Covid News Watch
Sanders Tells Moderna Planned COVID Vaccine Price Hike Is ‘Unacceptable Corporate Greed’ + More
Sanders Tells Moderna Planned COVID Vaccine Price Hike Is ‘Unacceptable Corporate Greed’
Sen. Bernie Sanders (I-Vt.) is calling on Moderna not to quadruple the price of its COVID-19 vaccine, saying Tuesday that the plan amounts to “unacceptable corporate greed.”
In a Tuesday letter sent to Moderna CEO Stéphane Bancel, Sanders urged the company to reconsider its decision and refrain from any price increase “in light of the role the federal government has played in the development of the vaccine.”
Sanders, the incoming chairman of the Senate Health Committee, said the company’s decision to charge up to $130 a dose once the shots move to the commercial marketplace is “outrageous” and will cost taxpayers billions of dollars.
Bancel told The Wall Street Journal on Monday that Moderna is considering charging between $110 to $130 per dose in the U.S. when the government’s contract ends and the vaccine shifts to commercial distribution.
Deadline Passes for Pfizer to Submit Results of Post-Vaccination Heart Inflammation Study to U.S. Regulators
The deadline has passed for Pfizer to submit the results of a study exploring the frequency of heart inflammation following receipt of the company’s COVID-19 vaccine. Pfizer was required by the U.S. Food and Drug Administration (FDA) to conduct multiple studies on its vaccine after the FDA approved the shot in August 2021 because regulators determined that without the studies, there would not be sufficient data to assess the “known serious risks of myocarditis and pericarditis,” or heart inflammation and a related condition.
Regulators were also concerned about the potential risk of subclinical myocarditis, or heart inflammation without typical symptoms.
The FDA told Pfizer to carry out six studies, with various deadlines for completion and reporting final results to the agency. The first final deadline arrived on Dec. 31, 2022. Pfizer was required to submit a report on the study, which was to assess the incidence of subclinical myocarditis following administration of a third dose of Pfizer’s vaccine, or a booster shot, in people aged 16 to 30.
It’s unclear whether Pfizer met the deadline. The company and the FDA did not respond to requests for comment, and neither has issued any information about the study or its results since the deadline passed.
Judge Finds School Has Immunity in Unauthorized Vaccination of 6-Year-Old
Brattleboro Reformer reported:
A judge dealt some blows to a lawsuit seeking damages related to the vaccination of a 6-year-old for COVID-19 against his parents’ wishes at a West Brattleboro elementary school.
Last week, Judge Michael Kainen granted the state of Vermont’s motion to dismiss the suit and the Windham Southeast School District’s motion for judgment on the pleadings. The lawsuit was filed in Windham Superior Court, Civil Division by Tony and Shujen Politella of Brattleboro, the parents of the Academy School student, who are being represented by attorney Ron Ferrara of Fitts, Olson, Giddings & Ferrara in Brattleboro.
“The court found that federal law granted the district immunity based on the administration of the vaccine,” Pietro Lynn, attorney for the school district, said in an email response to the Reformer. “It is possible that other claims could be raised that fall outside the immunity grant, but those have not yet been raised.”
In a statement to the Reformer, the Vermont Attorney General’s Office said, “Under federal law, claims can only be brought based on the administration of a pandemic countermeasure if willful misconduct caused a death or serious physical injury, which did not happen here. The Court agreed with the State’s analysis of federal law and appropriately dismissed the case.”
Biden Administration Extends COVID Public Health Emergency as Highly Infectious Omicron XBB.1.5 Spreads
The Biden administration has extended the COVID-19 public health emergency until April as a highly transmissible Omicron subvariant stokes concern that the U.S. may face another wave of hospitalizations from the disease this winter.
The U.S. has renewed the COVID public health emergency every 90 days since the Trump administration first issued the declaration in January 2020.
In August, HHS told local and state health officials to start preparing for an end to the emergency in the near future. HHS has committed to giving state governments and healthcare providers 60 days’ notice before lifting the declaration.
President Joe Biden said the pandemic was over in September, a period when infections, hospitalizations and deaths were all declining. But HHS Secretary Xavier Becerra told reporters during a call in October that what the virus does this winter would determine whether or not the emergency needs to continue.
JPM23: Pfizer Entering the ‘Most Important’ 18-Month Stretch in Company History, CEO Says
Pfizer was among the drugmakers most elevated by the COVID-19 pandemic, and, going forward, the pharma giant has no plans to give up on its current momentum. Speaking this week at the J.P. Morgan Healthcare Conference in San Francisco, Pfizer CEO Albert Bourla, Ph.D., laid out scenarios that could take the drugmaker to $84 billion — or $70 billion in a less optimistic case — in non-COVID revenues in 2030.
