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German Panel Recommends COVID Shot Only for at-Risk Youngsters
Germany’s vaccine advisory panel on Thursday recommended that Pfizer-BioNTech’s (PFE.N) COVID-19 vaccine for children from six months to four years should only be given routinely to those at risk of severe disease from the infection.
The head of the panel of 18 appointees, known as STIKO, said there was no clear case for broad use, citing a lack of data to rule out any rare side effects and no signs of the infection causing severe illness in otherwise healthy children.
The recommendation also covers a version of Moderna‘s (MRNA.O) Spikevax vaccine for the age group but that product is in short supply in Germany at the moment, the expert panel said.
STIKO, which is widely followed by physicians in Germany, added that vaccination was not called for to prevent young children from passing the virus on to other vulnerable people among family and friends. Parents seeking a shot for their children for that reason could do so after consulting their pediatrician, but a shot would not provide sufficient protection for a child’s contacts against infection with the prevailing Omicron variant.
FDA Oversight of Clinical Trials Is ‘Grossly Inadequate,’ Say Experts
COVID-19 vaccines and drugs were developed at “warp speed” and now experts are concerned that the U.S. Food and Drug Administration inspected too few clinical trial sites. On Sept. 25, 2020, the U.S. Food and Drug Administration (FDA) received a complaint from Brook Jackson who had been working for Ventavia Research Group, a Texas-based company hired to run clinical trials for Pfizer’s COVID-19 mRNA vaccine.
Jackson, a regional director, had witnessed problems at three trial sites she was overseeing and complained to an FDA inspector about a range of problems including falsified data, unblinded patients, and inadequately trained vaccinators who were slow to follow up on adverse events. “I thought that the FDA was going to swoop in and take care of everything. What I was reporting was so important,” Jackson told The BMJ. The FDA did not, however, inspect the trial sites in question.
This lack of oversight was not an isolated case, The BMJ has learnt. Regulatory documents show that only nine out of 153 Pfizer trial sites were subject to FDA inspection before licensing the mRNA vaccine. Similarly, only 10 out of 99 Moderna trial sites and five of 73 remdesivir trial sites were inspected.
Now, facing a backlog of site inspections, experts have criticized the FDA’s oversight of clinical trials, describing it as “grossly inadequate.” They say the problem, which predated COVID-19, is not limited to a lack of inspections but also includes failing to notify the public or scientific journals when violations are identified — effectively keeping scientific misconduct from the medical establishment.
Coalition Calls for Increased CDC Oversight
The Health Innovation Alliance on Tuesday called on congressional leadership to pass legislation that would increase accountability for the Centers for Disease Control and Prevention (CDC) and other public health agencies.
“Not only has the CDC been provided an extensive amount of additional funding for COVID-19 response, but the agency failed to update and modernize its response plans and systems as required by Congress in 2006, and again twice since then,” the group’s Executive Director Joel White wrote in a letter addressed to top lawmakers.
The CDC has faced intense scrutiny amid the COVID-19 pandemic, receiving criticism for slow responses and unclear guidance, among other missteps.
Pediatric Health Groups Call for National Emergency to Fight Respiratory Illnesses
Pediatric health provider groups are calling on the Biden administration to declare a national emergency to help them combat the surge of hospitalizations due to respiratory illnesses in children.
In a letter sent to President Biden and Health and Human Services Secretary Xavier Becerra, the Children’s Hospital Association and the American Academy of Pediatrics said a dual declaration of a national emergency along with a public health emergency is needed.
“We need emergency funding support and flexibilities along the same lines of what was provided to respond to COVID surges,” the organizations wrote.
Doctors Are Running out of Antibody Drugs to Treat COVID as Virus Mutates
COVID-19’s constant mutations have proven nearly impossible for drugmakers to keep up with. Omicron’s newest stepchildren threaten to render the last two antibody drugs on the market ineffective: Eli Lilly & Co.’s bebtelovimab, which is used to treat symptoms, and AstraZeneca Plc’s Evusheld, which helps prevent infections.
When COVID first hit, scientists quickly developed antibody drugs to protect people from the virus’s worst effects. It’s a straightforward premise: a targeted antibody can immediately neutralize a threat inside the body, preventing an infection from even starting.
