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FDA Authorizes Emergency Use for Novavax COVID Vaccine for Ages 12 to 17
Biotechnology company Novavax announced on Friday that its COVID-19 vaccine has been authorized for emergency use by the U.S. Food and Drug Administration for adolescents between the ages of 12 and 17.
In July, Novavax’s two-dose COVID-19 vaccine for adults ages 18 and over got its emergency approval from the FDA.
Novavax was one of the original participants in the U.S. government’s race to develop a COVID vaccine in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Speed. However, the small Maryland biotech company struggled to quickly get manufacturing in place and its clinical trial data read out much later than rivals Pfizer or Moderna.
Dr. Peter Marks, a senior FDA official, has said that Novavax’s vaccine would potentially appeal to unvaccinated people who would prefer a shot that is not based on the messenger RNA technology used by Pfizer and Moderna.
Fauci Plans to Step Down in December After Half a Century in Government
Anthony S. Fauci, the nation’s preeminent infectious-disease expert who achieved unprecedented fame while enduring withering political attacks as the face of the coronavirus pandemic response under two presidents, plans to step down in December after more than a half-century of public service, he announced Monday.
Fauci, 81, has led the National Institute of Allergy and Infectious Diseases since 1984. He joined the parent agency, the National Institutes of Health, in 1968 as a 27-year-old doctor who had just finished medical residency and was quickly identified as a rising star. Most recently, Fauci has also served as President Biden’s chief medical adviser since the start of his administration.
While Fauci is one of the most cited researchers of all time and has been widely known in scientific circles for decades, it was the coronavirus pandemic that catapulted him to worldwide fame — and ignited criticism from some Republican politicians and threats from the public.
Pfizer Asks FDA to Authorize COVID Booster Shots That Target Omicron BA.5 for People Ages 12 and Older
Pfizer and its German partner BioNTech on Monday asked the Food and Drug Administration to authorize COVID booster shots that target the Omicron BA.4 and BA.5 subvariants for people ages 12 and older.
The updated vaccines would target the original strain of the virus that first emerged in Wuhan, China in 2019 as well as Omicron. Scientists and public health officials hope the new shots will provide broader and more durable protection against infection and mild illness.
Dr. Ashish Jha, the White House COVID response coordinator, has said the new shots will become available to the public by early to mid-September. Pfizer said it could ship the Omicron BA.4/BA.5 boosters as soon as the FDA authorizes them. The U.S. government has secured 105 million doses of Pfizer’s updated shots and 66 million doses of Moderna’s new vaccine.
New Virus Breakout Raises Question of Bioterrorism
Recently, the discovery of the “Langya virus” in the Shandong and Henan provinces of China has quickly attracted the attention of medical experts around the world. The virus is a type of zoonotic henipavirus and 35 people have been identified to be infected with this Langya virus since 2019 in these two provinces in China.
Notably, this virus is related to the Mojiang virus — found in the infamous Mojian Caves where the bat-borne coronavirus most similar to the SARS-CoV-2 was discovered.
The Wuhan Institute of Virology has become very interested in henipaviruses as of late, taking great pains to obtain and reconstruct the Nipah virus, which is not even a threat in China.
What does this all mean, and what is going on inside China’s military labs?
CDC Figures Show Just How Few Over-50s Have Had COVID Vaccine Boosters
Millions of eligible U.S. adults have not yet had a COVID booster vaccine, data from the Centers for Disease Control and Prevention (CDC) shows, as the U.S. heads into the winter.
The CDC recommended a COVID booster vaccine — an extra shot to boost immunity in people who had already been fully vaccinated against COVID — in some populations in September 2021. Access was further expanded to other populations before a recommendation for a second booster dose in March this year.
However, despite the rise of Omicron over the winter and the spread of the BA.5 variant, uptake of booster shots in the U.S. has been lackluster.
FDA Asks Pfizer to Test Second Paxlovid Course in Patients With COVID Rebound
The U.S. Food and Drug Administration (FDA) has asked Pfizer Inc. (PFE.N) to test the effects of an additional course of its antiviral Paxlovid among people who experience a rebound in COVID-19 after treatment, the regulator said on Friday.
