
Separately, the companies reported the vaccine demonstrated 100% efficacy and antibody responses in a Phase III trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection. The results reported exceeded those recorded earlier in vaccinated participants aged 16 to 25 years old.
The companies plan to submit these data to the FDA and the European Medicines Agency for a requested amendment to the emergency use authorization of the vaccine in the US and the EU conditional marketing authorization to expand use in adolescents 12-15 years of age.
Last week (as reported on March 31, 2021), Pfizer and BioNTech dosed the first healthy children in a global Phase I/II/III study to further evaluate the safety, tolerability, and immunogenicity of Pfizer’s/BioNTech’sCOVID-19 vaccine in children 6 months to 11 years of age.
Source: Pfizer (second dose), Pfizer (adolescents), BioNTech (second dose), and BioNTech (adolescents)
GSK, Vir Biotechnology Submit EUA Request for COVID-19 Treatment
GlaxoSmithKline (GSK) and Vir Biotechnology, a San Francisco-based clinical-stage biopharmaceutical company, have submitted an application to the US Food and Drug Administration (FDA) requesting emergency use authorization (EUA) for VIR-7831, an investigational dual-action SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents with mild-to-moderate COVID-19 who are at risk for progression to hospitalization or death.
GSK and Vir will continue discussions with the European Medicines Agency and other global regulators to make VIR-7831 available to patients with COVID-19 as soon as possible.
Additionally, GSK, Vir, and Eli Lilly and Company have reported that bamlanivimab, Lilly’s neutralizing antibody against COVID-19, in combination with VIR-7831 demonstrated a 70% relative reduction in persistently high viral load in a Phase II trial studying low-risk adult patients with mild to moderate COVID-19.
Source: GlaxoSmithKline (EUA), GlaxoSmithKline (Phase III data), Vir Biotechnology (EUA), Vir Biotechnology (Phase III data), and Eli Lilly and Company
News on COVID-19 testing
Fuifilm Launches SARS-CoV-2 Mutation Detection Kits, Antigen Diagnostic Test
Fujifilm has announced the launch of SARS-CoV-2 mutation detection kits and the launch of a SARS-CoV-2 antigen rapid diagnostic test.
Fujifilm Wako Pure Chemical Corporation has launched the N501Y mutation detection kit and E484K mutation detection kit to detect SARS-CoV-2 variants. The genetic testing kits use a DNA amplification response to detect SARS-CoV-2 mutations. The N501Y mutation detection kit and the E484K mutation detection kit can be used on the RNA extracted from SARS-CoV-2 positive specimens to determine whether the virus is the original type, UK variant, South African variant, or Brazilian variant.
Separately, Fujifilm has also launched the Fujifilm COVID-19 Ag Test, an antigen test kit for detecting SARS-CoV-2, which will be released in Europe in early April 2021. The kit, to be sold as in-vitro diagnostic medical device, was developed with the use of highly-sensitive detection technology based on silver halide amplification used in the photo-developing process.
Source: Fujifilm (mutation detection kits) and Fujifilm (antigen diagnostic test)