But with each new round of COVID mutations, various antibody drugs have been deemed ineffective and pulled off the market. And with very little progress in antibody drug development, it’s quite possible doctors will soon have none to choose from.
The problem is worldwide. U.K. health officials said Wednesday in updated draft guidance that Evusheld isn’t recommended for COVID treatment due to uncertainty about its effectiveness against Omicron. The only drugs still recommended for use are Pfizer Inc.’s Paxlovid antiviral; Lilly’s Olumiant, subject to U.K. marketing authorization; and Roche Holding AG’s RoActemra, according to the National Institute for Health and Care Excellence. The guidance will not be finalized until 2023.
COVID Pandemic Led to Surge in Superbug Infections, EU Agency Says
Infections from some antibiotic-resistant pathogens known as superbugs have more than doubled in healthcare facilities in Europe, an EU agency said on Thursday, providing further evidence of the wider impact of the COVID-19 pandemic.
The European Center for Disease Prevention and Control report said reported cases of two highly drug-resistant pathogens increased in 2020, the first year of the COVID-19 pandemic, then sharply jumped in 2021.
Data showed that in Europe last year, reported cases of the Acinetobacter bacteria group more than doubled compared with pre-pandemic annual numbers. Cases of another bacteria, Klebsiella pneumoniae, which is resistant to last-resort antibiotics, jumped by 31% in 2020 and by 20% in 2021.
Some scientists link the rise in hospital-acquired superbug infections during the pandemic to wider antibiotic prescriptions to treat COVID-19 and other bacterial infections during long hospital stays.
U.S. Home Births Rise in Pandemic, to Highest Level in Decades
U.S. home births increased slightly in the pandemic’s second year, rising to the highest level in decades, according to a government report published Thursday.
Among almost 4 million births in 2021, nearly 52,000 occurred at home, the Centers for Disease Control and Prevention report showed. That’s up about 12% from 2020, following a 22% rise from 2019 to 2020.
Increases were seen across races and ethnicities, although home births were much less common among Hispanic women than others.
Researchers May Have Discovered a Breakthrough Vaccine for Fentanyl — the Drug at the Center of the Opioid Crisis
A group of researchers found a potential vaccine to block fentanyl from entering the brain. Fentanyl, a synthetic opioid that’s 50 to 100 times stronger than morphine, was introduced as a pain management remedy in the 60s; but overdoses on the opioid have increased dramatically in recent years.
Deaths from synthetic opioids, not including methadone, increased by over 50% between 2019 and 2020, largely due to the increase in illicit manufacturing of fentanyl, where it can be laced into other illegal drugs to make them more potent and cheaper. Just two milligrams of fentanyl can be fatal, depending on the person’s size and tolerance. Synthetic opioid overdoses lead to over 150 deaths every day.
A team at the University of Houston that developed the new vaccine say it could affect fentanyl’s impact on the brain, eliminating the euphoric feelings it produces. They published their findings in the journal Pharmaceutics.
EU Secures up to 2 Million Monkeypox Vaccine Doses From Bavarian Nordic
The European Union said on Thursday it had secured supply of up to 2 million doses of a monkeypox vaccine from Danish company Bavarian Nordic (BAVA.CO) for the next two years.
The joint procurement will allow 14 countries, including EU member states, western Balkan countries and those in the European Economic Area to purchase the vaccine.
About 700,000 doses are expected to be delivered in 2023.
Ebola Shots Donated by Merck to Be Tested on Vaccine-Resistant Strain
Ebola vaccine that Merck & Co. donated to an international immunization group will be part of a trial testing three shots against a resistant strain of the deadly virus that’s spreading in Uganda.
The vaccine, now licensed to the International AIDS Vaccine Initiative in New York, was recommended for testing alongside experimental shots from the Washington-based Sabin Vaccine Institute and the University of Oxford’s Jenner Institute, the World Health Organization said Wednesday in a statement. The worldwide health agency will run the trial in cooperation with Uganda’s Ministry of Health, which accepted the WHO recommendation.
Merck had enough vaccine ingredient in its freezers to make about 100,000 doses, all of which has been donated to IAVI, Feinberg said. IAVI will make approximately 75,000 doses available to the WHO, aiming to have them in Uganda by early December. Under its license, the group has also made its own doses along with a manufacturing partner, which IAVI expects to perform similarly to Merck’s.
