Americans apparently trust healthcare professionals more than FDA, CDC

[Image from Pixaby]

As the U.S. tries to reach a post-COVID-19 pandemic “normal,” Americans are placing more trust in nurses and doctors than agencies such as the CDC and FDA, according to a new survey from the Robert Wood Johnson Foundation and Harvard T.H. Chan School of Public Health.

The survey took place Feb. 11 – March 15, 2021 among a nationally representative, probability-based sample of 1,305 adults. Go to our sister site Medical Design & Outsourcing to find out more about the results. 

Read more
  • 0

FDA, CDC lift pause on J&J COVID-19 vaccine

This 2020 image shows a vial of J&J vaccine when it was investigational. Image from Johnson & Johnson.

The FDA and CDC have lifted the pause placed on the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine after reports of blood clots caused concern.

On April 13, the FDA and CDC issued a joint statement recommending the pause in the administration of the J&J (Janssen) COVID-19 vaccine after, among 6.8 million doses delivered in the U.S., six recipients experienced cases of a rare and severe type of blood clot. Of those blood clot cases, one death was recorded.

Get the full story at our sister site, Pharmaceutical Processing World.

Read more
  • 0

Pfizer to boost vaccine production for U.S. by 10%

Image courtesy of Wikipedia

Pfizer will deliver 10% more of its COVID-19 vaccine to the U.S. by the end of May than originally planned, its CEO tweeted yesterday.

The tweet follows the federal government’s decision to recommend a temporary halt in the distribution of Johnson & Johnson’s single-dose vaccine, which has been tied to rare instances of blood clot formation in women.

Pfizer will deliver 220 million doses of its two-dose vaccine by the end of May and supply the full 300 million it agreed to for the end of July two weeks early, CEO Albert Bourla tweeted. “In the fight against COVID-19, we’re in this together,”  he added.

As of Monday, more than 6.8 million doses of the J&J single-dose vaccine had been administered in the U.S. Among recipients of those doses, six cases of a rare and severe type of blood clot have been reported. The CDC and FDA are reviewi…

Read more
  • 0

Feds halt J&J COVID-19 vaccine due to blood clot concern

The FDA and CDC issued a joint statement today recommending the pause in the administration of the Johnson & Johnson COVID-19 vaccine.

As of yesterday, more than 6.8 million doses of the J&J single-dose vaccine had been administered in the U.S. Among recipients of those doses, six cases of a rare and severe type of blood clot have been reported. The CDC and FDA are reviewing data involving these cases.

Get the full story at our sister site, Drug Discovery & Development.

Read more
  • 0

Feds halt Johnson & Johnson COVID-19 vaccine due to blood clot concern

The FDA and CDC issued a joint statement today recommending the pause of administration of the Johnson & Johnson COVID-19 vaccine.

As of yesterday, more than 6.8 million doses of the J&J single-dose vaccine had been administered in the U.S. Among those doses, there have been six reported U.S. cases of a rare and severe type of blood clot in individuals who received the vaccine. The CDC and FDA are reviewing data involving these cases.

In such cases, a form of blood clot known as cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia), according to the joint statment. All six cases were in women between ages 18 and 48, with symptoms occurring between six and 13 days after vaccination.

Treatment for CVST is different from that which may typically be administered, which is an anticoagulant drug called heparin. In these cases, heparin may be dangerous and alternative treatments are needed,…

Read more
  • 0

Pfizer and Moderna COVID-19 vaccines 90% effective in real-world study

[Photo by Daniel Schludi on Unsplash]

A single dose of Pfizer or Moderna vaccine is about 80% effective at preventing COVID-19 infection at least two weeks after injection. The efficacy level rises to 90% two weeks after the second dose of either mRNA vaccine, according to a recent CDC study involving roughly 4,000 essential workers.

In contrast to the Phase 3 trials from Pfizer-BioNTech and Moderna, the CDC study analyzed vaccines’ ability to prevent COVID-19 infection. Study participants underwent weekly COVID-19 testing for 13 consecutive weeks.