That’d be a huge increase from 2020 when the drugmaker pulled down $41.9 billion globally. Of course, Pfizer’s trajectory changed after the company launched its massively successful COVID-19 vaccine Comirnaty and its antiviral Paxlovid.
To reach those 2030 revenue goals, the company is entering “the most important 18 months in the history of Pfizer,” Bourla said Monday. That’s because the company is planning 19 drug launches or label expansions over the next year and a half.
Those launches, in total, should generate $20 billion in sales by 2030, Bourla said. The group includes an RSV vaccine, elranatamab in multiple myeloma, ritlecitinib in alopecia areata and many other products.
MEPs Want to Grill Von Der Leyen Over Pfizer Vaccine Contract
An unwanted invite may soon be landing in Ursula von der Leyen’s mailbox. The MEPs leading the European Parliament’s COVID-19 committee have decided to ask the president of the European Commission to appear publicly in front of the panel, according to a statement sent exclusively to POLITICO by the committee’s chair, Belgian MEP Kathleen Van Brempt.
Lawmakers want to ask von der Leyen about her role in negotiating a massive, multibillion-euro coronavirus vaccine contract signed at the height of the pandemic. It was in the run-up to this contract that she is reported to have exchanged text messages with Pfizer‘s Chief Executive Albert Bourla.
“The European Union has spent a lot of public resources into the production and purchase of vaccines during the pandemic,” Van Brempt said in the statement. “[T]he Parliament has the right to obtain full transparency on the modalities of these expenditures and the preliminary negotiations leading up to them.”
So far, the Commission President has dodged questions about what went down in those crucial months. Neither the EU’s ombudsman nor the Court of Auditors has been able to shed a light on the murky dealings. The European Public Prosecutor’s Office, which is armed with legal powers that the other watchdog agencies lack, has opened an investigation into the vaccine contracts, without saying whether the Commission President is its target.
COVID Is More Widespread in Animals Than We Thought
We think of COVID-19 as a human pandemic, but it’s much more than that. The virus that causes the disease, SARS-CoV-2, can infect a wide and growing range of animals, both captive and wild.
So far, the virus has been detected in more than a hundred domestic cats and dogs, as well as captive tigers, lions, gorillas, snow leopards, otters and spotted hyenas, according to the U.S. Department of Agriculture. Zoo staff in the U.S. have recorded a single positive case in a binturong, coati, cougar, domestic ferret, fishing cat, lynx, mandrill and squirrel monkey.
In the United States, only three wild species — mink, mule deer and white-tailed deer — have tested positive, according to the USDA. Cases have been detected elsewhere in the world in wild black-tailed marmosets, big hairy armadillos and a leopard.
Another recently submitted paper also found signs of the pathogen infecting 17% of New York City sewer rats tested. And a small percentage of wild white-footed mice in Connecticut have also become infected, according to research by Rebecca Earnest, a doctoral student at Yale University.
‘A Great Day for the Country’: Uganda Declares an End to Ebola Outbreak
The Ugandan government has declared an end to its Ebola outbreak, less than four months after cases were first reported.
The country has reported no new infections in more than 42 days — twice the maximum incubation period of the virus, a World Health Organization benchmark for a country to be declared Ebola-free.
The latest outbreak of the Sudan strain of the virus was one of the worst Uganda has experienced in two decades. There is currently no vaccine against the strain.
Trials for a vaccine against the Sudan strain are underway. Government officials signaled an intention to continue to develop vaccines from the Sabin Vaccine Institute in the US, Oxford University, the Jenner Institute in the UK, the Serum Institute of India and the International Aids Vaccine Initiative.
House GOP to Embark on Sweeping Probe of COVID Origin, U.S. Response + More
House GOP to Embark on Sweeping Probe of COVID Origin, U.S. Response
House Republicans on Monday commissioned a special investigative panel focused on the coronavirus pandemic, hoping to leverage their new, powerful majority to press scientists and federal officials about the origin of the public health crisis and the government’s response to it.
Party lawmakers officially chartered the new effort in a sprawling package setting the chamber’s rules for the next two years, awarding it a sweeping mandate — from looking into vaccine development, school closures and other mitigation measures to examining the roughly $5 trillion in emergency federal aid approved since early 2020.
Rep. James Comer (R-Ky.), who is set to chair the House Oversight and Accountability Committee, under whose umbrella the COVID panel will do its work, said that congressional investigators would “talk to the researchers,” including “all of the people that were involved” at the National Institutes of Health around the development of vaccines.
In December, the congressman joined with Rep. Jim Jordan (R-Ohio), who is set to oversee other investigations of the Biden administration, to demand Anthony S. Fauci, the former head of the National Institute of Allergy and Infectious Diseases, and NIH retain records involving “the origins of COVID-19, the [Chinese government’s] efforts to cover it up and all related national security risks.”
