Moderna Booster Backed by U.S. Panel; Biden’s Plea: Virus Update

(Bloomberg) -- Booster shots of Moderna Inc.’s vaccine should be given to older people and those at high risk of the disease, a U.S. Food and Drug Administration advisory panel said.  

Another FDA panel will take up Merck & Co.’s emergency use authorization request for its Covid-19 pill on Nov. 30, taking the data into a public forum to discuss any safety concerns.

President Joe Biden called on more businesses to require employee vaccinations, which have mostly survived a first wave of legal challenges. 

United Airlines Holdings Inc. is planning its largest expansion into Europe, anticipating that next summer will deliver record traffic. 

Key Developments:

• Virus Tracker: Cases top 239.4 million; deaths exceed 4.8 million
• Vaccine Tracker: More than 6.6 billion shots given
• Long Covid doubles burden of mystery illness few doctors treat
• Supremacy of Pfizer-BioNTech’s vaccine underlined by new data
• Ivermectin is unproven for Covid, but drugmakers are cashing in
• Manhattan rents rise for the first time since Covid’s early days

California Deaths Surpass 70,0000 (4:35 p.m. NY)

California added 148 deaths for a total of 70,010, making up one in 10 fatalities in the country.

About one in nine people in the state have had Covid-19, though the number of new hospitalizations, cases and deaths have declined since the start of September.

The Golden State is also outperforming other states in the handling of the pandemic, with a seven-day average of 11.8 cases for every 100,000 among the lowest in the nation.

Colorado Health Workers Not Getting Vaccinated (4:27 p.m. NY)

In Colorado, fewer than 60% of health care facilities are even partially in compliance with the state’s vaccine mandate, the Denver Gazette reported. Despite pleas from health organizations, state officials said they will not loosen an inoculation requirement set to soon to go into effect, the newspaper reported.

The Gazette also reported almost 3,000 Colorado K-12 students have been infected in recent outbreaks, an increase of more than a third since Sept. 29.

FDA Panel Backs Moderna Boosters (3:18 p.m. NY)

Booster shots of Moderna Inc.’s Covid-19 vaccine should be given to older people and those at high risk of the disease, advisers to U.S. regulators said. 

The additional doses should be offered to people aged 65 and older along with those between 18 and 64 years old who are at high risk for medical or occupational reasons, the Food and Drug Administration advisory panel said Thursday in a unanimous, 19-0 vote. The shots should be given six months after the initial inoculation, the panel said. 

The vote follows a similar recommendation from the panel on a booster from Pfizer Inc. and BioNTech SE.

U.S. Ups Vaccine Donation to Africa (3:15 p.m. NY)

President Joe Biden will announce the donation of an additional 17 million doses of Johnson & Johnson’s vaccine to the African Union after the U.S. faced criticism it hasn’t been more generous.

Biden is expected to make the announcement at a meeting Thursday with Kenyan President Uhuru Kenyatta at the White House, according to a senior administration official who requested anonymity ahead of the event. Delivery of the single-dose J&J shot is expected in the coming weeks.

Verizon Mandates Shots for Non-Union Workers (3:01 p.m. NY)

Non-union Verizon employees in the U.S. must be fully vaccinated by Dec. 8, Verizon says in a statement posted on its website.

Employees must provide proof they are fully vaccinated “regardless of where they work or how often they come into a Verizon work location.” The company said the requirement doesn’t apply to union-represented workers as it’s still in talks with the unions.

Vaccine Capacity Isn’t Main Bottleneck, IMF Says (1:51 p.m. NY)

The world has enough production capacity to deliver both initial Covid-19 vaccinations and booster shots, International Monetary Fund Managing Director Kristalina Georgieva said. An IMF analysis concludes that the biggest obstacle is vaccine delivery, Georgieva said during a virtual panel discussion.

What’s needed are transparent contracts and delivery schedules as well as health systems that can deliver inoculations quickly, Georgieva said. The IMF sees a roughly $20 billion aid gap for the “last mile” of vaccine distribution, she said.  

Biden Calls on Businesses to ‘Step Up’ (1:41 p.m. NY) 

President Joe Biden said the number of unvaccinated Americans remains too high and called on more businesses to impose vaccination mandates. 

“Every day, we see more businesses implementing vaccination requirements and the mounting data shows that they work,” Biden said Thursday at the White House. “I’m calling on more businesses to step up.” 

Merck Pill to Be Reviewed Next Month (1:15 p.m. NY)

The U.S. Food and Drug Administration will send Merck & Co.’s Covid-19 pill to an advisory committee for review at a meeting on Nov. 30.

The FDA announcement is expected imminently, and means the agency opted not to skip the advisory committee step, which it occasionally does when it’s racing to get a drug to market quickly. Safety concerns have been raised by some experts, and the committee will weigh in before the FDA makes a decision, the person said. 

NYC Teachers’ Challenge Questioned by Judge (12:38 p.m. NY)

A federal appeals court expressed skepticism of a bid by four New York City public school employees to halt the city’s Covid vaccination mandate, as a three-judge panel questioned a lawyer for the workers.