Conversely, the Pfizer-BioNTech and Moderna Phase 3 trials sought to analyze their vaccines’ ability to prevent symptomatic COVID-19 disease. Participants in the Pfizer had to have at least one COVID-19 symptom before they received a SARS-CoV-2 test. Study volunteers in the Moderna trial had to have at least two systemic symptoms or one respiratory symptom …

Read more
  • 0

Is COVID-19 herd immunity elusive or within reach?

This transmission electron microscope image shows SARS-CoV-2 – the virus that causes COVID-19 – isolated from a patient in the U.S. Image courtesy of NIAID

Last year, herd immunity seemed like a comforting promise as researchers worked on dozens of COVID-19 vaccine candidates and a silver-lining to the rampant spread of the virus — the more people who got infected, the more natural immunity that would develop over time.

There are now dissenting opinions about how the term relates to the current pandemic and the role of vaccines in achieving it.

A Wall Street Journal op-ed recently opined that herd immunity is just around the corner, thanks mainly to natural immunity. Meanwhile, former FDA commissioner Dr. Scott Gottlieb and The Atlantic argued the U.S. might never reach herd immunity against SARS-CoV-2. Meanwhile, the consulting firm McKinsey suggests that herd immunity could be within reach in late 2…

Read more
  • 0

Feds to spend $1.6B to expand COVID testing, domestic manufacturing

(Image from the CDC)

The Biden administration announced plans today to expand COVID-19 testing across the country, boost domestic manufacturing of tests and testing supplies and increase virus genome sequencing to detect virus variants.

The departments of Health and Human Services and Defense will jointly invest $650 million to expand testing for K-8 schools and underserved congregate settings, such as homeless shelters, directly through new regional coordination “hubs.” The move will also include working with laboratories, including at universities, to collect specimens, perform the tests and report results to the relevant public health agencies for up to 25 million additional tests per month.

Get the full story on our sister site, Medical Design & Outsourcing.

Read more
  • 0

Norway investigating deaths of 23 individuals who received COVID-19 vaccine

Image from Mark König on Unsplash

In Norway, authorities are investigating the deaths of nearly two dozen people who received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

To date, it has analyzed data from 13 of those individuals.

The Norwegian Medicines Agency concluded that common adverse reactions to mRNA vaccines, including fever and nausea, could have contributed to deaths in elderly and frail patients.

Get the full story from our sister site, Drug Discovery & Development.

Read more
  • 0

Norway investigating deaths of 23 individuals who received COVID-19 vaccine

Image from Mark König on Unsplash

In Norway, authorities are investigating the deaths of nearly two dozen people who received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

To date, it has analyzed data from 13 of those individuals.

The Norwegian Medicines Agency concluded that common adverse reactions to mRNA vaccines, including fever and nausea, could have contributed to deaths in elderly and frail patients.

The agency said in a statement that it had expected deaths close to the time of vaccination, given its plan to vaccinate elderly patients, many of whom have “serious underlying diseases.” Some 400 people in Norway die each week in nursing homes and long-term care facilities.

While it is clear that elderly individuals have a higher risk of mortality from all causes, it will take time to determine what role a vaccine might play, said Updesh Dosanjh, practice le…

Read more
  • 0

Report: U.S. should have enough COVID-19 vaccine in Q3 2021, CDC head tells Senate panel

CDC director Dr. Robert Redfield told a Senate panel today that the federal government should have enough coronavirus vaccine for Americans to resume “regular life” by the third quarter of 2021, according to a report by CNBC.

Redfield said vaccinations could begin November or December of 2020 and that it could take 6 to 9 months to inoculate all Americans, the network reported.

“If you’re asking me when is it going to be generally available to the American public so we can begin to take advantage of vaccine to get back to our regular life, I think we’re probably looking at third … late second quarter, third quarter 2021,” Redfield told the U.S. Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies.

The Trump administration today released a plan to distribute an eventual COVID-19 vaccine free of charge, initially to targeted groups and more broadly as supply increases. The government is p…

Read more
  • 0