Novavax awaits FDA decision on whether its next COVID shot can be offered in US

 Novavax will only be able to offer a COVID-19 vaccine in the United States this autumn if regulators accept the shot it has started manufacturing that targets a variant that was dominant earlier this year, the company said.

Novavax's updated vaccine targets a variant called JN.1, which is in line with European recommendations. The European Union's regulator told vaccine makers last month to update their vaccines for that variant because they would likely be effective against its descendant lineages.

The U.S. Food and Drug Administration has not yet made a decision on the makeup of the next round of COVID vaccines and a JN.1 subvariant known as KP.2 has become dominant in the United States over the past month.

Novavax's traditional, protein-based vaccine is developed in moth cells and takes months to manufacture. In 2023, for instance, Novavax said it needed six months to bring an adequate supply of vaccine to the market.

Vaccines based on messenger RNA (mRNA), like those from Moderna or Pfizer and partner BioNTech, can be developed more quickly. In the past, Pfizer has said it could make the shots in 100 days.

Moderna and Pfizer each told Reuters they are waiting for the FDA's advisers to discuss vaccine design at a June 5 meeting before settling on which variant their next vaccines will target.

Novavax disclosed on its earnings call earlier this month that it had already advanced a version of its vaccine targeting JN.1 into commercial development.

"If a strain other than JN.1 is selected this late in the development process, a protein-based option will not be available for the U.S. population," Novavax said in a statement emailed to Reuters this week. Novavax makes the only protein-based COVID vaccine for the U.S.

The Maryland-based company said in the statement it has data showing good cross-reactivity between its vaccine and the currently dominant KP.2 variant.

Novavax recently struck a licensing deal worth at least $1.2 billion with Sanofi for its COVID vaccine, bolstering a company that had lost most of its value since the pandemic.

It was only able to take a low-single-digit percentage market share in the U.S. during the 2023-2024 vaccination campaign as demand for COVID vaccines was smaller than hoped and the company got its shot to market later than rivals.

In 2024, the company expects revenue in the range of $400 million to $600 million, down significantly from last year, when it recorded $983.7 million in revenue.

Since 2022, regulators have asked vaccine makers to design new versions of the COVID shots to better target currently circulating variants.

Last year, both the U.S. and Europe settled on the same targets for their vaccine designs. In 2022, the European Medicines Agency (EMA) initially endorsed vaccines targeting a different variant than the ones authorized in the U.S.

The FDA recently postponed its vaccine advisory meeting from May 16 in order to have more time to "obtain surveillance data and other information" on the circulating virus.

The FDA did not immediately comment on its plans.

"Our hope is that the (FDA vaccine advisory committee) discussion and recommendation consider the public health benefit of chasing newer variants as well as the role of diverse vaccine options in supporting vaccine uptake," Novavax said.

https://www.yahoo.com/news/novavax-awaits-fda-decision-whether-201925046.html

Mayo Clinic must face religious bias claims over COVID vaccine policy, court rules

  A U.S. appeals court on Friday revived a lawsuit accusing the Mayo Clinic in Minnesota of illegally firing five employees who refused on religious grounds to receive the COVID-19 vaccine or be regularly tested for the virus.

A unanimous three-judge panel of the St. Louis-based 8th U.S. Circuit Court of Appeals , opens new tab the judge who tossed out the consolidated lawsuits last year wrongly ruled that the workers had not connected their objections to Mayo's COVID-19 policies with sincere Christian religious beliefs.

Three of the workers were fired for refusing the vaccine and two others who received religious exemptions were terminated for declining weekly COVID-19 testing.

They claimed that their refusal stemmed from the belief that their bodies are temples and from their objections to the use of fetal cells in the production of vaccines.

"The district court erred by emphasizing that many Christians elect to receive the vaccine," U.S. Circuit Judge Duane Benton wrote. "Beliefs do not have to be uniform across all members of a religion or acceptable, logical, consistent, or comprehensible to others."

The opinion by Benton, an appointee of Republican former President George W. Bush, was joined by U.S. Circuit Judges Ralph Erickson and Jonathan Kobes, appointees of Republican former President Donald Trump.

The Mayo Clinic and lawyers for the plaintiffs did not immediately respond to requests for comment.

Like many employers, particularly in the healthcare industry, Mayo in 2021 adopted a policy requiring all employees to be vaccinated against COVID-19. Workers who received exemptions were required to take weekly COVID-19 tests.

The plaintiffs - two nurses, a paramedic, a CT technician and the supervisor of a bacteriology lab - all sought religious exemptions. Three were denied and two were approved, but those workers declined to undergo testing, saying they believed it was unnecessary and violated the sanctity of their bodies.

The workers were fired and in 2022 filed separate lawsuits in Minneapolis federal court accusing Mayo of religious discrimination in violation of Title VII of the Civil Rights Act of 1964 and a Minnesota anti-discrimination law.

