The Latest: FDA considers boosters of Moderna, J&J vaccines

NEW YORK — Many Americans who got Pfizer vaccinations are rolling up their sleeves for a booster shot. Meanwhile, millions who received the Moderna or Johnson & Johnson vaccine wait to learn when it’s their turn.

Federal regulators begin tackling that question this week. On Thursday and Friday, the Food and Drug Administration convenes its independent advisers for the first stage in the process of deciding whether extra shots of the two vaccines should be dispensed and, if so, who should get them and when.

The final go-ahead is not expected for at least another week. After the FDA advisers give their recommendation, the agency will make an official decision on whether to authorize boosters. Then a panel convened by the Centers for Disease Control and Prevention will offer more specifics on who should get them.

The FDA meetings come as U.S. vaccinations have climbed back above 1 million per day on average, an increase of more than 50% over the past two weeks. The rise has been driven mainly by Pfizer boosters and employer vaccine mandates.

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MORE ON THE PANDEMIC:

— Russia registers another record in daily deaths at 973

— Report says UK’s slow virus lockdown cost thousands of lives

— California coronavirus death count tops 70,000 as cases fall

— Merck asks FDA to authorize promising COVID-19 pill

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See all of AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic

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HERE’S WHAT ELSE IS HAPPENING:

LONDON — The German biotechnology company CureVac says it has withdrawn its application for the approval of its coronavirus vaccine from the European Medicines Agency and will focus on making next-generation messenger RNA vaccines.

In a statement on Tuesday, CureVac says recent communications with the EU drug regulator suggested its COVID-19 vaccine might only be authorized in mid-2022. Earlier this year, the company described its initial vaccine results as “sobering,” after data suggested the shot was only about 47% effective.

CureVac says it will instead prioritize the development of second-generation mRNA vaccines with its partner GlaxoSmithKline and expects to be in “late-stage clinical development” by the middle of next year.

The EMA confirmed Tuesday it had ended the accelerated evaluation of the CureVac vaccine, a process started in February. COVAX, the U.N.-backed effort to share vaccines globally, had been waiting for possible doses from CureVac, which received funding from one of the COVAX partners.

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MOSCOW — Russia has registered another record number of daily coronavirus deaths as it faces a rapid surge of contagion amid low vaccination rates.

The government coronavirus task force reported 973 coronavirus deaths Tuesday, the highest daily toll since the start of the pandemic. The country has continuously registered new coronavirus death records this month. Daily infections also have been hovering near all-time highs, with 28,190 new confirmed cases Tuesday.

Despite the rapidly mounting coronavirus caseload and deaths, the Kremlin has ruled out a nationwide lockdown, delegating the power to make decisions on tougher coronavirus restrictions to regional authorities.

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ISLAMABAD — Pakistani authorities on Tuesday reported less than 700 coronavirus cases for the first time since June amid a steady decline in the infections from coronavirus.

There were 689 confirmed cases and 18 deaths reported in the past 24 hours, according to the country’s National Command and Operation Center.

The latest development comes weeks after Pakistan said unvaccinated people won’t be allowed to work in offices, enter shopping malls or attend schools. It forced many people to get vaccinated to avoid punitive measures. The country is offering free shots to teens and adults.

Pakistan has reported 1.2 million confirmed cases and 28,152 confirmed deaths since the start of the pandemic.

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LONDON — The British government’s failure to impose a lockdown in the early days of the COVID-19 pandemic ranks among England’s worst public health errors, lawmakers concluded Tuesday in the country’s first comprehensive report on the pandemic.

The deadly delay led to thousands of unnecessary deaths and derived from the failure of government ministers to question the recommendations of scientific advisers, resulting in a dangerous level of “groupthink” that caused them to dismiss the more aggressive strategies adopted in East and Southeast Asia, the report said.

It was only when Britain’s National Health Service risked being overwhelmed by rapidly rising infections that Prime Minister Boris Johnson’s Conservative government finally ordered a lockdown in late March 2020.

“Accountability in a democracy depends on elected decision-makers not just taking advice, but examining, questioning and challenging it before making their own decisions,” the committees said. “Although it was a rapidly changing situation, given the large number of deaths predicted, it was surprising the initially fatalistic assumptions about the impossibility of suppressing the virus were not challenged until it became clear the NHS would be overwhelmed.”

Cabinet minister Stephen Barclay defended the government’s response. He says, “decisions were taken on the evidence and the scientific advice at the time.”

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UNITED NATIONS — The United Nations chief says the pandemic has forced more than 100 million people into poverty and left some 4 billion people with little or no social support, health care or income protection.

Secretary-General Antonio Guterres told an International Monetary Fund panel Monday that global solidarity “is missing in action” and people living in conflict-affected and poor countries are suffering the most.

Guterres said: “Vaccine inequality is a moral outrage that is condemning the world to millions more deaths and prolonging an economic slowdown that could cost trillions of dollars, hitting the poorest countries hardest of all.”

