Covid-19 Live: Pfizer Updates, Vaccine Mandates and Latest News – The New York Times

ImageMedical personnel briefing people waiting for Covid vaccination last month outside Gqeberha, South Africa.
Credit…Jerome Delay/Associated Press

JOHANNESBURG — Moderna said on Thursday that it planned to build a vaccine manufacturing facility in Africa, news that was welcomed for the long-term but that does not address the continent’s immediate need for Covid-19 vaccines.

The company said that a new “state of the art” facility would eventually produce up to 500 million doses a year of Moderna’s mRNA vaccine, which has shown an efficacy rate of more than 90 percent in preventing Covid-19. The plant will, in time, also produce other Moderna vaccines, the company said.

Building vaccine manufacturing sites in Africa will increase the continent’s future access to the drugs. But it does not answer calls from African leaders and activists to waive patent laws that would give more drugmakers access to details on how coronavirus vaccines are produced. It also does not address the continent’s immediate Covid-19 vaccine shortages.

“It doesn’t necessarily solve our problems today,” Dr. John Nkengasong, the director of the Africa Centers for Disease Control and Prevention, said in a regular news briefing on Thursday. “The problems we have are quick access to vaccines, redistribution of vaccines, making sure that certain licenses are provided so that manufacturing can start regionally.”

The drug makers Pfizer and BioNTech said in July that they had partnered with Biovac, a public-private partnership pharmaceutical company in Cape Town. In Gqeberha, the South African coastal city formerly known as Port Elizabeth, Johnson & Johnson has partnered with Aspen, a local manufacturer, in a fill-and-finish manufacturing process.

Moderna said that it expected to invest up to $500 million in its future site, and that its facility would manufacture the doses with fill-and-finish capacity, in addition to packaging facilities.

It said it would now begin the process of identifying which country would host the plant.

“While we are still working to increase capacity in our current network to deliver vaccines for the ongoing pandemic in 2022, we believe it is important to invest in the future,” said Stephane Bancel, Moderna’s chief executive.

African leaders had already established the Partnerships for African Vaccine Manufacturing, which works within an existing “ecosystem” of Africa’s vaccine needs. Launched in April, it has political backing from the continent’s leaders, including Presidents Cyril Ramaphosa of South Africa and Paul Kagame of Rwanda.

Ten countries have already expressed interest in developing and upscaling their manufacturing capacity through the partnership, Dr. Nkengasong said.

“We can bring them all together and put Moderna at the center,” he said, “and that will really speak to the need to be transparent but also to be cooperative and to coordinate on efforts.”

Moderna’s announcement comes amid mounting pressure on biotech firms to share their expertise with manufacturers in countries that desperately need more coronavirus vaccine doses.

Moderna, an American drug company, developed its coronavirus vaccine with billions of dollars in taxpayer money. The Massachusetts-headquartered company also received initial research and development funding from Covax, the vaccine sharing facility supported by the global vaccine alliance Gavi and the World Health Organization.

Moderna also signed a purchase agreement with Covax in May that has delivered over eight million doses to African countries, according to a Gavi spokesman. Nigeria, Africa’s most populous country, has received nearly half of the consignment of the double-shot vaccine, and Ghana, Kenya and Tunisia have each received over a million doses.

Credit…Allison Zaucha for The New York Times

With deadlines for health care workers to take coronavirus vaccinations either passed or quickly approaching, only a fraction of those workers across the United States are risking their jobs by not complying.

The consequences that employers warned of are becoming reality.

UCHealth System in Colorado fired 119 people this week. Kaiser Permanente, based in California, has suspended more than 2,200 employees. And 400 workers have resigned from the Henry Ford Health System in Detroit rather than get inoculated.

On Friday, UCHealth, a nonprofit system serving the Rocky Mountain region, sent the last of several email reminders to the 119 employees — 0.5 percent of its work force — who had not received a vaccination or a medical or religious exemption. They had already been removed from weekend schedules and were notified this week of their termination.

“Certainly we would have liked 100 percent compliance,” Dan Weaver, the vice president of communications, said in an interview on Wednesday. He said that the terminated employees had been “encouraged” to reapply for their positions if they got vaccinated.

Kaiser Permanente, one of the nation’s largest nonprofit health plans, announced its vaccination requirement on Aug. 2, when 78 percent of its work force had already been inoculated. A spokesman said this week that the level had risen to more than 92 percent.