U.S. District Judge John Tunheim, an appointee of Democratic former President Bill Clinton, opens new tabin August 2023.

He said the plaintiffs had only broadly stated their religious beliefs and had not shown that vaccines and testing violated them. The plaintiffs appealed.

The Equal Employment Opportunity Commission, which enforces Title VII, filed a friend-of-the-court brief urging the 8th Circuit to revive claims by two of the workers, Kenneth Ringhofer and Shelly Kiel.

Tunheim applied too high of a bar in finding that the plaintiffs' refusal of the vaccine was more personal or political than religious.

"There may sometimes be overlap between a religious and political view, but that does not necessarily place the belief outside the scope of Title VII’s religion protections," the commission said.

The 8th Circuit on Friday agreed with respect to all five plaintiffs.

"The district court did not consider the complaints as a whole, instead focusing on specific parts of the complaints to rule the anti-vaccine beliefs 'personal' or 'medical," Benton wrote.

The case is Ringhofer v. Mayo Clinic Ambulance, 8th U.S. Circuit Court of Appeals, No. 23-2994.

For the plaintiffs: Gregory Erickson of Mohrman, Kaardal & Erickson

For Mayo: Holly Robbins of Littler Mendelson

For the EEOC: James Driscoll-MacEachron

https://www.reuters.com/legal/government/mayo-clinic-must-face-religious-bias-claims-over-covid-vaccine-policy-court-2024-05-24/

Bird flu detected in tissue samples of US dairy cow sent to slaughter, USDA says

 Bird flu virus particles were found in tissue samples taken from one dairy cow sent to slaughter at a U.S. meat processing plant, but none were detected in samples from 95 other cattle, the U.S. Department of Agriculture (USDA) said on Friday.

Meat from the animals was prevented from entering the nation's food supply, USDA said.

Agriculture and health officials have scaled up testing of meat and dairy products and livestock, as an outbreak of bird flu has expanded in dairy cattle.

Two U.S. dairy workers have tested positive for bird flu since the virus was first detected in cattle in late March.

Older dairy cows are often processed for hamburger meat. USDA's testing results come at the start of peak U.S. grilling season around the U.S. Memorial Day weekend.

To date, USDA said it has completed testing on beef tissue from 96 of 109 muscle samples that were collected as part of a meat safety study.

The agency said it collected tissue samples at slaughter facilities from dairy cattle that were condemned for systemic diseases and then analyzed them using PCR testing. The testing does not differentiate between live virus or fragments, USDA said.

The U.S. Food and Drug Administration previously said it found viral particles in pasteurized milk samples from retail stores, but they did not contain live virus. The FDA has warned against consuming raw unpasteurized milk.

USDA personnel identified signs of illness in the positive cow during a routine post-mortem inspection and prevented its meat from entering the food supply, according to USDA.

"These actions provide further confidence that the food safety system we have in place is working," the agency said.

USDA has confirmed bird flu in 58 dairy herds across nine states.

It previously reported that no viral particles were found in samples of ground beef collected at retail stores, and that no bird flu virus was found after cooking ground beef to medium to well done, after it was injected with a virus surrogate as part of an experiment.

https://www.yahoo.com/news/bird-flu-detected-tissue-samples-182143772.html

US safety probe into Waymo self-driving vehicles finds more incidents

 The National Highway Traffic Safety Administration said Friday it has learned of nine additional incidents that raise concerns about the performance of Alphabet's Waymo self-driving vehicles.

Earlier this month, the U.S. auto safety regulator opened an investigation after 22 reports of its robotaxis exhibiting driving behavior that potentially violated traffic safety laws, or demonstrating other "unexpected behavior," including 17 collisions.

In a letter to Waymo released Friday, NHTSA said it has learned of 9 additional similar incidents.

The agency said several incidents under investigation "involved collisions with clearly visible objects that a competent driver would be expected to avoid."

NHTSA said "reports include collisions with stationary and semi-stationary objects such as gates and chains, collisions

with parked vehicles, and instances in which the (automated driving system) appeared to disobey traffic safety control

devices or rules."

The agency asked Waymo to answer a series of questions by June 11 about the incidents and provide video for all of the incidents.

Waymo, which did not immediately comment Friday, earlier this month did not address specific safety incidents cited by NHTSA but said it was "proud of our performance and safety record over tens of millions of autonomous miles driven."

NHTSA said it is concerned that Waymo self-driving vehicles "exhibiting such unexpected driving behaviors may increase the risk of crash, property damage, and injury" and added that a number of incidents occurred "in the proximity of other road users, including pedestrians."

The investigation is the first stage before the agency could demand a recall if it believes the vehicles pose an unreasonable risk to safety.

This is the latest in a series of investigations opened by NHTSA into the performance of self-driving vehicles after it initiated probes into General Motors Cruise and Amazon.com's Zoox < AMZN.O>.

