The Latest: Johnson & Johnson single shot awaits approval

By | February 24, 2021

WASHINGTON – An analysis by U.S. regulators say Johnson & Johnson’s single-dose vaccine protects against COVID-19.

The report Wednesday confirmed the vaccine is about 66% effective overall at preventing moderate to severe COVID-19.

On Friday, a panel of experts to the Food and Drug Administration will debate if the evidence is strong enough to recommend the vaccine. The FDA is expected to make a final decision within days.

If the FDA clears the J&J shot for U.S. use, it won’t boost vaccine supplies significantly right away. Only a few million doses are expected to be ready for shipping in the first week.

J&J tested its single-dose option in 44,000 people in the U.S., Latin America and South Africa. J&J previously announced the vaccine worked better in the U.S. — 72% effective against moderate to severe COVID-19, compared with 66% in Latin America and 57% in South Africa.

Still, in every country it was highly effective against the most serious symptoms, and early study results showed no hospitalizations or deaths starting 28 days after vaccination.

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THE VIRUS OUTBREAK:

— Johnson & Johnson single-dose COVID-19 shot poised for FDA decision

— U.S s tates scramble to catch up after weather disruptions, hope to administer more shots as vaccine supply increases

— UK to push at G-7 for global standard for vaccine passports

— A food fight erupts in France over serving meatless school lunches during pandemic

— Follow all of AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus-vaccine and https://apnews.com/UnderstandingtheOutbreak

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HERE’S WHAT ELSE IS HAPPENING:

BUDAPEST — Hungary became the first country in the European Union to begin using a COVID-19 vaccine produced in China and expects to inoculate up to 275,000 people by the end of the week.

Medical staff around the Central European country were instructed to administer the shots, developed by Chinese state-owned company Sinopharm, to elderly patients. The Sinopharm shot brings the number of vaccines currently in use in Hungary to five, more than in any other country in the EU.

“Today is an important day, because we are starting to administer the Chinese vaccine,” Prime Minister Viktor Orban said in a video on Facebook on Wednesday, who plans to get the shot next week.

Hungary has agreed to purchase 5 million doses of the Sinopharm vaccine in the next four months, enough to inoculate 2.5 million people with the two-round shot in the country of 10 million.

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CENTRAL FALLS, R.I. — Two predominantly Latino cities in neighboring states have had diverging fates in the global rollout of the coronavirus vaccine.

Central Falls, Rhode Island, and Chelsea, Massachusetts, have been the hardest-hit communities in the states. Rhode Island has opened up vaccinations to all Central Fall residents 18 or older, and city officials say they’re on pace to inoculate most residents by the summer.

Massachusetts hasn’t done the same for Chelsea or other hard-hit communities of color. Public health experts, civil rights groups and immigrant activists have said for months the state, led by Republican Gov. Charlie Baker, isn’t doing nearly enough to ensure that Black and Latino residents are inoculated.

White residents have so far received 66% of all doses in the state while Black residents have received about 5% and Latino residents 4%, according to state data. Meanwhile, Black and Latino residents are dying from the virus at three times the rate of whites in Massachusetts, by some measures.

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BERLIN — Authorities in Austria say all residents of an Alpine town will be required to take coronavirus tests after a cluster of cases involving the South African variant was discovered there.

Officials in Tyrol state say 29 of the 42 COVID-19 cases confirmed in Mayrhofen involved the virus type that experts say may be more resistant to currently available vaccines than the dominant variant.

Residents can only leave the town between Saturday and Wednesday if they present a negative PCR test result for the coronavirus, considered the ‘gold standard’ for testing. Schools, kindergartens, non-essential stores and churches will remain closed for a week.

Outbreaks in Tyrol have caused concern in Austria and beyond for leading to the spread of infections throughout Europe as tourists carry the virus back home from vacations.

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Beijing — China is moving ahead with two more COVID-19 vaccines in the regulatory process, one from state-owned company Sinopharm and another from a private company CanSino.

Both vaccines have submitted been to regulators for approval this week. CanSino said that Chinese regulators are reviewing its application for its COVID-19 vaccine, in a stock filing on Wednesday. Sinopharm’s subsidiary the Wuhan Institute of Biological Products announced Wednesday that it had submitted an application Sunday and that regulators were reviewing it.

China already has approved two vaccines that it has been using in a mass immunization campaign. One of them is also from Sinopharm, but it was developed by its Beijing subsidiary. The other is the Sinovac vaccine.

The Wuhan shot from Sinopharm is 72.51% effective, the company said. Both shots from Sinopharm rely on inactivated viruses, a traditional technology.

CanSino’s vaccine is a one-dose shot that relies on a harmless common cold virus, called an adenovirus, to deliver the spike gene of the virus into the body. The technology is similar to both Astrazeneca and Johnson & Johnson’s vaccines, which rely on different adenoviruses.

CanSino’s vaccine is 65.28% effective, the company said Wednesday.

Neither company has published its trial data in peer-reviewed scientific journals yet.

