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CDC Recommends Novavax’s COVID Shots as Mix-and-Match First Booster to Pfizer or Moderna
The Centers for Disease Control and Prevention on Wednesday recommended Novavax COVID boosters for adults in the U.S., including for people who received Pfizer, Moderna or Johnson & Johnson‘s shots as their primary series.
The CDC gave the final go-ahead for pharmacies to start administering the Novavax boosters just hours after the Food and Drug Administration had authorized the shots. Dr. Evelyn Twentyman, a CDC official, announced the Novavax recommendation during a meeting of the agency’s independent vaccine experts Wednesday afternoon.
The CDC recommended Novavax’s boosters without a debate or vote from its independent experts.
The company’s shares jumped by almost 6% in morning trading but were flat by noon.
CDC Could Add COVID Vaccine Requirement for Children to Immunization List With ‘No Clinical Data’: Dr. Makary
Johns Hopkins School of Medicine professor Dr. Marty Makary told “Tucker Carlson Tonight” Tuesday it will be the first vaccine added “with no clinical data.”
“There has never been a vaccine added to the child immunization schedule without solid clinical evidence that it reduces disease significantly in the community,” he said. Makary added that the CDC only has data from eight mice on the effects of the Omicron vaccine in young people. White House Coronavirus Response coordinator Dr. Ashish Jha has seen the data on the vaccines’ effects, according to Makary, but it is not publicly available.
If the CDC’s ACIP puts the COVID-19 vaccine on the child immunization schedule, children could be required to get it in order to attend school. The Johns Hopkins professor told host Tucker Carlson, 1 in 5,000 vaccine doses result in a “severe adverse event.” Makary added that it will be up to states to implement the policy if the ACIP passes the vaccine requirement.
Scientists, Doctors, Parents Speak out About Harms of COVID Vaccines
Just one day after she got a COVID-19 booster shot, Regan Lewis, a 20-year-old nursing student at Colby Community College in Colby, Kansas, had a heart attack. Her mom, Connie Werth Lewis, desperately asked for prayers for her daughter in a public post on Facebook. That night, Regan Lewis died.
As of Oct. 7, 31,470 deaths have been reported to the Centers for Disease Control and Prevention and Food and Drug Administration via their Vaccine Adverse Events Reporting System, a passive post-market surveillance system designed to help government officials and researchers pick up safety signals about vaccines.
At a recent Sedona conference (where Jennifer Margulis also was a speaker) several physicians pointed out that there has been a growing number of “unexplained” sudden deaths among young people who have received COVID-19 injections as well as booster shots.
That point was made by several of the speakers, including Dr. Sherri Tenpenny, a physician based in Cleveland; and Dr. Jeffrey Barke, a medical doctor in private practice in California. These untimely, age-inappropriate deaths, they pointed out, often were the immediate result of heart dysfunction, blood clots or seizures. But, they said, where there was a history of prior COVID-19 injection, the health condition that ostensibly led to death may actually have been caused by the shots.
Audit Hits N. Dakota on Vaccine Handling; Agency Disputes It
The North Dakota Health Department stored thousands of COVID-19 vaccine doses at incorrect temperatures or without temperature data over the past two years, according to a state audit Tuesday that said some of the vaccines were administered to patients.
The health department disputed the findings. Tim Wiedrich, who heads the agency’s virus response, said: “no non-viable vaccine” was given to patients. In responses that accompanied the audit, the department said clerical errors or other errors of documentation erroneously suggested that expired or bad doses were given.
The state analysis said nearly 2,000 Moderna doses were stored at incorrect temperatures and were administered to patients. The audit also found that nearly 13,000 doses of the Pfizer vaccines were issued from storage with missing temperature data. The audit covered a two-year span that ended on June 30. An inventory of the vaccines was conducted on Aug. 8, 2021, the audit said.
Biden’s Plan for Next Pandemic Eyes Vaccine Supply Within 130 Days
President Joe Biden’s strategy for the next deadly pandemic calls for the U.S. to produce a test for a new pathogen within 12 hours of its discovery and enough vaccine to protect the nation within 130 days.
Those instructions are outlined in the administration’s plan to defend against biological threats, from naturally occurring infectious diseases to man-made weapons of mass destruction. Known as the National Biodefense Strategy, the new framework seeks to better define the government’s responsibilities, objectives and deadlines in a crisis and places the White House at the center of the response.
Addiction Drug Shows Promise Lifting Long COVID Brain Fog, Fatigue
Lauren Nichols, a 34-year-old logistics expert for the U.S. Department of Transportation in Boston, has been suffering from impaired thinking and focus, fatigue, seizures, headache and pain since her COVID-19 infection in the spring of 2020.