The official charter for the 12-member subcommittee tasks it with exploring the origin of the pandemic as well as federal funding for “gain-of-function research.” The term refers to scientific efforts to create novel versions of pathogens to better understand how they work and, potentially, to combat them.
Moderna Considers Pricing COVID Vaccine at $110-$130 — WSJ
Moderna Inc. (MRNA.O) is considering pricing its COVID-19 shot at $110 to $130 per dose in the United States when it shifts from government contracting to commercial distribution of the shots, the company’s Chief Executive Officer Stephane Bancel told the Wall Street Journal on Monday.
“I would think this type of pricing is consistent with the value,” said Bancel, according to the WSJ report, adding the company was in discussions with hospital systems, pharmacies and pharmacy-benefit managers to line up distribution of its vaccine ahead of a potential fall booster shot campaign.
Moderna had previously estimated the commercial price expectations in a range of $64 to $100 a shot.
Australian Authorities to Stop Reporting Vaccination Status of Hospitalizations, Deaths
Authorities in Australia’s largest state are saying they’re going to stop reporting the vaccination status of patients hospitalized with COVID-19 after their latest report showed zero unvaccinated patients. “Vaccination status of cases admitted to hospital, admitted to ICU and those who die will no longer be reported,” the New South Wales government said in a recent overview of surveillance data from the two weeks through Dec. 31, 2022.
The report showed that of the 1,779 patients admitted to hospitals with a COVID-19 diagnosis during the two weeks, 79.5% were confirmed as receiving at least one vaccine dose and zero were confirmed as unvaccinated.
Some data and studies from elsewhere indicate that vaccines still provide some level of protection against severe illness along with virtually no shielding against infection, but others indicate that more doses increase the risk of illness.
That includes data from U.S. states that showed boosted people were more likely to get infected, hospitalized and/or die when compared to people who were vaccinated but have not received a booster, and a paper from the Cleveland Clinic that showed each successive dose heightened the chance of a person testing positive.
British Scientists Plan to Expand Genomic Sequencing From COVID to Flu
Genomic sequencing allowed the world to track new coronavirus variants throughout the pandemic. Now British researchers plan to use it to better understand a host of other respiratory pathogens, from influenza to respiratory syncytial virus (RSV).
The work is aimed at shedding more light on known threats and, potentially, emerging ones, said the team at the Wellcome Sanger Institute, working with the U.K. Health Security Agency.
“We hope that by expanding our ability to sequence these viruses routinely, we can build upon the work that’s going on COVID, and hopefully supercharge research efforts to understand the transmission of these viruses, but also to help develop new treatments and vaccines,” Ewan Harrison, head of the new Respiratory Virus and Microbiome Initiative, said.
The work will begin later this year by using leftover material from swabs taken for COVID-19 diagnostic purposes, sequencing SARS-CoV-2, influenza, RSV and other common respiratory viruses in a combined process.
Biden Team Eyes End of COVID Emergency Declaration and Shift in COVID Team
When the Biden administration renews the COVID public health emergency this week, it will mark the 11th time since the coronavirus arrived that the government declared its presence a national crisis. It may also be the last.
Senior Biden officials are targeting an end to the emergency designation for COVID as soon as the spring, after debating doing so last summer and taking a pass, three people with knowledge of the matter told POLITICO. Should they do so, such a move would represent a major pivot point in the country’s battle with the pandemic.
The decision, which has not yet been finalized amid more immediate efforts to manage a recent spike in COVID cases, would trigger a complex restructuring of major elements of the federal response — and set the stage for the eventual shifting of greater responsibility for vaccines and treatments to the private market. It would kickstart a transition away from the White House-led crisis operation and toward treating the virus as a continuous long-term threat.
Under the current tentative plan, health officials will quietly renew the emergency declaration for another 90 days before its scheduled expiration on Wednesday. That would give the administration until early February to alert states and health industry representatives that it plans to end the designation.
Moderna CEO Says COVID Moving Into Endemic Stage
Moderna CEO Stephane Bancel said coronavirus is transitioning from a pandemic to an endemic. “It’s tough to look precisely because none of us managed a transition from a pandemic to an endemic before. But we really think now that we’re moving into an endemic setting,” he told FOX Business’ Maria Bartiromo in an exclusive interview that aired on “Mornings with Maria” Tuesday.
Bancel went on to say the Omicron booster resulted in “very good” clinical data in terms of vaccine efficacy. “I think we are now getting ready for yet another update in the fall, and we are going to move most probably to annual boosters for people at high risk.”
In 2022, Moderna generated a whopping $18.4 billion, but now analysts are lowering estimates for 2023 to a mere $5 billion. Bancel said that the projected $5 billion is a “flaw” in terms of sales and that the company sees that as a bare “minimum.”