Still, about 1 percent of Kaiser’s work force across the country — approximately 2,200 workers — were put on unpaid administrative leave because they had not met the requirement, the spokesman said. They have until Dec. 1 to get vaccinated to be able to return to work.

The Henry Ford Health System required its employees to comply with a vaccination requirement by last Friday. The system said on Tuesday that 99 percent of its 33,000 employees had been fully vaccinated, were soon to get their second dose or had received medical or religious exemptions.

About 400 employees have resigned over the requirement, but new hires have already made up for the loss, officials said.

At Henry Ford, Bob Riney, the chief operating officer and president of health care operations, said that people who had left the company could reapply once they were inoculated.

“We are doing all we can to keep those doors open,” Mr. Riney told reporters. “Whatever their choice, we wish them the very best and appreciate the years of service they provided our community and organization.”

Northwell Health, New York State’s largest health care provider, said on Monday that 1,400 employees — less than 2 percent of its staff — had declined to get vaccinated against the coronavirus and had to leave their jobs.

President Biden announced a mandate on Sept. 9 that requires workers at nearly every hospital and health system in the country to get vaccinated or be tested weekly for the coronavirus.

Credit…Brendan Mcdermid/Reuters

Countries in the Asia-Pacific region this week became some of the first after the United States to secure supplies of molnupiravir, the pill that the pharmaceutical company Merck says could halve the risk of hospitalization and death from Covid-19.

Merck said in June that the United States had agreed to buy enough pills for 1.7 million treatments, at a cost of $1.2 billion. This week, Australia, Malaysia, Singapore and South Korea said that they had reached agreements with the drug maker to buy the pills, even though their regulatory agencies have yet to approve the drug. Thailand and Taiwan are also in talks with Merck to buy them, Reuters reported.

While many nations in Asia had a slow start at vaccinating against Covid-19, countries including Malaysia, Singapore and South Korea have now administered more vaccine doses than the United States per capita. Merck’s treatment, the first oral antiviral drug that can be taken at home, is expected to help limit the impact of future outbreaks and reduce the need for costly hospital treatment.

A patient would take four capsules twice a day for five days, or 40 pills total.

Prime Minister Scott Morrison of Australia said on Tuesday that his government had agreed to buy 300,000 courses, pending regulatory authorization, which could happen in early 2022.

“Vaccines and new treatments like this will boost our national plan to safely reopen Australia and keep Australia safely open,” he said in a statement.

Malaysia has struck a deal to secure 150,000 treatments, its health minister, Khairy Jamaluddin, said on Thursday. “This complements our successful vaccination rollout,” he said in a tweet, adding that the ministry would continue to buy more treatment options.

South Korea secured enough pills for more than 20,000 treatments and is continuing talks with the company to secure more, the office of Prime Minister Kim Boo-kyum said on Wednesday. The government has budgeted to buy 38,000 doses of the drug in total this year and next year, it said in a statement.

Singapore also secured a deal to purchase the drug, Merck said in a statement on Wednesday, according to Reuters. The health ministry confirmed the deal to Reuters but did not disclose the number of pills citing commercial sensitivities.

Merck did not immediately respond to an early morning request for comment by telephone and email.

Merck has said it plans to seek emergency authorization for the pills to be used in the United States. Initially, the drug might be available only for people considered high risk, such as older people or those with comorbidities, though experts say that the pills could eventually become more widely available.

White House officials have said that people should get vaccinated even if Merck’s pill cuts deaths. Vaccination “remains far and away our best tool against Covid-19,” said Jeff Zients, the White House coronavirus adviser.

Credit…Doug Mills/The New York Times

President Biden is traveling to Chicago on Thursday to talk about vaccine mandates.

Chicago was picked in part because it is the home of United Airlines, one of the first major carriers to require shots for its 67,000 U.S. employees. Other airlines have followed with similar requirements, including American Airlines, Southwest, JetBlue and Alaska Airlines.

Jeff Zients, the White House coronavirus response coordinator, announced the trip on Wednesday and said that Mr. Biden would focus on the success of vaccine mandates.

Mr. Biden said last month that he would use his presidential powers to require two-thirds of American workers be vaccinated against the coronavirus. That included a private sector to mandate that all companies with more than 100 workers require vaccination or weekly testing.

He also moved to mandate shots for health care workers, federal contractors and most federal workers, who could face disciplinary measures if they decline to be inoculated.

