Little-known FDA advisory group holds first meeting about COVID-19 vaccines

Oct 22 2020

A normally backwater committee meeting of a Food and Drug Administration advisory group held Thursday highlighted the extreme importance of getting COVID-19 vaccines right. The meeting was unlike others held by the Vaccines and Related Biological Products Advisory Committee, a group of outside experts who advise FDA on whether or not to approve drugs, therapeutics and vaccines after they have gone through FDA's rigorous approval process.

Source: USA Today

COVID-19 vaccine development (so far) unfazed by virus mutations

Oct 22 2020

DENVER, Colorado — Like all living cells, the chemical makeup of viruses mutate. In some viruses, it happens frequently, like influenza. “The best information we have is with influenza and clearly we know we have to get a shot every year because of that and we would assume that coronavirus probably also have some level of copying errors,” said Dr. Michelle Barron, medical director of Infection Prevention and Control at University of Colorado Hospital.

Source: 9 News

Covid-19 vaccine researchers left in the dark as trials remain on hold

Oct 22 2020

In early September, 37 volunteers received their first dose of AstraZeneca's Covid-19 vaccine candidate at University Hospital at the University of Wisconsin, Madison. The drugmaker's vaccine requires two doses, given about a month apart. But just days after the trial began, it was put on hold. Six weeks later, with the trial still paused, the participants have missed the window to receive their second dose. The researchers, it now appears, will essentially have to start from scratch.

Source: NBC

Colorado is set to break the flu vaccine record this year

Oct 22 2020

Source: KDVR

Vaccine storage issues could leave 3B people without access

Oct 22 2020

GAMPELA, Burkina Faso | The chain breaks here, in a tiny medical clinic in Burkina Faso that went nearly a year without a working refrigerator. From factory to syringe, the world’s most promising coronavirus vaccine candidates need non-stop sterile refrigeration to stay potent and safe. But despite enormous strides in equipping developing countries to maintain the vaccine “cold chain,” nearly 3 billion of the world’s 7.8 billion people live where temperature-controlled storage is insufficient for an immunization campaign to bring COVID-19 under control.

Source: Sentinel Colorado

How the FDA plans to build physician trust for COVID-19 vaccine

Oct 19 2020

Andis Robeznieks Senior News Writer The Food and Drug Administration (FDA) is working at top speed to vet several vaccine candidates to help protect patients from SARS-CoV-2, the novel coronavirus that causes COVID-19. The agency is also fighting to regain the public’s trust in vaccines and to assure patients and physicians that science is driving the vaccine-approval process.

Source: AMA

Q&A: Peter Salk on the Lessons Learned from Vaccine Development History

Oct 16 2020

Peter Salk was 11 years old when a University of Pittsburgh team led by his father, the late Jonas Salk, created the inactivated poliovirus vaccine. The day of the 1955 announcement that the vaccine was safe, effective and potent, “everything just went crazy,” he recalls. “There were so many calls from reporters that we ended up having to get an answering service. Imagine how embarrassing that would be for a sixth grader.” Today, at 76, he’s back in the spotlight, fielding calls from the media as researchers around the world race to develop new vaccines to stem the COVID-19 pandemic.

Source: Pitt Wire

Why So Many Americans Are Skeptical of a Coronavirus Vaccine

Oct 16 2020

In the face of nearly seven million infections and 200,000 deaths, many Americans refuse to wear masks because they don’t feel the coronavirus is real. Even some of those who believe the virus exists are not concerned about getting sick. How did this happen? Putting political ill will aside for a moment, the conflicting messaging that persisted from February through the summer could confuse even the most diligent information seeker. Recommendations from credible organizations swung like a pendulum. It sounded something like this: Coronavirus is not a threat to America. The CDC is requiring quarantine for any international travelers. Don’t touch surfaces. You don’t need a mask. The CDC isn’t requiring quarantine for travelers. Actually you do need to wear a mask, and surfaces aren’t as risky.

Source: Scientific American

Flu vaccine in kids reduces risk of related hospitalizations, study finds

Oct 15 2020

As health officials urge the public to get the flu shot in order to avoid potentially overloading the country’s hospitals with both influenza and coronavirus-related illnesses, a new study from the American Academy of Pediatrics (AAP) found that last year’s vaccine, which was estimated to be between 40% and 60% effective, actually reduced pediatric flu-related emergency room visits by as much as 51%, and hospitalizations by 40%.

Source: Fox News

Ensuring the Safety of COVID-19 Vaccines in the United States

Oct 15 2020

Currently, clinical trials are evaluating investigational COVID-19 vaccines in many thousands of study participants to generate scientific data and other information for the Food and Drug Administration (FDA) to determine their safety and effectiveness. These clinical trials are being conducted according to the rigorous standards set forth by FDA in their June 2020 guidance document, Development and Licensure of Vaccines to Prevent COVID-19external icon. If FDA determines that a vaccine meets its safety and effectiveness standards, it can make these vaccines available for use in the United States by approval or emergency use authorization. After FDA makes its determination, the Advisory Committee on Immunization Practices (ACIP) will review available data before making vaccine recommendations to CDC. Learn more about how CDC is making COVID-19 vaccine recommendations.

Source: CDC