“But $5 billion, we see it as a flaw, meaning those are things where we already have contracts placed like with Canada and the U.K. This $5 billion assumes no sales in the U.S. And of course, we are currently talking to pharmacies and hospital network and doctors to have the new boosters available in the fall of 23′. So, I think that this is what we see as a minimum, as a flaw in terms of sales,” the CEO explained.
COVID Vaccines: From Nasal Drops to a Redesign, What 2023 Could Have in Store
Several vaccine companies say they are expecting breakthroughs as early as this year as they pursue new ways to protect people against SARS-CoV-2, the virus that causes COVID-19.
The Food and Drug Administration is set to convene a panel of its outside vaccine advisers later this month to weigh key issues over the future of COVID-19 vaccines, including when and how to greenlight new boosters and changes to which strain the vaccines target.
Several companies have been pursuing approaches that could offer better protection against infections themselves, instead of merely blunting the severity of the disease. Potential vaccines to build this kind of “mucosal immunity” aim to bring antibodies to fend off the virus at the sites where it first enters the body, through vaccines that could be taken through drops, sprays or pills.
Novavax and Moderna, as well as Pfizer and BioNTech, say they are pursuing clinical trials of versions of their COVID-19 vaccines blended with components designed to trigger immunity against influenza or RSV in a single shot.
WHO Meeting to Decide on COVID Emergency Set for Jan. 27
A World Health Organization committee will meet on Jan. 27 to consider whether the COVID-19 pandemic still represents a global emergency, a spokesperson said on Tuesday, three years after it was first declared.
WHO spokesperson Carla Drysdale confirmed the timing of the meeting at a Geneva press briefing. The Emergency Committee advises WHO Director General Tedros Adhanom Ghebreyesus who makes the ultimate call on whether an outbreak represents a so-called Public Health Emergency of International Concern which is the U.N. agency’s highest level of alert.
Several leading scientists and WHO advisers say it may be too early to declare the end of the COVID-19 pandemic emergency phase because of high levels of infections in China which dismantled its zero-COVID policy last month.
Pfizer CEO Rules Out Generic COVID Drug Paxlovid for China
Pfizer Inc. (PFE.N) is not in talks with Chinese authorities to license a generic version of its COVID-19 treatment Paxlovid for use there, but is in discussions about a price for the branded product, Chief Executive Albert Bourla said on Monday.
Reuters reported on Friday that China was in talks with Pfizer to secure a license that will allow domestic drugmakers to manufacture and distribute a generic version of the U.S. firm’s COVID-19 antiviral drug Paxlovid in China.
Referring to that report, Bourla, speaking at J.P. Morgan’s healthcare conference in San Francisco, said “We are not in discussions. We have an agreement already for local manufacturing of Paxlovid in China. So we have a local partner that will make Paxlovid for us, and then we will sell it to the Chinese market.”
‘My Body Was Burning’: Suffering Since COVID Shots, Canadian Man Desperate for Relief + More
‘My Body Was Burning’: Suffering Since COVID Shots, Gatineau Man Desperate for Relief
A Gatineau, Que., man who developed a severe skin condition after receiving a COVID-19 vaccine says he’s ready to give up on Canada’s healthcare system and seek treatment abroad.
Mohammed Tisir Otahbachi, 29, received his first dose of the Moderna vaccine on July 15, 2021, at a Walmart pharmacy in Gatineau. Ten days later, small acne-like blisters appeared on his right hand. Otahbachi, who goes by his middle name, told CBC he had never experienced any kind of skin problem before. He tried a topical cream suggested by a pharmacist, but it didn’t work.
While serious complications from COVID-19 vaccines are rare, Otahbachi had a sneaking suspicion his shot might have had something to do with the rash. Nevertheless, he was eager to receive his second dose and returned to the same pharmacy for another Moderna jab on Aug. 13, 2021. “Two days after that, like 48 hours later, almost the whole of my body — my hands, arms, my legs, even my back — it was [hit with] the same thing, and it started burning a little bit. There was some pain,” Otahbachi recalled. “I recognized there is something happening on my body because of the vaccine.”
“I couldn’t work because my body was burning. I was not able to touch anything, even the water,” said Otahbachi, who was reduced to washing with baby wipes. Throughout his ordeal, Otahbachi noticed something else: none of the doctors he had consulted appeared willing to acknowledge any possible link between his vaccination the previous summer and the sudden onset of his skin condition.
Moderna Meets Forecast With $18.4 Billion in COVID Vaccine Sales in 2022
Moderna Inc. (MRNA.O) said on Monday it generated about $18.4 billion in COVID-19 vaccine sales in 2022, meeting its forecast of $18 billion-$19 billion for the year.