Guterres says indications the world is in a substantial economic recovery mask the huge divergence between the situations in rich countries and in the least developed nations.

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RALEIGH, N.C. — North Carolina officials say nearly all of the 10,000 employees working in 14 state-operated health care facilities are fully vaccinated against the coronavirus.

Officials said Monday that 6% of the workers got an approved medical or religious exemption or a special accommodation, while the remaining 94% are fully vaccinated.

Three-fourths of the workers had been vaccinated when the state health department announced the vaccine mandate in July. The remaining workers and those with just one of the two shots had until the end September to become fully vaccinated or secure an approved exemption.

The state says just 16 workers, or less than 0.2% of the total workforce, were fired for their refusal to comply with the directive.

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SEATTLE — Amazon says it will allow many tech and corporate workers to continue working remotely indefinitely as long as they can commute to the office when necessary.

The new policy was announced in a blog post. It’s a change from Amazon’s previous expectation that most employees would need to be in the office at least three days a week after offices reopen from the COVID-19 pandemic in January.

Most of Amazon’s more than 1 million employees worldwide cannot work remotely because they are in the company’s fulfillment and transportation division.

About 50,000 tech and office employees in Seattle work at the company’s headquarters campus. Their absence will hurt nearby businesses.

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SACRAMENTO, Calif. — California’s coronavirus death toll has reached 70,000 people.

The state is emerging from the latest infection surge with the lowest rate of new cases among all states. Last year at this time, cases in the state started ticking up and by January California was in the throes of the worst spike of the pandemic. Daily deaths approached 700.

The latest surge started in summer and was driven by the delta variant that primarily targeted the unvaccinated. At its worst during this spike, California’s average daily death count was in the low hundreds.

Data collected by Johns Hopkins University showed the state with 70,132 deaths by midday Monday. It’s the most in the nation, surpassing Texas by about 3,000 and Florida by 13,000.

California’s per capita fatality rate of 177 per 100,000 people ranks in the bottom third for the U.S.

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GENEVA — An expert group advising the World Health Organization on vaccines has recommended that older people and those with compromised immune systems get an extra dose of COVID-19 vaccine as part of their regular schedule, in line with what many rich countries including Britain, France and the U.S. have already recommended for their populations.

At a press briefing on Monday, the WHO’s vaccines director, Dr. Kate O’Brien, said the group was advising that people who have weaker immune systems “should receive an additional dose” of all of the WHO-approved vaccines beyond the normally recommended two doses, to produce an immune response to protect them from severe disease, hospitalization and death.

O’Brien said this third dose should be given to people sometime between one to three months after the second dose and was not considered a booster.

She emphasized that this recommendation does not apply to healthy, younger adults who have a normal immune response to vaccination and have no underlying conditions. The WHO’s expert group recommended that people get the same vaccine they received for their original immunization where possible.

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SEATTLE — Most of Washington’s health care workers have been fully vaccinated against the coronavirus, with a week left before the state’s immunization deadline.

As of Monday morning, 88% of health care workers had showed proof of vaccination, the Washington State Hospital Association reported. The results include data from 94% of the state’s hospitals, collected after Oct. 4.

The Seattle Times reports the remaining 12% of workers include those who are partially vaccinated, have an approved exemption and accommodation, have applied or plan to apply for an exemption that hasn’t yet been reviewed, have not yet provided vaccination verification, or are choosing not to be vaccinated.

The hospital association said it believes 2% to 5% of hospital staff could leave the workforce because of the mandate.

All health care workers must be fully vaccinated by Oct. 18 or face “nondisciplinary dismissal” for failure to meet job requirements, Gov. Jay Inslee announced in August. Final vaccination numbers won’t be available until early November, the hospital association said.

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WAUKESHA, Wis. — A parent has sued a southeastern Wisconsin school district after her son contracted COVID-19 from a classmate.

The Milwaukee Journal Sentinel reported that Shannon Jensen filed the lawsuit in federal court against the Waukesha School District and school board on Oct. 5. Jensen is seeking an injunction ordering the district to comply with U.S. Centers for Disease Control COVID-19 guidelines.

According to the lawsuit, the board in May removed a student mask requirement and other COVID-19 mitigation measures. One of Jensen’s son’s classmates came to school with symptoms in September and didn’t wear a mask. Jensen’s son was seated next to the sick student and was wearing a mask but still became infected. Jensen’s other two sons later tested positive as well.

School Board President Joseph Como declined comment on the lawsuit.

The Minocqua Brewing Company Super PAC is funding the lawsuit. The brewing company is owned by Kirk Bangstad, who has aired his frustrations about how former President Donald Trump’s administration responded to the pandemic. He ran unsuccessfully against incumbent Republican state Rep. Rob Swearingen last year.

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Categories: AP National News