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HHS Sued by Watchdog for Info on COVID Vaccine Side Effects: ‘Unlawful Stonewall’
Legal watchdog Judicial Watch filed a Freedom of Information Act (FOIA) lawsuit Thursday against the Department of Health and Human Services after the department did not provide requested information and communications about COVID-19 vaccine side effects.
The lawsuit comes after the Food and Drug Administration was unresponsive to Judicial Watch’s Aug. 30, 2021 FOIA request that asked for all emails “sent to and from members of the Vaccines and Related Biological Products Advisory Committee regarding adverse events, deaths and/or injuries caused by investigatory vaccines for the prevention or treatment of SARS-CoV-2 and/or COVID-19 currently produced by Pfizer/BioNTech, Moderna and/or Johnson & Johnson.”
The FDA never got back to the group with the requested records by the Oct. 18, 2021 deadline, according to the lawsuit filed Thursday.
The government accountability group said that, through their lawsuit, is aiming to “promote transparency, integrity, and accountability in government and fidelity to the rule of law” and provide more information to the American people on any other possible side effects of the vaccine.
Moderna Chief: Getting Children Under Five COVID Vaccines One of ‘Highest Priorities’
“It’s really one of our highest priorities,” Paul Burton, chief medical officer, said, “We’re working around the clock and our teams are on it all the time.”
His comments came just one day after Moderna announced on Wednesday that it would seek emergency authorization of its coronavirus vaccine for children younger than 6, after preliminary data showed kids in that age group had a similar immune response to adolescents and young adults when given a smaller dose of the vaccine.
However, Moderna said the vaccine was only about 44 percent effective at preventing symptomatic infection in children 6 months to 2 years old, and 37 percent effective in children aged 2 through 5.
Cornell University Reports Indications of ‘Substantial Prevalence’ of COVID on Campus
As new case totals begin to tick up in the state of New York, the campus is once again reporting a viral resurgence. This week, Cornell University elevated its COVID-19 alert system to “yellow,” indicating that transmission is rising, and prevalence of the virus is above predicted levels.
Between March 17 and March 23, Cornell recorded 515 positive COVID-19 infections among students, staff and faculty, according to data from the university.
Data shows 97% of the student population is vaccinated, while 92% of those eligible are boosted.
‘Forgotten’ Parents of Kids Under 5 Push FDA to Clear Moderna Shot
On Wednesday, Moderna said that two shots — each a quarter of the adult dose — produced a strong immune response in children under 6, according to preliminary results of a study of 6,700 young children. But efficacy in preventing symptomatic infection was underwhelming, ranging from 44% for the youngest kids down to 38% for those aged 2 to 5 years. Moderna shares closed down over 4% Wednesday.
In its statement, Moderna said that the trial data identified no new side effect concerns or other red flags. Fever occurred in fewer than 1 in 5 of the younger kids. The data hasn’t been published in a scientific journal or reviewed by outside experts, and Moderna didn’t release detailed efficacy or side effect results.
There were no severe COVID cases in Moderna’s trial, which means there is no information on the most important outcome: Whether the shot prevents hospitalization and death in the youngest cohort.
Moderna’s efficacy numbers are hardly spectacular, but Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said in a White House briefing Wednesday that 44% was not such bad news.
Drugmakers, Scientists Begin the Hunt for Long COVID Treatments
After producing vaccines and treatments for acute COVID-19 in record time, researchers and drugmakers are turning to finding a cure for long COVID, a more elusive target marked by hundreds of different symptoms afflicting millions of people.
Leading drugmakers, including those who have launched antiviral pills and monoclonal antibodies for COVID-19, are having early discussions with researchers about how to target the disease, five scientists in the United States and UK told Reuters.
Companies including GlaxoSmithKline (GSK.L), Vir Biotechnology (VIR.O) and Humanigen (HGEN.O) confirmed they had spoken to researchers on trials using their current treatments against long COVID. Others including Pfizer (PFE.N) and Roche (ROG.S) said they are interested but would not elaborate on plans.
Novavax Announces Participation in Two Booster Studies Using Its COVID Vaccine
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its protein-based COVID-19 vaccine, is included in two trials now underway to evaluate its vaccine‘s safety, immunogenicity, and reactogenicity as a booster amidst the ongoing COVID-19 pandemic.
Both studies have initiated participant enrollment and will help to extend knowledge of how a range of vaccines, including Novavax’ COVID-19 vaccine, can be used as boosters following primary immunization.