The company also forecast minimum COVID-19 vaccine sales of about $5 billion in 2023, compared with its previous forecast of $4.5 billion to $5.5 billion in November.
The COVID vaccine maker continues to expect additional contracts for 2023, it said.
Breaking: Researcher Claims mRNA COVID Vaccines Can Increase Serious Adverse Events; Calls for It to Be Withdrawn From the Market
Joseph Fraiman, an emergency physician and a clinical scientist from Louisiana, claims that the messenger RNA COVID-19 vaccine can increase serious adverse events in people, including sudden cardiac deaths.
In a video that surfaced online, Fraiman, who was a lead author of the peer-reviewed research that re-analyzed Pfizer & Moderna trials for mRNA COVID-19 vaccine, says, “We found the vaccine increases serious adverse events at a rate of one in 800. At the time of the publication, my co-authors and I did not believe our single study warranted the withdrawal of mRNA vaccines from the market. However, since its publication, new pieces of evidence have come to light and this has caused me to reevaluate my position.”
Referring to another study and drawing similarities with his own research, he shares, “An article published in the BMJ regarding the FDA’s own observational surveillance data from messenger RNA was associated with multiple of the exact same serious adverse events identified in our original study.” However, the researcher adds the FDA has failed to inform the public of these findings.
“Together this information calls into question if the vaccine’s benefits outweigh the harm. I believe the mRNA vaccines need to be withdrawn from the market until new randomized control trials can clearly demonstrate the benefits of the vaccine outweigh the serious harm we now know vaccines are causing,” he adds.
Omicron XBB.1.5 Is Rising in U.S. Though Revised CDC Data Shows Slower Increase Than Previously Reported
The Centers for Disease Control and Prevention on Friday revised downward its estimate of how much the Omicron XBB.1.5 subvariant is circulating across the U.S., though it continues to spread at a faster pace than other versions of COVID-19.
XBB.1.5 made up 27.6% of sequenced COVID cases nationally for the week ending Jan. 7 compared with 18.3% for the week ending Dec. 31. The CDC previously reported that XBB.1.5 made up about 41% of sequenced cases for the week ending Dec. 31, more than any other variant.
Although the agency has revised its estimate downward, XBB.1.5 remains the only Omicron subvariant showing significant growth in the U.S. right now. It is second only to Omicron BQ.1.1, which currently makes up 34% of sequenced COVID cases in the U.S.
XBB.1.5 makes up more than 70% of sequenced cases in the northeastern U.S., which is often a bellwether for the rest of the country. Scientists at Columbia University, in a recent study, noted that variants in the XBB family pose a serious threat to the Omicron boosters.
AstraZeneca’s Preventative COVID Treatment Likely Not Effective Against XBB.1.5: FDA
The Food and Drug Administration (FDA) said on Friday that AstraZeneca’s preventative monoclonal antibody treatment for COVID-19 is likely ineffective against the XBB.1.5 Omicron subvariant due to its similarity to other mutations of the virus that are also not neutralized by the treatment.
In a statement, the FDA said it “does not anticipate that Evusheld will neutralize XBB.1.5.”
Evusheld is a combination of two monoclonal antibodies that has been authorized as pre-exposure prophylaxis to prevent COVID-19 infections in those who are moderately to severely immunocompromised.
The FDA advised healthcare providers to inform their patients of the increased risk of COVID-19 infection due to variants that are not neutralized by Evusheld.
Ocugen-Bharat Biotech COVID Vaccine Meets Main Goals in U.S. Trial
Ocugen Inc. (OCGN.O) said on Monday the COVID-19 vaccine developed by its Indian partner Bharat Biotech International Ltd. met the main goals of a trial in the United States.
The vaccine, sold under the brand name Covaxin, showed an immune response in individuals who had not received a COVID vaccine previously as well as those vaccinated with mRNA vaccines by Pfizer Inc. (PFE.N) and Moderna Inc. (MRNA.O), meeting its main goals, Ocugen said.
Covaxin is not cleared for use in any age group in the United States, but is one of the two most widely used COVID vaccines in India and has received an emergency use listing from the World Health Organization (WHO).
China’s COVID Wave Threatens Another Snarl of U.S. Medical Supply Chain
As COVID infections surge across China, the U.S. again risks falling short of medical supplies as that country struggles to keep factories running and goods flowing out of its ports.
U.S. hospitals, healthcare companies and federal officials worked to lessen their dependence on China for medical goods after the first wave of COVID infections in 2020 laid bare the major role China plays in manufacturing such crucial items as masks, latex gloves and surgical gowns, along with the key drugs and components in many medical devices.
Healthcare executives and supply chain analysts warn the impact of China’s latest COVID wave could take months to work its way through the supply chain and much will depend on the trajectory of the pandemic in the coming weeks, something officials in the U.S. have limited insight into given the lack of data from China.