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ACCRA, Ghana — Ghana has become the first country in the world to receive vaccines acquired through the U.N.-backed COVAX initiative, with a delivery Wednesday of 600,000 doses of the AstraZeneca vaccine made by the Serum Institute of India.

The vaccines shots, delivered by UNICEF, arrived at Accra’s Kotoka International Airport and are part of the first wave of COVID-19 vaccines that COVAX is sending to several low- and middle-income countries.

Ghana is among 92 low-and middle-income countries that are receiving vaccines for free through COVAX program, which aims to ensure wider access to vaccines around the world. Another 90 countries and eight territories have agreed to pay to receive vaccines through COVAX.

The West African nation of 30 million has recorded 81,245 coronavirus cases and 584 deaths in the pandemic.

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LISBON, Portugal — Portuguese officials say the unexpectedly slow pace of vaccine deliveries likely means delays for plans to send batches to the country’s former colonies in Africa and Southeast Asia.

Portugal has promised to send 5% of the vaccines it receives to five African countries and East Timor. Foreign Minister Augusto Santos Silva said Wednesday the government estimates it will be able to start sending vaccines abroad only in the second half of the year.

He said, “The goal is not compromised. The timing just needs to be adjusted.”

Portugal has already sent medical equipment worth 3.5 million euros ($ 4.3 million) to East Timor, Angola, Mozambique, Cape Verde, Guiné-Bissau and São Tomé e Príncipe.

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COPENHAGEN, Denmark — Denmark eased some coronavirus restrictions on Wednesday, saying older students in the north and east can return to school while some larger non-food shops can reopen on Monday.

So far, Denmark has kept all shops except food stores and pharmacies closed. Earlier this month, schools resumed teaching younger children up to the fourth grade.

A limit of 5 people in outdoor public gatherings was raised to 25 people during organized sports.

Health Minister Magnus Heunicke said the reopenings meant more infections and more hospitalizations were expected but with a mild spring coming and the nation’s vaccination program, further reopenings were possible.

Denmark has seen 2,343 deaths and 208,556 cases.

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PRAGUE — The Czech prime minister says the pandemic situation in his country, one of the hardest-hit in the European Union, is “extremely serious” and his government will have to impose more restrictions to slow down the spread of the coronavirus.

Prime Minister Andrej Babis says the measures are needed to prevent “a total catastrophe” in hospitals that have been coming close to their limits.

The government will decide those measures later Wednesday. Babis says they will be similar to those in place last spring when the borders and schools were completely closed. He also mentioned possible restrictions to limit movement of people.

Babis says the situation might be the worst on March 1, the anniversary of the first cases recorded in the Czech Republic.

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Babis spoke amid a surge of new coronavirus cases caused by a highly contagious variant originally found in Britain as hospitals are filing up.

The day-to-day increase f new confirmed cases reached 15,672, about 3,000 more than a week ago. A total of 6,817 COVID-19 patients needed intensive care.

The country had almost 1.2 million confirmed cases with 19,682 deaths.

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NEW DELHI — India will start inoculating people above 60, and those with underlying health problems above age 45 in the second phase of its massive vaccination drive from March 1.

India’s Information and Broadcasting Minister Prakash Javadekar says the vaccinations will be done in 10,000 public and 20,000 private hospitals. Javadekar told reporters on Wednesday that vaccine shots in government hospitals will be free, but did not say how much it will cost in private hospitals.

India started inoculating health workers beginning on Jan. 16.

India is home to the world’s largest vaccine makers. The government has authorized emergency use of Oxford-AstraZeneca vaccine, manufactured by Serum Institute of India, and a homegrown vaccine developed by Bharat Biotech.

Cases of COVID-19 are increasing in some parts of India after months of a steady nationwide decline In many cities, markets are bustling, roads are crowded and restaurants are nearly full. The country is reporting about 11,000 to 13,000 new cases a day, compared to a peak of nearly 100,000. in September.

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BANGKOK — Thailand on Wednesday received its first delivery of COVID-19 vaccine for mass inoculations, 200,000 doses from the China-based company Sinovac.

The lot received by Prime Minister Prayuth Chan-ocha at Bangkok’s Suvarnabhumi airport is part of a total 2 million doses the government earlier reserved from Sinovac.

The government plans to start vaccinations in 13 high-risk provinces on March 1. They will be for frontline medical personnel, officials with exposure to infected patients, and people with congenital diseases.

About a third of the initial 200,000 doses is earmarked for Samut Sakhon province, near Bangkok, where an outbreak last year set off a surge of coronavirus infections.

Tourism Minister Pipat Ratchakitprakan said some doses have been reserved for workers in the tourism sector to help promote a revival of the hospitality industry, which was badly hurt by restrictions to fight the spread of the coronavirus.

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KUALA LUMPUR, Malaysia — Prime Minister Muhyiddin Yassin received Malaysia’s first COVID-19 vaccine shot on Wednesday at the start of its inoculation campaign.

“I did not feel anything at all. It was all over before I realized, just like a normal injection,” he said at a ceremony broadcast live.

Health Director-General Noor Hisham Abdullah was also among the first to be vaccinated.