The drugmaker must produce the initial results of a randomized controlled trial of a second course of the antiviral by Sep. 30 next year, the FDA told Pfizer in a letter dated Aug. 5.
The directive follows reports of recurrent viral infection or symptoms, or both, after the first course, including in President Joe Biden and National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci.
Omicron-Specific COVID Booster Shots Are Just Weeks Away. Here’s Who Will — and Won’t — Be Eligible
Newly updated COVID booster shots designed to target Omicron’s BA.5 subvariant should be available within the next three weeks. That begs an important question: Who’s going to be eligible to get them?
The short answer: Anyone ages 12 and up who has completed a primary vaccination series, a Centers for Disease Control and Prevention spokesperson tells CNBC Make It. It’s unlikely to matter whether you’ve received any other booster doses or not before, the spokesperson says — but if you’re unvaccinated, you won’t be eligible for the updated formula until you complete a primary series with the existing COVID vaccines.
The longer answer is somewhat more complex because it depends on which booster shots get approved and when.
LA Public Health Department Faces Backlash After Offering COVID Test to Animals, Including Seals
The Los Angeles Public Health Department is facing growing criticism over its decision to offer free COVID-19 testing for animals, despite there being no positive cases reported among animals in the area.
LA Public Health announced the initiative on Aug. 20 and said it has received funding from the Council of State and Territorial Epidemiologists and the Centers for Disease Control and Prevention (CDC) to monitor COVID-19 in animals in Los Angeles County.
Out of the 177 animals that have been tested in Los Angeles County so far, including dogs, cats, bats, raccoons, skunks, rats and sea lions, none have tested positive for COVID-19 as of Aug. 18.
U.K. COVID Inquiry Bill Already at £85m as Government Hires Top Law Firms
Bills for the COVID-19 public inquiry have already hit £85m despite hearings not starting until next year after the government hired top legal and public relations firms.
Departments making key decisions during the pandemic have hired leading law firms on multimillion-pound contracts alongside specialist firms tasked with sifting through millions of sensitive documents and emails for disclosure.
The early outlays of public funds suggest the U.K.-wide inquiry into the response to and impact of the pandemic will be one of the most expensive ever statutory public inquiries.
Amid COVID Surge, Iran Cut Corners to Approve yet-Unproven Vaccine
As Iranian regulators considered endorsing a locally developed coronavirus vaccine a year ago, a top health official issued a stern warning, saying the test results were insufficient and the vaccine’s approval could undermine efforts to contain the country’s raging epidemic.
But the vaccine had influential backers. It was the highly touted project of a company called Barkat, part of a sprawling corporate empire close to Iran’s supreme leader, Ayatollah Ali Khamenei.
Less than a week later, Health Minister Saeed Namaki announced that the vaccine had received emergency approval. At the time, Barkat had not even begun its Phase 3 clinical trial, meant to confirm the vaccine’s effectiveness and identify possible side effects, Iranian researchers later reported in a medical journal. That trial started two days later, the researchers said. The results are still not public.
Hundreds of Thousands of Expired U.S. Monkeypox Shots Still Viable, Tests Reveal
Four hundred thousand doses of the monkeypox vaccine that had expired and were destined to be destroyed have been tested from American stockpiles and found to still be viable, the chief executive of vaccine manufacturer Bavarian Nordic told POLITICO.
The Danish firm is carrying out tests, at the request of the United States, on some of the 28 million doses that expired around two years ago, Bavarian Nordic boss Paul Chaplin said in an exclusive interview. So far the news is good. The youngest batches of expired doses remain of a high quality with vaccine levels at sufficient concentrations. Tests are ongoing but up to 1 million doses could pass muster from the batches now being analyzed, Chaplin said.
There’s now “ongoing dialogue” with the U.S. Food and Drug Administration (FDA) on how to extend the shelf life of those batches to allow the Biden administration to distribute them, Chaplin said.