The U.S. imported $3.2 billion in drugs and active pharmaceutical ingredients directly from China in 2020, including antibiotics, antidepressants, birth control pills and drugs for chemotherapy, according to a 2021 supply chain analysis by the White House.
Omicron COVID Booster Cuts Hospitalization in Over 65s, Israeli Study Finds
The Omicron-adapted COVID-19 vaccine booster developed by Pfizer Inc. (PFE.N) and BioNTech SE (22UAy.DE) sharply reduced hospitalizations among older patients, Israeli researchers said on Monday, in some of the first evidence of the jab’s real-world effectiveness.
The study by researchers from healthcare provider Clalit, Ben-Gurion University of the Negev and Sapir College has not yet been peer-reviewed.
It found an 81% reduction in hospitalizations among people aged 65 and older who had received the booster against those who had previously received at least two COVID vaccinations, but not the Omicron-adapted shot.
While the bivalent vaccine targets the original strain and its BA.4/BA.5 Omicron subvariant, scientists have been closely watching another Omicron subvariant, XBB.1.5, which has been rapidly spreading in the United States.
Chinese-Made mRNA Vaccine Starts Trial Production
China’s CanSino Biologics Inc (6185.HK) has entered the “test production phase” for its COVID-19 mRNA booster vaccine, the company said in a post on its social media account late on Thursday.
The vaccine, known as CS-2034, targets new Omicron variants of the virus, which are responsible for the vast majority of infections that have swept across China since the country began dismantling strict COVID curbs last month.
Until now, China has relied on nine domestically-developed COVID vaccines approved for use, including inactivated vaccines, but none have been adapted to target the highly-transmissible Omicron variant and its offshoots that are currently in circulation.
The CanSino booster vaccine is one of China’s first home-grown potential vaccines based on mRNA technology similar to that employed in vaccines produced internationally by Pfizer-BioNTech and Moderna.
First Vaccine for Honeybees Approved
The United States Department of Agriculture (USDA) approved its first-ever vaccine for honeybees. The vaccine, developed by Dalan Animal Health, Inc., aims to protect the species from American Foulbrood disease Paenibacillus larvae.
Bees play a crucial role in agriculture thanks to their important work as crop pollinators. The FDA estimates bee pollination accounts for around $15 billion in added crop value.
The company plans to administer the vaccine on a limited basis to commercial beekeepers and hopes to make it available for purchase in the United States this year.
The approval follows positive results of a randomized clinical trial published in Oct. 2022, which showed the vaccine protects against American Foulbrood through a process called transgenerational immune priming. In this process, maternal organisms transfer pathogen immunity to the next generation.
FDA Approves 2nd Alzheimer’s Drug, Despite Safety Concerns
U.S. News & World Report reported:
The U.S. Food and Drug Administration on Friday approved a second Alzheimer’s drug, lecanemab, despite reports of rare brain bleeds linked to the use of the drug in some patients.
Lecanemab, made by Eisai and marketed by Biogen as Leqembi, will be only the second Alzheimer’s drug to receive the FDA’s blessing in the past 18 months; the agency’s speedy approval of the drug Aduhelm in June 2021 generated controversy in the medical community over its lack of effectiveness, brain bleed concerns and hefty price tag.
But Alzheimer’s experts said the story is somewhat different with Leqembi. “Unlike Aduhelm, which had an incomplete data set and where clinical trial data failed to demonstrate a definitive slowing in cognitive decline, lecanemab showed a statistically significant slowing in cognitive and functional decline, as well as reduction of brain amyloid levels, and downstream beneficial effects on other markers of neurodegeneration,” Dr. Sarah Kremen, who leads the Alzheimer’s Disease Clinical Trials Program at Cedars-Sinai in Los Angeles, said in a statement.
Leqembi has been linked to two deaths from brain bleeds among people who used it in trials.
Cancer Vaccine Trials — Using Same mRNA Tech Behind COVID Shots — Could Launch in U.K. This September + More
Cancer Vaccine Trials — Using Same mRNA Tech Behind COVID Shots — Could Launch in U.K. This September
Trials of cutting-edge cancer vaccines could kick off in the U.K. as soon as September, German COVID vaccine maker BioNTech announced on Friday, part of a new government partnership to fast-track development of the same mRNA technology behind the most successful coronavirus vaccines as companies race to build upon pandemic successes and target other diseases.
As many as 10,000 cancer patients in the U.K. will be treated with personalized mRNA cancer treatments by 2030, BioNTech said in a statement, whether as part of a clinical trial testing the new therapies or as approved treatment.
Such treatments are often described as cancer vaccines because they work by training the patient’s immune system to target and attack cancer cells, the same mechanism the vaccines produced by Pfizer, BioNTech and Moderna use to train the body to recognize and fight the virus causing COVID-19.