Mr. Biden will talk about the impact that those requirements are having, Mr. Zients said.

“We believe that vaccination requirements at workplaces are very effective and an efficient way to ensure people are vaccinated or tested,” Mr. Zients said.

United Airlines has said that it would terminate about 600 employees for not complying with its vaccination requirement. About 99 percent of its U.S. work force has been vaccinated, according to the airline.

Credit…Jon Chol Jin/Associated Press

The World Health Organization said on Thursday that it had resumed shipments of medical supplies to North Korea to help its Covid-19 response, in what appears to signal a relaxation of the closed-border policies enforced by Pyongyang early in the pandemic.

The agency said that its shipments of medical supplies, together with international supplies destined for North Korea, had become stranded in China after Pyongyang sealed the country’s borders in January 2020 when Covid-19 was declared a public health emergency of international concern.

North Korea’s Ministry of Public Health told the agency several months ago that would allow the stranded supplies to be transported through the northern Chinese port of Dalian, a W.H.O. spokesman, Tarik Jasarevic, said in an emailed statement.

As a result, the agency had sent some of the medical supplies and equipment to the North Korean port of Nampo, he said.

North Korea has not reported any Covid-19 infections, and it turned down several offers of vaccines, including ones from the United Nations-backed Covax facility and from Russia. But North Korea’s leader, Kim Jong-un, said in June that lapses in his country’s anti-pandemic campaign had caused a “great crisis” that threatened “grave consequences,” according to the state media. He did not clarify whether he was referring to an outbreak within the country.

The W.H.O. said its shipments to North Korea included health kits, medicines and other medical supplies that would support essential health services at primary health care centers.

The agency said it had been told that these supplies remained under quarantine in Nampo.

Credit…Shawn Rocco/Duke Health, via Reuters

WASHINGTON — Pfizer and BioNTech said on Thursday morning that they had asked federal regulators to authorize emergency use of their coronavirus vaccine for children ages 5 to 11, a move that could help protect more than 28 million people in the United States.

The companies have said they were submitting data supporting the change to the Food and Drug Administration. The agency has promised to move quickly on the request and has tentatively scheduled a meeting on Oct. 26 to consider it. A ruling is expected between Halloween and Thanksgiving.

Parents across the United States are anxiously awaiting the regulator’s decision, which could affect family life and the operation of schools. Clearance depends not only on the strength of the companies’ clinical trial data, but on whether they can prove that they are able to properly manufacture a new pediatric formulation.

Dr. Janet Woodcock, the acting F.D.A. commissioner, said last week that children might require “a different dosage or formulation from that used in an older pediatric population or adults.”

Pfizer has proposed giving children one-third of the adult dosage. That might require adding more diluent to each injection or using a different vial or syringe. The company was expected to describe the method it intended to use in its submission to the F.D.A.

Credit…Sameer Al-Doumy/Agence France-Presse — Getty Images

Covid screening tests in France will no longer be free for unvaccinated people starting on Oct. 15, according to the French authorities, a change that signals a new phase in the government’s strategy to quell coronavirus infections by encouraging people to get inoculated.

Unvaccinated people will now essentially have to pay to enter cafes, restaurants and theaters, because under a law enacted this summer, entering many indoor venues requires proof of being fully vaccinated, of a recent negative test or of a recent Covid-19 recovery.

Tests will remain free for vaccinated people.

The introduction of the health pass prompted large protests over the summer, with demonstrators including people calling it an infringement on their freedom, vaccine conspiracy theorists, and activists on the far left and the far right.

The law also includes mandatory inoculation for health workers — representing about three million people in France — by Oct. 15. Although most have received at least a first vaccine dose, some have held out. About 3,000 health workers have been suspended as a result, the government said last week.

A sharp decline in the number of protesters and a surge in vaccination rates in recent months suggest that President Emmanuel Macron’s gamble to increase restrictions to encourage vaccination has paid off.

But with vaccination rates lagging again in recent weeks, the government renewed its mixture of mandates and inducements — including an ad campaign promoting the “desirable” effects of vaccines — to encourage people to get vaccinated.

France, one of the most vaccine-sceptical countries in the world, has now fully inoculated nearly 70 percent of its population against the coronavirus, one of the highest rates in Europe, according to data from The New York Times.

Covid tests for unvaccinated people will cost $25 to $50, according to French press reports.