Malaysia, which has signed deals with several vaccine suppliers including Pfizer and AstraZeneca, aims to vaccinate up to 80% of its 32 million people by next year. More than half a million health care and front-line workers will be given priority in the first phase.

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CANBERRA, Australia — Two elderly people have received higher-than-prescribed doses of the Pfizer vaccine, Australia’s health minister said Wednesday.

The 88-year-old man and 94-year-old woman were being monitored and the doctor who administered the shots has been removed from the vaccination program, Health Minister Greg Hunt said.

The error occurred at the Holy Spirit aged care home in the Brisbane suburb of Carseldine on Tuesday, the day after the vaccine rollout in Australia began, Hunt said.

“Both patients are being been monitored and both patients are showing no signs at all of an adverse reaction,” Hunt said.

Lincoln Hopper, chief executive of St. Vincent’s Care Services that owns the home, said he was “very concerned” for the residents’ welfare. The woman remained at the home while the man has been admitted to a hospital, Hopper said.

“This incident has been very distressing to us, to our residents and to their families and it’s also very concerning,” Hopper said. “It’s caused us to question whether some of the clinicians given the job of administering the vaccine have received the appropriate training.”

Hunt later revealed that the doctor who administered the overdoses had not completed the online training that all health professionals in the program must undertake.

Hunt apologized for earlier telling Parliament that the doctor had been trained. He said he had asked the Health Department to take action against the doctor and the company the doctor works for.

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ANKARA, Turkey — Turkey has started administering vaccines to teachers as it prepares for a gradual re-opening of schools.

Education Minister Ziya Selcuk, who received the first shot on Wednesday, said 1.25 million teachers and other school staff are being prioritized for vaccines along with health care workers and people above 65.

Schools in rural areas resumed in-person education on Feb. 15. Schools in other parts of the country are to re-open on March 1, with many students attending classes twice a week only. Students preparing for high school and university entrance exams are scheduled to attend classes full time.

More than 7 million people have received shots of the vaccine developed by China’s Sinovac company.

Turkey has reported more than 2.6 million confirmed infections and 28,000 deaths.

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SEOUL, South Korea — South Korea’s top infectious disease expert has warned that vaccines will not end the coronavirus pandemic quickly as the country prepared to give its first vaccinations this week.

Jeong Eun-kyeong, director of the Korea Disease Control and Prevention Agency, said during a briefing Wednesday it would take a “considerably long time” before the vaccination campaign brings the virus under control.

The country aims to vaccinate more than 70% of its population by November. But a safe return to mask-less normalcy is highly unlikely in 2021, due to the growing spread of virus variants and other factors, said Choi Won Suk, an infectious disease professor at the Korea University Ansan Hospital who joined Jeong at the briefing.

“We are concerned that people might drop their guard as vaccination begins, triggering another massive wave of the virus,” Jeong said.

South Korea on Wednesday began transporting its first available doses of vaccines that rolled off a production line in the southern city of Andong, where local pharmaceutical company SK Bioscience manufactures vaccines developed by AstraZeneca and the University of Oxford.

The country will kick off its mass immunization campaign on Friday. Separately, 55,000 doctors, nurses and other health professionals treating COVID-19 patients will begin receiving shots of the Pfizer-BioNTech vaccine on Saturday.

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JERUSALEM — Israel’s government has approved a night-time curfew from Thursday until Sunday to prevent the spread of the coronavirus over the Purim holiday.

The Prime Minister’s Office and Health Ministry said a curfew from 8:30 p.m. until 5 a.m. would be in force starting Purim eve.

Purim, a Jewish holiday traditionally marked with public festivities and gatherings, begins Thursday at sundown. The holiday lockdown prohibits any large gatherings of more than 10 people indoors at concerts, parades or parties typical of the holiday’s observances.

Israel reopened its economy last week after a nearly two-month lockdown, the country’s third since the start of the pandemic. But recent days have seen a slight uptick in new infections.

It has one of the highest immunization rates per capita, with over 4.5 million of its citizens having received at least one dose of the coronavirus vaccine. The Health Ministry has reported over 759,000 cases and at least 5,634 deaths from COVID-19.

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MEMPHIS, Tenn. — More than 2,400 doses of COVID-19 vaccines in Tennessee’s most populous county went to waste while local officials sat on tens of thousands of shots they thought had already gone into arms, the state’s top health official announced Tuesday.

The Department of Health began an investigation over the weekend into a report that recent winter storms caused 1,000 doses to be tossed in Shelby County, which encompasses Memphis.

But Health Commissioner Lisa Piercey on Tuesday revealed that the problems were far more widespread. She said issues dating back to Feb. 3 included multiple incidents of spoiled doses, an excessive vaccine inventory, insufficient record-keeping and a lack of a formal process for managing soon-to-expire vaccines. A federal investigation is also expected.

As a result, Shelby County’s local health department will temporarily no longer be allowed to allocate the vaccine. Instead, Memphis city officials, hospitals, clinics and other pharmacies will handle the distribution. Meanwhile, the physical management of the vaccine will now be handled by hospital partners.

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