BioNTech said it will also set up a regional headquarters in London and a scientific research hub in Cambridge.
Biden Has Called for Annual COVID Booster Shots. But Is That Realistic?
U.S. News & World Report reported:
“For most Americans, one COVID shot each year will be all they need,” President Joe Biden said at the White House. “And if you get it, you’ll be protected. And if you don’t, you’re putting yourself and other people at unnecessary risk.”
He has also spread the idea on Twitter, saying: “Our nation’s experts say that most folks will only need one updated COVID vaccine to stay protected all year long. One shot, once a year. Just like flu.”
But more than three months after the Biden administration first floated the idea of an annual COVID-19 booster shot, no official policy has been announced as questions and hurdles remain.
These questions are exactly what a committee of vaccine experts will be discussing at an upcoming Food and Drug Administration meeting in late January. Among other things, they will talk about “how and whether the composition and schedule for booster doses should be adjusted moving forward.”
Stanford Medicine Scientists Pinpoint COVID Virus’s Entry and Exit Ports Inside Our Noses
Stanford Medicine News reported:
If only there were a “morning after” nasal spray that could knock out respiratory viruses’ ability to colonize your nose and throat. In a study in the print issue of Cell, Peter Jackson, Ph.D., a Stanford Medicine professor of pathology and of microbiology and immunology, and his colleagues brought that possibility closer to reality by pinpointing the routes that SARS-CoV-2, the COVID-19 virus, take to enter and exit cells in our nasal cavity. “Our upper airways are the launchpad not only for infection of our lungs but for transmission to others,” Jackson said.
Jackson shares senior authorship of the study — the first to describe COVID-19 nasal infection in molecular detail — with Raul Andino, Ph.D., professor of microbiology and immunology at UC San Francisco. The lead authors are former Stanford Medicine postdoctoral scholar Chien-ting Wu, Ph.D., and graduate student Ran Cheng, along with UCSF postdoctoral scholars Peter Lidsky, Ph.D., and Yinghong Xiao, Ph.D.
The findings identify new targets for a nasally applied drug that, by impeding ciliary motion or microvilli gigantism, could prevent even unknown respiratory viruses — the kind you meet, say, at a pandemic — from making themselves at home in your nose or throat.
Jackson said substances used in these experiments could perhaps be optimized for use in, say, nasal sprays soon after a respiratory viral exposure, or as prophylactics.
Omicron Subvariant XBB.1.5 Accounts for 27.6% of U.S. COVID Cases — CDC
The Omicron subvariant, XBB.1.5, is estimated to account for 27.6% of COVID-19 cases in the United States for the week ending Jan. 7, data from the Centers for Disease Control and Prevention showed on Friday.
The CDC revised its estimate for the week ended Dec. 31 to say XBB.1.5 made up 18.3% of cases, not about 40% of cases. The agency did not immediately respond to a Reuters request seeking details about the change in estimated data.
The World Health Organization’s senior epidemiologist, Maria Van Kerkhove, earlier this week said XBB.1.5 is the most transmissible Omicron sub-variant that has been detected so far.
Biden Administration Launches Pilot Program for COVID Telehealthcare
The National Institutes of Health (NIH) on Thursday announced the launch of a pilot program that will allow people to receive free testing, consultation and treatment for COVID-19 from their homes.
The NIH estimated up to 8,000 eligible individuals will participate in the pilot program, called the Home Test to Treat program, which will be led by local and state officials in Berks County, Pennsylvania.
Major pharmacy chains including CVS and Walgreens already offer telehealth services that can help facilitate treatments for COVID-19, and some primary care physicians also provide this option for their patients. Walgreens partnered with companies including DoorDash and Uber to offer free deliveries of COVID-19 antivirals last year.
Judge: Tennessee Must Release Consultant COVID Response Docs
A Tennessee judge has ordered Gov. Bill Lee’s administration to release consultant reports that recommend how to respond to the COVID-19 pandemic — documents the state argued should remain secret under public records law.
The series of records requests, some dating back to 2020, resulted in denials and later releases of certain documents. Ultimately, the state withheld six documents and redacted parts of others, claiming they fell under a “deliberative process” privilege. The lawsuit was filed in January 2022.
“While we continue to believe that the common law deliberative process privilege should not be recognized by courts in Tennessee, we are pleased with the Court’s finding that the McKinsey records would not be covered by such a privilege and must be disclosed,” McAdoo said. “The release of this information is important to providing Tennesseans with a more complete understanding of the state’s response to the COVID-19 pandemic.”
The documents that the state refused to produce include one identifying key strategic issues to be addressed; two “scenario planning” documents; an “economic scenario planning” document; a file about issues and strategies for institutions under the Tennessee Higher Education Commission; and a document outlining “potential bold moves to combat COVID-19,” the judge wrote.