In February, Waymo recalled 444 self-driving vehicles after two minor collisions in quick succession in Arizona, saying a software error could result in automated vehicles inaccurately predicting the movement of a towed vehicle.

https://finance.yahoo.com/news/us-safety-probe-waymo-self-132742980.html

Airlines, hotels, retailers fear being left out in Google's search changes

 Lobbying groups representing airlines, hotels and retailers have urged European Union tech regulators to ensure that Google takes their views into account, and not just large intermediaries, when making changes to comply with landmark tech rules.

Airlines for Europe group that has Air France KLM and British Airways owner IAG> as members, hotel group Hotrec, European Hotel Forum, EuroCommerce, Ecommerce Europe and Independent Retail Europe had in March expressed their concerns about the impact of the new rules.

EU's Digital Markets Act (DMA) imposes a list of dos and don'ts on Google and five other tech giants aimed at giving users more choice and rivals a better chance to compete, but the groups voiced concerns the the adjustments could hurt their revenues.

In a joint letter to EU antitrust chief Margrethe Vestager and EU industry chief Thierry Breton dated May 22 they said their worries have mounted since then.

"Our industries have serious concerns that currently considered solutions and requirements for implementing the DMA could further increase discrimination," they wrote.

"Initial observations indicate that these changes risk severely depleting direct sales revenues of companies by giving more prominence to powerful online intermediaries due to the preferential treatment they would receive," they said.

The Commission, which is now investigating Google for possible DMA breaches, did not immediately respond to a request for comment.

Google, which in a March blog post said changes to search results give large intermediaries and aggregators more traffic and less for hotels, airlines, merchants and restaurants, had no immediate comment.

"We are concerned that the non-compliance investigation refers only to the need to treat third-party services in a fair and non-discriminatory manner, without any acknowledgement of European businesses that also offer their services on Google," the groups said.

https://finance.yahoo.com/news/airlines-hotels-retailers-fear-being-174748292.html

Three Christian missionaries from Oklahoma-based group killed in Haiti

 Three Christian missionaries from Missions in Haiti were shot and killed in an ambush by a gang in Haiti, the Oklahoma-based group said on Friday.

The missionaries were taking shelter in a house when gang members began shooting at the residence at about 9 p.m. CDT (0200 GMT) Thursday, the group said in two Facebook posts.

Months of gang violence in Haiti have forced the government into retreat, and U.S. Secretary of State Antony Blinken has warned the country is close to becoming a failed state.

Haiti’s main international airport in Port-au-Prince reopened this week, nearly three months after it shut due to deadly gang-related violence. But gangs still control much of the capital and Haiti's main seaport remains closed.

A spokesperson for the White House National Security Council said the Biden administration was aware of reports of the deaths of U.S. citizens and offered condolences.

"Our hearts go out to the families of those killed as they experience unimaginable grief," the spokesperson said.

Missouri State Representative Ben Baker said his daughter Natalie Lloyd and son-in-law Davy Lloyd were killed while working as full-time missionaries. Davy Lloyd was the son of the organization's founders, David and Alicia Lloyd, who started it in 2000.

The identity of the third person killed has not been released.

"My heart is broken in a thousand pieces. I’ve never felt this kind of pain," Baker said on Facebook.

Missions in Haiti said the couple was leaving a church when they were ambushed by three trucks full of gang members. They took Davy Lloyd to a house, tied him up and beat him, before taking the group's trucks and some items and left, it said.

"Another gang came after to see what was going on and if they could help, so they say," the organization said. "No one understood what they were doing, not sure what took place but one was shot and killed and now this gang went into full attack mode."

The couple and another individual identified as Jude called a leader of the organization on a satellite phone and said that their lives were in danger.

https://www.yahoo.com/news/three-missionaries-oklahoma-based-group-154613139.html

'UCLA police make first arrest in mob attack on pro-Palestinian encampment'

 Three weeks after a mob attacked pro-Palestinian activists encamped at the University of California, Los Angeles, police have made their first arrest in the violence, a man they say was seen in video footage beating victims with a wooden pole.

The suspect, identified as Edan On, 18, was taken into custody on Thursday in the city of Beverly Hills and booked on suspicion of assault with a deadly weapon, the UCLA Police Department said in a statement on Friday.

The man, who police said had no affiliation with UCLA, was reported by local media to be a Beverly Hills High School student.

His arrest was the first by police in their investigation of the violence that flared on campus between pro-Palestinian activists occupying a tent camp to protest Israel's war in Gaza, and a group who attacked them late on the night of April 30.

The masked assailants, described by university officials and police as "instigators," stormed the protest site with clubs and poles, sparking a pitched skirmish in which both sides traded blows and doused each other with pepper spray. The encampment occupants said fireworks were also hurled at them.

University officials and police came under harsh criticism from California Governor Gavin Newsom and others for how they responded to the confrontation, which continued for at least three hours into the early morning of May 1 before police moved in and restored order.

https://www.yahoo.com/news/ucla-police-first-arrest-mob-205127079.html