Broad U.S. Booster Plan Rejected; Testing at Apple: Virus Update

(Bloomberg) —

A U.S. Food and Drug Administration panel of expert advisers voted against a third dose of the Pfizer Inc.-BioNTech SE vaccine for everyone 16 and older but appeared willing to consider a booster shot for a limited population of older adults and other vulnerable populations.

The average daily death toll from Covid-19 in the U.S. has risen above 2,000, increasing almost ninefold in less than three months as the delta wave extends into autumn. 

Apple Inc. will begin mandating frequent testing for U.S. employees who aren’t vaccinated, while letting inoculated workers get checked less often. 

The U.K. government eased testing requirements for fully vaccinated people arriving in England, removing a significant barrier to travel and boosting airlines and tourism firms.

Key Developments:

Global Virus Tracker: Cases pass 227.3 million; deaths exceed 4.6 millionVaccine Tracker: More than 5.85 billion doses administeredAlpine party town where Covid raged sparks court fightHow the pandemic left British households $1.2 trillion richerHow small-business owners can prepare for the next pandemicCan your boss force you back to the London office?: Q&A

FDA Panel Rejects Broad Booster Plan (3:40 p.m. NY)

A U.S. Food and Drug Administration panel of expert advisers voted against a third dose of the Pfizer Inc.-BioNTech SE vaccine for everyone 16 and older but appeared willing to consider a booster shot for a limited population of older adults and other vulnerable populations.

The FDA had asked the advisory panel to vote on whether the safety and effectiveness data submitted by the companies support approval of a booster dose for people age 16 and up. Panelists are discussing narrower options after rejecting that proposal in a 16-2 vote. 

Some of the panelists indicated that while they see a potential need for older or other more vulnerable groups to receive a third dose, the need for younger people could be less pressing, and may pose other medical risks.

“There are very clear populations where a booster may be appropriate, such as elderly or immunocompromised,” said National Institutes of Health scientist Michael Kurilla. “It’s not clear to me that the data we’re seeing right now is applicable or necessary for the general population.”

Apple Mandates Frequent Tests for Unvaccinated (2:40 p.m. NY)

Apple Inc. will begin mandating frequent testing for U.S. employees who aren’t vaccinated, while letting inoculated workers get checked less often. 

The push, which begins next month, will apply to U.S. offices and stores, the company told employees at a meeting Friday. Apple said it’s assessing its policies on a country-by-country basis, but Chief Executive Officer Tim Cookurged workers to get the vaccine. The iPhone maker has gradually tightened Covid policies, while still stopping short of requiring all employees to get the shots.

Pfizer Protection Wanes Faster: Study (1:17 p.m. NY) 

Pfizer Inc.’s vaccine declined in protection against hospitalization after four months, while Moderna Inc.’s remained stable, U.S. researchers found in an analysis of data from 21 US hospitals across 18 states.

Two doses of either vaccine provided more protection against hospitalization than the one-dose Johnson & Johnson vaccine, the study found, though Pfizer’s advantage over J&J narrowed over time, according to the study published Friday by the Centers for Disease Control and Prevention with collaborators across the country. All three vaccines provided substantial protection after four months — Moderna’s was 92% effective against hospitalization by then, with Pfizer’s at 77% and J&J at 68%.

France Hits Vaccine Target Later Than Hoped (12:57 p.m. NY)

France has given the first dose of the vaccine against Covid-19 to 50 million people, President Emmanuel Macron said in a Twitter post on Friday. The country initially aimed to reach this milestone at the end of August.

Belgium Agrees to Mixed Covid Rules (12:40 p.m. NY)

Belgium’s regional governments agreed to divergent virus rules starting next month. An obligation to wear masks in bars, restaurants and stores will be abolished in Flanders, the wealthier Dutch-speaking region in the north, while the Brussels capital region and southern Wallonia will keep it mandatory. The Brussels government is also working on the use of a proof of vaccination, recovery or negative test to gain access to certain venues. In Belgium’s capital, only 51% of the population is fully vaccinated. Flanders has a vaccination rate of 78%, Wallonia is at 67%.

U.K. to Simplify International Travel (12:02 p.m. NY)

The U.K. government eased coronavirus testing requirements for fully vaccinated people arriving in England, removing a significant barrier to travel and boosting airlines and tourism firms.

Those who’ve had two shots will be exempt from a pre-departure test before flying from nations that aren’t high risk, while screening after arrival will be downgraded to quicker and cheaper lateral-flow tests, the Department for Transport said Friday.

A so-called traffic-light system used to categorize countries will also be replaced, with a single “red list” for locations where infection rates are high and “simplified measures for the rest of the world,” Transport Secretary Grant Shapps said in a message on Twitter.