Here’s What People With Long COVID Need to Know About Navigating Health Insurance
Navigating the health insurance system is often difficult and overwhelming, even in the best of times. For patients with long COVID, a relatively new condition that frequently leaves patients with a lengthy and unpredictable list of debilitating symptoms, it can be especially nightmarish.
Nearly half of people with long COVID reported increased medical expenses, according to a recent survey conducted by the Patient Advocate Foundation. The nonprofit, NPAF’s sister organization, polled 64 people with the condition between 2020 and 2022. Meanwhile, 13% of respondents in the PAF survey said they’d experienced changes to their healthcare coverage as a result of long COVID.
In all, one Harvard University researcher estimated that long COVID could leave patients with an extra $9,000 a year in medical expenses. Between 2 million and 4 million full-time workers are out of the labor force due to long COVID, according to recent research from the Brookings Institution.
The Kraken COVID Variant Is Coming — but Not yet
The EU’s disease control agency has good news and bad news when it comes to XBB.1.5, the coronavirus sub-variant nicknamed Kraken that is ripping through America and keeping epidemiologists up at night.
The bad news is that XBB.1.5 is spreading quickly, most likely because it has some big advantages over the currently dominant Omicron strains. The good news is that Europe has some time to prepare for if and when cases go vertical.
“There is a possibility that this variant could have an increasing effect on the number of COVID-19 cases in the EU/EEA, but not within the coming month as the variant is currently only present in the EU/EEA at very low levels,” writes the European Centre for Disease Prevention and Control (ECDC) in its recent assessment of XBB.1.5.
For now, the sub-variant is just a blip on the radar in Europe in terms of case numbers, said the ECDC, though it has been detected in Denmark, France, Austria, the Netherlands, Germany, Italy, Spain, Sweden, Iceland, Belgium, Czech Republic, Portugal and Ireland. Data coming out of the U.S. suggests XBB.1.5 spreads aggressively, with cases doubling every nine days.
Exclusive: China in Talks With Pfizer for Generic COVID Drug
China is in talks with Pfizer Inc. (PFE.N) to secure a license that will allow domestic drugmakers to manufacture and distribute a generic version of the U.S. firm’s COVID-19 antiviral drug Paxlovid in China, three sources told Reuters.
China is in talks with Pfizer Inc. (PFE.N) to secure a license that will allow domestic drugmakers to manufacture and distribute a generic version of the U.S. firm’s COVID-19 antiviral drug Paxlovid in China, three sources told Reuters.
In February last year, China approved Paxlovid, which was supposed to be largely available via hospitals, to treat high-risk patients in several provinces. Pfizer last month reached an agreement to export Paxlovid to China through a local company to make the medicine more widely available.
A Pfizer spokesperson said the company is actively collaborating with Chinese authorities and all stakeholders to secure an adequate supply of Paxlovid in China.
Moderna Signs $35 Million Deal With Cancer Drug Developer CytomX
Moderna Inc. (MRNA.O) on Thursday announced a $35 million licensing deal with cancer-focused drug developer CytomX Therapeutics (CTMX.O) to work on messenger RNA-based therapies for a wide range of diseases.
Shares of California-based CytomX rose more than 50% in extended trading. The firm will get $5 million in prepaid research funding as part of the upfront payment and it is eligible for up to about $1.2 billion in future milestone payments, the companies said in a joint statement.
The news comes a month after an experimental cancer vaccine from Moderna based on mRNA technology was shown to work against a type of skin cancer.
The deal offers CytomX access to Moderna’s mRNA technology, which has been used to develop COVID-19 vaccines, while Moderna would get access to CytomX’s Probody platform, used in the development of cancer therapies targeting diseased tissues.
Canadians’ Concern Over COVID Has Waned — and so Has Their Drive to Get Vaccinated: Poll
A majority of Canadians remain concerned about COVID-19, however, their anxieties toward the virus have softened and vary depending on age, according to a new poll. The Ipsos poll conducted exclusively for Global News between Dec. 14 and 16, 2022, found 61% of the 1,004 adults surveyed indicated that COVID-19 is a concern and 70% disagreed with the notion the virus “is not a big deal.”
However, a clear consensus that once existed among Canadians supporting strong public health measures and showing high levels of concern appears to have softened, says Ipsos senior vice-president Sean Simpson.
As concern over SARS-CoV-2 is waning in Canada, so, too, is Canadians’ drive to get COVID-19 vaccines, according to the poll. Fifty-eight percent of respondents said they had recently received a COVID-19 vaccine and another 14% said they intended to get one. But close to three in 10 said they do not intend to get a COVID-19 shot, which represents a reduction in the proportion of people who say they’re going to get the vaccine, Simpson said.