“It is no longer legitimate to pay for unlimited comfort tests at taxpayers’ expense,” Prime Minister Jean Castex told the newspaper Les Echos last month, adding that tests prescribed by a doctor and those for minors would continue to be reimbursed.

“The rationale,” he said, “is to reimburse tests linked to real medical reasons, and to keep encouraging vaccination.”

In August, Germany also announced plans to end free Covid tests for the unvaccinated, scheduling the change for Oct. 11.

Credit…Sakis Mitrolidis/Agence France-Presse — Getty Images

Greece will lift some pandemic restrictions in regions where coronavirus cases have been the highest, its health minister said, starting on Saturday.

The move, initially implemented for two weeks, is part of a drive to grant greater freedoms to people who are fully vaccinated against the virus and to encourage a large unvaccinated population to get shots.

“Red areas” across much of northern Greece and some parts of central Greece implemented restrictions last month including a nighttime curfew from 1 a.m. to 6 a.m. and a ban on music in bars and restaurants, in attempt to quell a fourth wave of the virus.

Under the relaxed rules, as well as being able to play music, restaurants and entertainment venues will be allowed to host standing customers, the health minister, Thanasis Plevris, said at a news conference on Wednesday.

They will be open only to people who can show proof of vaccination or of recent recovery from Covid infection, however. Unvaccinated people will remain barred, in line with restrictions introduced last month that are scheduled to remain in place through March.

Those measures bar unvaccinated people from indoor venues, including cafes and restaurants, and oblige unvaccinated workers to undergo regular coronavirus tests at their own expense.

Mr. Plevris said the relaxation of the rules starting this weekend was not an effort to punish unvaccinated people.

“The philosophy is not that some people are being favored over others,” he said. “The measures for the unvaccinated are adequate. Those who are vaccinated can have greater freedoms.”

Vaccine hesitancy is relatively strong in Greece, where 57 percent of the population of nearly 11 million has been fully vaccinated, compared with about 63 percent in the wider European Union, according to the European Centre for Disease Prevention and Control.

Credit…Aaron Nesheim for The New York Times

Even as parents in the United States wrestle with difficult questions over vaccinating their children against the coronavirus, families in other countries have been offered a novel option: giving children just one dose of the vaccine.

Officials in Britain, Hong Kong, Norway and other countries have recommended a single dose of the Pfizer-BioNTech vaccine for children ages 12 and older — providing partial protection from the virus, but without the potential harms occasionally observed after two doses. On Wednesday, Sweden and Denmark joined the ranks, announcing that adolescents should get only one jab of the Moderna vaccine.

Health officials in those countries are particularly worried about increasing data suggesting that myocarditis, an inflammation of the heart, may be more common among adolescents and young adults after vaccination than had been thought.

The risk remains very small, and significant only after the second dose of an mRNA vaccine. But the numbers have changed the risk-benefit calculus in countries where new infections are mostly lower than in the United States.

Advisers to the Centers for Disease Control and Prevention reviewed data on myocarditis in June and unanimously voted to recommend the vaccine for children ages 12 and older, saying that the benefits far outweighed the risk.

Myocarditis was among the concerns that led the Food and Drug Administration to ask vaccine makers this summer to increase the number of children in clinical trials. The issue is likely to be the focus of intense discussion when agency advisers meet next week to review the evidence for vaccinations of children ages 5 to 11 years.

Credit…Ash Adams for The New York Times

The coronavirus seems to be in retreat in the United States, with instances of hospitalization and death both falling.

Although some states, such as Alaska, Maine and New Hampshire, are still seeing high figures, the number of virus cases across the country is down about 25 percent compared with a couple of weeks ago.

So, what stage is the country in with the pandemic? And how will developments such as a new antiviral treatment and the availability of booster shots affect things?

The Daily Poster

Listen to ‘The Daily’: The State of the Pandemic

What can the U.S. expect from the coronavirus this fall? And what do we know about booster shots and a possible new treatment?

Sorgente articolo:
Covid-19 Live: Pfizer Updates, Vaccine Mandates and Latest News – The New York Times

User ID Campaign ID Link
d9a95efa0a2845057476957a427b0499 l-99999979 Ugo Fiasconaro
d9a95efa0a2845057476957a427b0499 l-99999996 Conference
d9a95efa0a2845057476957a427b0499 l-99999993 B2B Keyword tool
d9a95efa0a2845057476957a427b0499 l-99999994 Small Business CRM