Israelis Uncertain Over Booster Longevity (11:54 a.m. NY)

Researchers from Israel told a panel of U.S. vaccine experts weighing a potential Covid-19 booster dose from Pfizer Inc. and BioNTech SE that it’s unclear how long the benefit of such a shot would last.

A big part of the case for booster shots is data from Israel showing that, in the short term, a third dose of the vaccine dramatically lowered infections and severe illness in the short term in people over age 60 and older. 

However, it isn’t yet clear whether the enhanced protection boosters could provide would be short-lived, or if the benefit would be lasting.

Colorado Hospitals Under Strain (11:35 a.m. NY)

Regional hospital capacity in Colorado Springs, Colorado, is shrinking as Covid-19 admissions rise to the highest this year, the Colorado Springs Gazette reported. David Steinbruner, chief medical officer at hospital chain UCHealth, said: “This is extremely worrisome, considering we are also about to enter flu season.” The state recently activated a Combined Hospital Transfer Center to help rural and metropolitan hospitals place patients, the newspaper said.

Fight at NYC Restaurant Over Vaccine Proof (11 a.m. NY)

Three women visiting from Texas beat up an employee of the popular restaurant Carmine’s in New York City on Thursday night after she asked them for a vaccine card, a police spokeswoman said. 

Earlier this week, city restaurants were required to enforce a rule that diners indoors must show proof of having received at least one dose of vaccine. At Carmine’s, the request escalated into a “verbal dispute,” then blows to the server that caused redness, bruising and a broken necklace, the spokeswoman said. 

The women, from the Houston area, were charged with assault. 

U.S. Average Daily Deaths Rise Above 2,000 (10:49 a.m. NY)

The average daily death toll from Covid-19 in the U.S. has increased almost ninefold in less than three months as the delta wave extends into autumn. 

The seven-day average of fatalities reached 2,203 on Thursday, the highest level since February and up from 251 on July 1, according to data compiled by Johns Hopkins University and Bloomberg. More than 670,000 Americans have succumbed to the virus so far, a little more than half of them last year. 

© Bloomberg More than 2,000 Americans are dying of Covid a day, on average

On the inoculation front, vaccinations have slipped recently and the U.S. has given out enough shots to cover about 60% of its population, according to the Bloomberg vaccine tracker. Confirmed infections are still averaging more than 150,000 a day. If current trends hold 2020’s death toll will be surpassed in 2021 — a time when vaccines became widely available in the nation. 

WHO Urges Vaccine Equity at UN (10:43 a.m. NY)

The World Health Organization urged leaders attending the United Nations General Assembly to guarantee access to Covid vaccines and other life-saving tools.

In a press release issued on Friday, WHO said its targets of vaccinating 40% of every country’s population by the end of 2021, as well as 70% by mid-2022, was achievable with “genuine commitment” from countries and manufacturers.

Additionally, the agency called on world leaders to ensure the world is better prepared for future pandemics, highlighting a need to break from the “cycle of ‘panic and neglect’ seen after previous health emergencies.” 

Swiss Tighten Rules for Unvaccinated Travelers (9:05 a.m. NY)

Switzerland is toughening the rules for unvaccinated travelers after returning holidaymakers over the summer drove a rise in infections. 

Those who aren’t inoculated or haven’t recovered from the virus will need to present a negative test upon arrival as of Sept. 20, the government said. They will then need to get another test after four to seven days. 

Third Shots Introduced for Vulnerable Finns (7:52 a.m. NY)

Finland decided to start giving third vaccinations to severely immunocompromised people with immediate effect, and said plans were being drawn up for giving third jabs to those treating Covid patients, elderly people resident in care homes and their carers.

EU Upholds Recommendation on Astra 2nd Dose (6:47 a.m. NY)

European Medicines Agency’s human medicines committee says there’s no evidence that delaying a second dose of AstraZeneca’s vaccine Vaxzevria has any influence on the risk of TTS. EMA maintains recommendation to continue giving a second dose of Vaxzevria within 4 to 12 weeks of the first, in line with product information.

HIV Link to Child Deaths in South Africa (5:37 p.m. HK)

South Africa should consider vaccinating adolescents after data showed that the most common underlying cause of death among infected youngsters during the ongoing third wave was HIV infection. “Given the high prevalence of HIV among adolescents in South Africa, efforts should be considered to vaccinate” those with underlying conditions that put them at increased risk of severe Covid-19, the country’s National Institute for Communicable Diseases said in a report this week. Giving shots to those between 15 and 18-years-old “may need to be prioritized to close the immunity gap,” the NICD said.


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