Last June, her doctor suggested low doses of naltrexone, a generic drug typically used to treat alcohol and opioid addiction.
Researchers chasing long COVID cures are eager to learn whether the drug can offer similar benefits to millions suffering from pain, fatigue and brain fog months after a coronavirus infection.
The drug has been used with some success to treat a similar complex, post-infectious syndrome marked by cognitive deficits and overwhelming fatigue called myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
XBB, BQ.1.1, BA.2.75.2 — A Variant Swarm Could Fuel a Winter Surge
For two years, coronavirus variants emerged, one by one, sweeping the globe. But this fall and winter are expected to be different: Instead of a single ominous variant lurking on the horizon, experts are nervously eyeing a swarm of viruses — and a new evolutionary phase in the pandemic.
This time, it’s unlikely we will be barraged with a new collection of Greek alphabet variants. Instead, one or more of the multiple versions of the omicron variant that keep popping up could drive the next wave. They are different flavors of Omicron, but eerily alike — adorned with a similar combination of mutations. Each new subvariant seems to outdo the last in its ability to dodge immune defenses.
“It is this constant evolutionary arms race we’re having with this virus,” said Jonathan Abraham, an assistant professor of microbiology at Harvard Medical School.
Will EU Prosecutor’s COVID Vaccine Probe Ensnare Von Der Leyen?
It’s the scandal that won’t go away — and produces more intrigue than answers. The EU’s public prosecutor’s office on Friday said it was investigating the EU’s purchase of coronavirus vaccines during the pandemic’s peak.
Yet the cagey announcement offered almost no details — nothing on whom it was investigating, what potential crimes it was looking for or why it had taken the step now. Enter the Brussels speculation machine. Its top chatter: Ursula von der Leyen’s texts.
For months, pressure has been piling up on the European Commission president since her admission that she swapped texts with Pfizer Chief Executive Albert Bourla while the EU was negotiating its vaccine contract with the company. Two EU watchdog agencies have already chided her over the matter, venting over the Commission’s refusal to produce the texts.
In April 2021, von der Leyen told the New York Times that she had traded texts with the Pfizer CEO for a month in the run-up to the EU signing its contract with the U.S. pharmaceutical giant. In the deal, the Commission committed to buying 900 million Pfizer-BioNTech shots on behalf of EU members, with an option to purchase another 900 million. The remarks prompted chatter about whether von der Leyen had freelanced during the contract negotiations and circumvented normal channels.
Roche’s COVID Drugs Tumble $1 Billion as New Eye Launch Vabysmo Rushes to Counter Biosimilar-Hit Lucentis
Roche’s COVID-19 therapies Ronapreve and Actemra gave the drugmaker a sales boost a year ago amid a surge in infections. But as cases ebb and new coronavirus variants emerge, sales of the drugs are falling sharply.
Sales from Regeneron-partnered COVID antibody Ronapreve and anti-inflammation med Actemra slid nearly 1 billion Swiss francs year over year in the first nine months of 2022. About 900 million Swiss francs of the drop happened in the third quarter alone, Roche CEO Severin Schwan said during a conference call Tuesday.
Ronapreve’s revenue was nearly wiped out with a 92% decline to just 22 million Swiss francs in the third quarter. And Actemra sales plummeted 42% during the same period to 584 million Swiss francs.
Uganda to Deploy Ebola Vaccine in 2 Weeks, Says WHO Official
Experimental Ebola vaccines will be deployed in Uganda in about “two weeks,” a World Health Organization official said Wednesday, as the East African country carried out tough preventive measures that include a lockdown in the Ebola-hit areas.
Potentially hundreds of thousands of trial vaccine doses will buttress a response effort that still must focus on tracing Ebola contacts and community engagement, Dr. Yonas Tegegn Woldemariam, the WHO representative in Uganda, told The Associated Press.
Vaccines developed by the U.S.-based Sabin Vaccine Institute and Oxford University “are ready to be shipped” to Uganda, which is finalizing protocols for the study before the National Drug Authority issues import permits, he said.
WHO Forced to Ration Vaccine as Cholera Cases Surge Worldwide
A “dire shortage” of cholera vaccines amid an unprecedented rise in global cases has forced health officials to halve the number of doses given to people in outbreak hotspots, the World Health Organization has said.
The “exceptional decision” to reduce the number of doses from two to one would allow for the vaccines to be eked out until the end of the year and given to more people in more countries, the WHO said today.
The organization conceded the move would inevitably lead to a “reduction and shortening of immunity”, adding: “The one-dose strategy has proven to be effective to respond to outbreaks, even though evidence on the exact duration of protection is limited, and protection appears to be much lower in children.”