The question of prices for a COVID-19 vaccine have raged in recent days. Gary Disbrow, acting director of the Biomedical Advanced Research and Development Authority (BARDA), told members of a Senate committee that vaccines developed with the help of taxpayer funding will come with an appropriate reduction in price. However, CDC Director Robert Redfield emphasized that the cold-chain distribution system for those products requires the same kind of at-risk investment that is used for vaccine development.
LONDON – Biontech SE announced positive preliminary data from the ongoing phase I/II trial of one of the four COVID-19 vaccines it is developing with Pfizer Inc., with participants in each of three dose groups mounting immune responses that were greater than seen in patients who recovered from COVID-19 infections.
CAJICA, Colombia – Aided by federal funds from the Brazilian government, the University of Sao Paulo is moving forward with developing a precision SARS-CoV-2 vaccine that is about to start preclinical trials.
The push for a vaccine for the COVID-19 pandemic may have no parallel in pharmaceutical history, and FDA commissioner Stephen Hahn vowed in a Senate hearing that the agency will rely on the agency’s traditional standards for scientific evidence in premarket reviews of those vaccines.
LONDON – Two months after the launch, the World Health Organization (WHO) has laid out the spending plans for its push to accelerate development and production of COVID-19 vaccines, therapeutics and diagnostics.
BEIJING – China this week approved both the country’s first mRNA vaccine candidate and its first recombinant protein subunit vaccine to begin clinical trials to fight COVID-19.
LONDON – Enterome SA has raised €46.3 million (US$52.6 million) in a mixture of debt and equity, enabling it to take a new type of cancer vaccine, based on microbiome-derived antigens that mimic neoantigens expressed on tumor cells, into the clinic.
Biotech companies with COVID-19 vaccine candidates are collaborating with Indonesian companies for overseas trials and to ensure wider availability when approved. Sinovac Biotech Co. Ltd., for example, is collaborating with Indonesia’s PT Bio Farma to test and manufacture its vaccine candidate there.
The Senate Health, Education, Labor and Pensions (HELP) Committee met again June 23 to discuss the federal government response to the COVID-19 pandemic, and one clear signal that emerged from the hearing is that Congress will have to provide annual funding to build a sustainable infrastructure for vaccine development and manufacture if the nation is to deal appropriately with the next pandemic.
DUBLIN – Translate Bio Inc. is the first beneficiary to gain from Sanofi SA’s massive $11.7 billion addition to its balance sheet, following its recent disposal of its holdings in long-time partner Regeneron Pharmaceuticals Inc. Lexington, Mass.-based Translate Bio is getting $300 million up front, another $125 million in equity investment and up to $1.9 billion in milestones under a major expansion of an existing agreement with Paris-based Sanofi to develop mRNA-based vaccines for infectious disease.