Infectious disease
Grand River Aseptic Manufacturing (GRAM) inked a deal with Janssen Pharmaceutical, a Johnson & Johnson company, to support the manufacturing of Janssen’s COVID-19 vaccine candidate.
One month after the government inked a $750 million contract with Abbott for its new, point-of-care COVID-19 test, President Trump said they will be soon be distributed across the country to double the number of tests being performed in the United States.
Barry Bloom, Ph.D., research professor of public health and former dean at the Harvard T.H. Chan School of Public Health, participated in an online forum titled “The Coronavirus Pandemic: Global Race for a Vaccine” held September 15.
A team of more than 60 scientists and bioethicists have signed a letter urging Pfizer to wait until late November before the company seeks FDA authorization of its COVID-19 vaccine candidate in an effort to ensure rigorous safety standards have been met.
On Face the Nation, Gottlieb said hospitalization rates in the United States for COVID-19 had been in a state of decline, but those numbers are now rising, which goes hand in hand with an increase in infection rates.
Pennsylvania-based Inovio said the regulatory agency has additional questions about the Phase II/III trial regarding the vaccine candidate itself, known as INO-4800, as well as the company’s Cellectra 2000 delivery device.
The company posted an interim analysis of its Phase I/IIa trial that showed a single dose of JNJ-78436735 induced a strong neutralizing antibody response in nearly all participants and was well-tolerated.
Even when a first vaccine is finally approved, much of the developing world currently stands to be left behind, as it was during the 2009 H1N1 pandemic.
Endo International’s subsidiary, Par Sterile Products, LLC, has agreed to provide fill-finish manufacturing services to Novavax for commercial distribution of the vaccine company’s nanoparticle COVID-19 vaccine candidate.
New York’s governor hinted he would delay distribution of a quickly approved vaccine until its safety and efficacy could be vetted by a panel of state scientists and researchers.
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