Circuit Judge Susan Carney balked at the attorney’s argument that teachers are a constitutionally protected class and that the vaccine requirement infringes on a fundamental right. 

“I’m having difficulty seeing why this is an irrational policy decision of the city,” she said of the mandate in a hearing Thursday in Manhattan.

Shot Mandates Endure Court Challenges (11:50 a.m. NY)

U.S. workplace vaccination mandates have largely survived a first wave of legal challenges even as the number of lawsuits over them has soared with their expanded use.

Workers and advocacy groups have filed at least 39 federal cases this year, contesting vaccination requirements imposed by employers or governments, with 85% of them arriving after Aug. 1, according to a Bloomberg Law review. Courts have denied requests for temporary orders against mandates in 12 of the suits, while seven have ended with dismissals.

“What we’ve seen so far in the courts really demonstrates how durable and well judicially supported vaccine mandates are,” said Lawrence Gostin, director of Georgetown University’s O’Neill Institute for National and Global Health Law.

Sputnik Light Works Better With mRNA Dose (11:55 a.m. NY)

The single-shot Sputnik Light vaccine provides stronger immune response when given along with shots from Moderna and Astra Zeneca than a second dose of those inoculations, according to Argentine Health Ministry data released by Sputnik partner the Russian Direct Investment Fund. The trial involving 1,000 people also showed positive results for Sputnik when used with the Cansino and Sinopharm vaccines, RDIF said. On Wednesday, RDIF reported Sputnik Light showed 70% effectiveness against the delta variant, according to a preprint study that hasn’t yet been subjected to peer review.

NYC Delta Wave Waning (10:51 a.m. NY) 

New York City hit six million New Yorkers who have got at least one shot of the Covid-19 vaccine, Mayor Bill de Blasio said during Thursday briefing. Over 84% of adults have at least the first shot, with 75% of teenagers, de Blasio said. There’s only about a million adults left in the city to be vaccinated, he said.

Meanwhile, cases, hospitalizations and deaths are dropping from the delta variant-fueled summer peak: The seven-day average of total hospitalizations fell to 30 on Sunday, down from 119 in August, according to city data. The average weekly hospitalization rate for unvaccinated people is 22 per 100,000 residents, compared to two per 100,000 residents among vaccinated people, according to city data collected since vaccines were introduced in New York in January.

United Bets Big on European Vacations (8:32 a.m. NY)

United Airlines Holdings Inc. is planning its largest expansion into Europe, anticipating a surge of pent-up demand following two years of weak bookings because of the pandemic. Among the new routes, United is adding five destinations starting in May and June that are not currently served by North American carriers: Amman, Jordan; Bergen, Norway; Azores, Portugal; Palma de Mallorca, Spain and Tenerife in the Canary Islands.

Italy Prepares for New Rules (8:16 a.m. NY)

Italy’s public and private sector workers will be required to show proof of either vaccination or a negative test not older than 48-hours upon entering their workplace as of Friday. The country has one of the world’s highest inoculation rates, with around 80% of the population fully vaccinated. 

Still, the decision by Prime Minister Mario Draghi has stoked tensions and protests that turned violent in Rome last weekend. Further demonstrations are expected in the coming days, with particular strain likely to be seen at ports, where there’s a higher than average rate of non-vaccinated workers. 

In Trieste harbor -- Europe’s seventh-biggest port, where about 40% of workers aren’t vaccinated -- some unions are threatening to block the facilities until the government revokes the measure.

Romania Runs Out of ICU Beds (8:07 a.m. NY)

Romania, the European Union country with the second-lowest vaccination rate, ran out of intensive-care beds, according to the government. More than 3,000 Covid deaths in the past two weeks have pushed the toll to more than 40,000.  

More than 16,000 new cases were rerpoted in the past 24 hours, close to a daily record. Hospitals are overwhelmed with severely-ill patients and authorities are considering transferring some abroad. 

Russia Has New Daily Record (5:55 p.m. HK)

Russia reported new daily records, with 31,299 infections in the past day and 986 deaths. The Federal Statistics Service said deaths since summer have been running at their highest level for the pandemic. With only about a third of Russians vaccinated, many regions are returning to social restrictions to try to curb the spread of the virus.

African Infections Undetected (4:31 p.m. HK)

Six out of seven Covid-19 infections go undetected in Africa, showing that the impact of the disease on the world’s least vaccinated continent is likely underestimated, according to the World Health Organization. Africa has seen 8.4 million cases to date, or 3.5% of the global total, even though the continent accounts for about a sixth of the world’s population. 

The WHO will later on Thursday announce a plan to step up testing in Africa.

Ireland Reopening in Doubt (3:16 p.m. HK)

After topping Bloomberg’s Covid resilience rankings last month, concerns over escalating cases are putting Ireland’s next phase of reopening in question.

While almost 89% of people over the age of 12 are fully vaccinated, hospitalizations are now at the highest since March. Prime Minister Micheal Martin said he couldn’t currently “guarantee” that the final unwinding of restrictions scheduled for Oct. 22 would go ahead as planned, though no “decisions have been made.”

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