Vaccines

With a $5 million grant from DARPA, DNA Script and Moderna will develop a prototype for rapid mobile manufacturing of vaccines and therapeutics as part of the DARPA’s Nucleic Acids On-Demand World-Wide program.

Sanofi will perform the fill/finish of up to 200 million doses of Moderna’s COVID-19 vaccine at its Ridgefield, NJ, facility starting in September 2021.

The decision comes from the US CDC Advisory Committee on Immunization Practices following the evaluation of data showing a rare adverse event involving blood clots in combination with low platelet counts within approximately one to two weeks following vaccination.

EMA's PRAC has concluded that there is a possible link to rare cases of blood clots with low blood platelets with Janssen’s COVID-19 vaccine.

Lipid production at Evonik’s Hanau, Germany, site was set up in eight weeks and met high-quality requirements, accelerating delivery time, which was originally set for mid-2021.

A FDA report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.

The additional doses are a result of the European Commission’s expanded advance purchase agreement, which brings the total number of doses delivered to the EU to 600 million.

CDC and FDA are reviewing data from reported cases of a rare type of blood clot in people that received the Johnson & Johnson COVID-19 vaccine.

The first revision further clarifies the number of doses per vial for the vials that are already available, while the second revision allows for the availability of an additional multi-dose vial.

A Phase III trial evaluating the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, in adolescents 12 to 15 years of age showed 100% efficacy and positive antibody responses.

Set to be operational in 2026, the new facility will provide added antigen and filling capacity for Sanofi’s influenza vaccine, increasing its availability in Canada, the United States, and Europe.

GSK will provide filling capacity at its Barnard Castle facility in England.

Celonic will manufacture CvnCoV at its facility in Germany.

The company has entered into an agreement with the African Vaccine Acquisition Trust for the supply of 220 million doses of its single-shot COVID-19 vaccine for the African Union’s 55 member states beginning in the third quarter of 2021.

EMA has approved the manufacturing of drug product for BioNTech’s COVID-19 vaccine, BNT162b2, at BioNTech’s manufacturing site located in Marburg, Germany.

AstraZeneca has released the results of its primary analysis of the Phase III trial data evaluating its COVID-19 vaccine.

After releasing US Phase III trial data for AZD1222, more questions have been raised with AstraZeneca concerning potentially outdated information that could provide an incomplete view of efficacy.

To maintain business continuity and employee safety during the pandemic, many companies have begun tracking and maintaining records of employee health information.

Under an expanded agreement with J&J, Catalent Biologics will increase manufacturing capacity at its Anagni, Italy, site to accommodate the large-scale commercial supply of Janssen’s COVID-19 vaccine.

The companies will use capacity at IDT previously reserved for Takeda’s dengue vaccine candidate, TAK-003, to manufacture Janssen Pharmaceutical’s single-shot COVID-19 vaccine.

Lonza will provide a manufacturing suite at its facility in Houston, TX, for the clinical and commercial production of AdCOVID, Altimmune’s single-dose intranasal vaccine candidate.

WuXi will produce SARS-CoV-2 s-proteins for BioVaxys’ COVID-19 vaccine candidate, BVX-0320, and for its Covid-T immunodiagnostic program.

Currently, supporters of the plan include the governments of Germany, Norway, and Ethiopia; Wellcome and the Bill and Melinda Gates Foundation; the World Economic Forum; and WHO, Gavi, and UNICEF.

Rokote Laboratories Finland, an academic spin-out located in Finland, is working to develop a nasal spray vaccine against COVID-19 based on research from the University of Helsinki and the University of Eastern Finland.

Manufacturing of the vaccine will take place at Baxter’s fill/finish sterile manufacturing facilities located in Bloomington, IN.

The European Medicines Agency has begun a rolling review based on laboratory and clinical studies of the Sputnik V (Gam-COVID-Vac).

The European Medicines Agency and Health Canada have published clinical data used to support the authorization of Moderna’s COVID-19 vaccine.

With funding from the federal government, Merck will expand capacity to produce J&J’s COVID-19 vaccine.

In a pandemic, genetic vaccines offer several advantages over traditional approaches.

RDIF has announced that the Sputnik V vaccine for COVID-19 has been approved in Slovakia under the emergency use authorization procedure.