Coronavirus Breaking News

The U.S. FDA posted online background material for the upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) public meeting, scheduled for Thursday, December 10, 2020.

This VRBPAC digital meeting will discuss Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) for the prevention of COVID-19 in individuals 16 years of age and older.

Following this meeting, the U.S. CDC's vaccine committee has scheduled an emergency review of the FDA's recommendations on December 11th and 13th, then vote on their recommendation.

BioNTech SE and Pfizer Canada announced that Health Canada has granted Authorization under an Interim Order for the emergency use of their mRNA COVID-19 vaccine (BNT162b2). BioNTech will hold the regulatory approval in Canada, while Pfizer Canada will have the commercialization rights.

Cole Pinnow, President, Pfizer Canada, stated in a press release issued on December 9, 2020: “We commend Health Canada for its careful and thorough assessment of our COVID-19 vaccine and timely action to help protect Canadians.”

Earlier on December 9th, the UK's National Health Service (NHS) medical director Stephen Powis reported: 'the advice had been changed after two NHS workers reported anaphylactoid reactions associated with receiving the vaccine. As is common with new vaccines the MHRA (regulator) have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination.'

Despite early reports suggesting a decline in preterm births during the COVID-19 pandemic, an analysis published by the JAMA on December 7, 2020, by researchers at Children's Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania, has found no change in preterm births or stillbirths at Philadelphia hospitals in the first 4-months of the 2020 pandemic.

Moderna, Inc. announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 million to 7.5 million doses of the experimental mRNA-1273 vaccine candidate.

“We appreciate the continued confidence and support shown by the Swiss Federal Government as they increase their supply agreement with us,” said Stephane Bancel, Moderna’s CEO, in a press release issued on December 8, 2020. “We are building Moderna’s first commercial organization outside of North America in Basel in support of the global response to this pandemic.”

The first full results from interim analysis confirm that the Oxford COVID-19 vaccine (AZD1222) has an acceptable safety profile and is efficacious against symptomatic COVID-19 disease, with no hospitalizations or severe disease reported in the COVID-19 vaccine group so far, reported The Lancet on December 8, 2020.

Study lead author Professor Andrew Pollard, University of Oxford, UK, said in a press release: "Control of the pandemic will only be achieved if the licensing, manufacturing and distribution of these vaccines can be achieved at an unprecedented scale and vaccination is rolled out to those who are vulnerable."

"Our findings indicate that our vaccine's efficacy exceeds the thresholds set by health authorities and may have a potential public health impact."

A large-scale study assessed SARS-CoV-2 infections in 919 animals living in northern Italy, at a time of frequent human infection. No animals tested PCR positive in this study published in the journal Nature on December 4, 2020.

However, 3.3% of dogs and 5.8% of cats had measurable SARS-CoV-2 neutralizing antibody titers, with dogs from COVID-19 positive households being significantly more likely to test positive than those from COVID-19 negative households.

'Based on current knowledge, it is unlikely that infected pets play an active role in SARS-CoV-2 transmission to humans. However, the animal-to-human transmission may be more likely under certain environmental conditions, such as the high animal population densities encountered on infected mink farms,' added these researchers.

The journal Clinical Infectious Diseases reported on December 3, 2020, that while younger adults (18 - 49 years) with no underlying health conditions have been considered safer from COVID-19's severe outcomes, of those who were eventually hospitalized for the new disease, 22% were admitted to intensive care units, 10% needed mechanical ventilation.

However, of the 513 patients in this study based on CDC data, only 0.6% (3 patients) died.