CDC Updates COVID Guidance to Allow Patients to Wear N95s
The Centers for Disease Control and Prevention on Thursday updated its guidance so that people visiting healthcare facilities are allowed to wear highly protective masks such as N95s.
The change comes after a POLITICO report last week found that hospitals around the country routinely ask patients and visitors to wear a surgical mask instead of their own N95.
The nation’s public health agency now says on its website that people should “use the most protective form” of masks. While facilities can continue to offer patients surgical masks, facilities “should allow the use of a clean mask or respirator with higher-level protection by people who chose that option based on their individual preference.”
Experts Worry About How U.S. Will See Next COVID Surge Coming
As coronavirus infections rise in some parts of the world, experts are watching for a potential new COVID-19 surge in the U.S. — and wondering how long it will take to detect.
Despite disease monitoring improvements over the last two years, they say, some recent developments don’t bode well:
As more people take rapid COVID-19 tests at home, fewer people are getting the gold-standard tests that the government relies on for case counts. The Centers for Disease Control and Prevention will soon use fewer labs to look for new variants. Health officials are increasingly focusing on hospital admissions, which rise only after a surge has arrived. A wastewater surveillance program remains a patchwork that cannot yet be counted on for the data needed to understand coming surges.
How We Got Herd Immunity Wrong
Herd immunity was always our greatest asset for protecting vulnerable people, but public health failed to use it wisely. In March 2020, not long after COVID-19 was declared a global public health emergency, prominent experts predicted that the pandemic would eventually end via herd immunity.
Infectious disease epidemiologist Michael Osterholm, who advised President Biden, opined in the Washington Post that even without a vaccine, SARS-CoV-2, the virus that causes COVID-19, would eventually “burn itself out as the spread of infection comes to confer a form of herd immunity.”
The best strategy, he reasoned, was to “gradually build up immunity” by letting “those at low risk for serious disease continue to work” while higher-risk people sheltered and scientists developed treatments and, hopefully, vaccines.
Early Research Suggests Your Risk of Getting COVID in the Next Wave Is Lower if You Already Had Omicron. Here’s Everything We Know About BA.2 Reinfections.
Because COVID-19 infections are on an uptick right now, many who’ve been infected in recent months are wondering: could I get Omicron again? The short answer is: probably not. Here’s what we know so far:
Political Stalemate Could Push COVID Vaccines Onto the Private Markets
A Washington, DC, stalemate could push COVID-19 vaccines into the commercial markets in the U.S. earlier than expected, limiting access for the uninsured and throwing Moderna into private market competition for the first time in its history.
White House officials have issued increasingly dire warnings in recent days that the U.S. hasn’t bought enough vaccine doses for another booster round, and that Congress must authorize more spending in order to supply additional doses.
Up until this point, all COVID-19 vaccines distributed in the U.S. have been bought and paid for by the federal government. If the FDA does authorize a fourth dose, and if Congress chooses not to pay, the vaccines could move to the private market, where they would be bought and paid for like any other pharmaceutical.
“We were always planning that this will happen one day,” said Moderna’s CEO, Stéphane Bancel. “And so, the commercial team that we have been hiring over the last two years… is actually working assuming there is a scenario where there is no funding with the U.S. government.”
Many in Malaysia to Lose Fully Vaccinated Status if They Don’t Get COVID Booster
Some two million recipients of the COVID-19 vaccine by Sinovac are set to lose their fully vaccinated status if they do not receive their boosters by April 1, said Malaysia’s Health Minister Khairy Jamaluddin.
“Based on the latest data, about 2.09 million recipients of the Sinovac vaccine for their primary series have yet to get their booster shots,” he told a press conference in Parliament on Thursday (March 24). “They will stand to lose their fully vaccinated status when the deadline ends.”
Mr. Khairy also said that those who had yet to get their Sinovac booster would be deemed “not fully vaccinated” by Singapore.
Australia to Roll out Fourth COVID Vaccine Shot Ahead of Winter
Australia will roll out a fourth dose of COVID-19 vaccines to its most vulnerable population starting next month, authorities said on Friday, as the country looks to limit fresh outbreaks ahead of winter.
A second booster shot will be offered from April 4 to people who had their previous booster shot at least four months ago and are over 65 years, Indigenous Australians over 50, people with disability or severely immunocompromised, Health Minister Greg Hunt said during a media briefing.