LONDON — The European Medicines Agency says its expert committee has concluded that the COVID-19 vaccines made by Pfizer and Moderna are possibly linked to very rare cases of chest pain and heart inflammation in some people following vaccination.
That echoes a similar conclusion reached by U.S. officials in June. In a statement on Friday, the EU drug regulator is recommending that the two conditions, myocarditis and pericarditis, be included as side effects on the vaccine labels, together with a warning to raise awareness among health workers and people receiving the shots.
The decision was made based on a review of more than 300 cases of chest and heart inflammation among more than 190 million doses of the two vaccines administered across Europe. Health officials say the benefits of the coronavirus vaccines far outweigh the small risks of side effects.
Also, the EMA is recommending people who have a history of a rare condition that causes blood vessels to leak avoid the coronavirus vaccine made by Johnson & Johnson. Its experts examined three cases of capillary leak syndrome in people who received the J&J vaccine; two died shortly after being vaccinated.
The regulator says the syndrome should be recognized as a new side effect of the J&J shot and advised a warning to raise awareness among health workers.
MORE ON THE PANDEMIC:
— Pfizer to seek OK for 3rd vaccine dose; CDC says booster shots not yet needed
— Afghanistan getting vaccine doses donated by United States
— AP Photos: With 4 million COVID dead, many kids left behind
— Coronavirus vaccines work against delta variant, researchers find
Follow more of AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic and https://apnews.com/hub/coronavirus-vaccine
HERE’S WHAT ELSE IS HAPPENING:
BUDAPEST — Hungary’s capital city is offering free antibody testing to older people amid concerns that certain COVID-19 vaccines don’t provide adequate protection.
The offer of 20,000 tests Friday came after fully vaccinated people reported that tests carried out at private laboratories indicated they hadn’t developed antibodies to defend against the coronavirus.
City leaders say most such reports came from people who received China’s Sinopharm vaccine.
An early vaccination leader in the European Union, Hungary is the only country in the bloc to use the Chinese shot.
Budapest’s mayor is pushing for Hungary’s government to offer third shots for those that need them.
BERLIN — Germany is listing Spain as a “risk area,” putting the popular tourist destination in the lowest of its three risk categories – a move with few practical effects for travelers but may put off would-be vacationers.
Germany’s national disease control center says the new status will take effect on Sunday. Parts of Spain, including Andalucia and Catalonia, were already on the list. They are now joined by the rest of the country – including the Balearic Islands, which are hugely popular with Germans.
Anyone arriving from a “risk area” can avoid a 10-day quarantine by proving they have tested negative. People flying to Germany are required to test negative before boarding a flight wherever they come from.
Effective Sunday, Germany is putting Cyprus in its second-highest risk category as a “high-incidence area.” People arriving from countries on that list can avoid quarantine if they can prove that they are fully vaccinated or have recovered from COVID-19. Others can cut short the 10-day quarantine by testing negative after five days.
KABUL, Afghanistan — U.N. children’s agency UNICEF says more than 1.4 million Johnson & Johnson vaccine doses will be delivered to Afghanistan on Friday as the country battles a third wave of infections.
The COVID-19 vaccines are being donated by the United States and delivered through the U.N.-backed COVAX program. Another shipment is expected to arrive later this month, bringing the total donations to around 3.3 million doses.
“These vaccines arrive at a critical time for Afghanistan as the country faces a difficult surge in COVID-19 infections,” Hervé Ludovic De Lys, UNICEF’s representative in Afghanistan, said in a statement.
He added while the the donated vaccines are appreciated, “much more needs to be done. I hope that other governments will step up and share their doses, supplies and therapeutics to protect those most in need.”
As of July 8, Afghanistan had reported a total a total of 131,586 confirmed COVID-19 cases and 5,561 deaths. Since the third wave started last month, the country has averaged more than 2,000 new confirmed cases a day. The Afghan government has closed universities and schools.
ISLAMABAD – Pakistani’s minister for planning and development said Friday there are clear signs that the fourth wave of coronavirus infections is starting in the Islamic nation.
Asad Umar said on Twitter that widespread disregard for social distancing rules and the emergence of the delta variant first identified in India were the two main causes.
His announcement came weeks after authorities said the country’s third COVID-19 wave had ended but that a fourth could start in July.
Pakistan reported 1,737 new cases and 25 more deaths on Friday.
Prime Minister Imran Khan urged people the day before to adhere to infection-prevention recommendations to avoid a lockdown.
Since last year, Pakistan has reported 969,476 confirmed cases and 22,520 virus-related deaths.
SYDNEY — Australian authorities are tightening restrictions in Sydney after reporting 44 new community cases, the largest number since a coronavirus outbreak began there last month. The city of more than 5 million is already in lockdown.
New South Wales State Premier Gladys Berejiklian said new restrictions would limit the number of people who can exercise together to two in most cases, and exercisers would need to stay close to home. The number of mourners at funerals would also be limited to 10 from Sunday.
Berejiklian said the state was facing it’s scariest test since the pandemic began and that unless numbers started to come down, authorities would likely extend the lockdown beyond next Friday.
She said the message was that people could not leave home unless it was absolutely necessary.
Authorities also deployed at least 100 extra police officers to ensure lockdown compliance.
The highly contagious delta variant outbreak began after a limousine driver tested positive on June 16. He is thought to have been infected while transporting a U.S. flight crew from Sydney airport.
SEOUL, South Korea – South Korea will enforce its strongest social distancing restrictions in the greater capital area starting next week as it wrestles with what appears to be the worst wave of the coronavirus since the start of the pandemic.
The plans, which may bring Seoul’s thriving nightlife to a standstill, were announced shortly before the Korea Disease Control and Prevention Agency reported another new 1,316 cases on Wednesday, breaking the country’s previous one-day record of 1,275 set the day before.
Nearly 1,000 of the cases came from Seoul and nearby metropolitan regions, home to half of the country’s 51 million people, where officials will elevate social distancing restrictions to an unprecedented “Level 4” for two weeks beginning Monday.
The measures include prohibiting private social gatherings of three or more people after 6 p.m., shutting down nightclubs and churches, banning visitors at hospitals and nursing homes and limiting weddings and funerals to family-only gatherings. Protests will be banned and shopping malls will have to close at 10 p.m.
South Korea has recorded more than 8,300 new cases so far this month. The surge in infections is a worrisome development in a country where a shortage in vaccine supplies has left 70% of the population still waiting for a first shot.
OTTAWA — Canada’s chief public health officer says there are cases of the latest COVID-19 variant of interest in the country, but it’s too early to know how widespread it is or what impact it could have.
Dr. Theresa Tam said Thursday 11 cases of the Lambda variant that was first identified in Peru last year have been reported to Health Canada to date. However, the National Institute of Public Health of Quebec said Thursday it has confirmed 27 cases already, all in March and April.
The Public Health Agency of Canada is monitoring Lambda to see how it spreads and how it responds to vaccines, Tam said.
“We’re just trying to gather up some information on who it is that’s having the Lambda variant right now, but there’s very few cases at this point,” she said.
Early studies, including one from New York University published July 2, suggest Lambda may be a bit resistant to antibodies produced by the mRNA vaccines from Pfizer-BioNTech and Moderna, but concluded it is not by enough “to cause a significant loss of protection against infection.”
ROME — Confirmed new coronavirus infections in Italy have topped 1,000 for the second straight day as health authorities voice growing concern over what they say appears to be a trend toward rising case numbers.
Health Ministry figures show 1,394 cases were registered in the last 24 hours compared with daily caseloads in the hundreds in previous weeks.
Virus experts credit vaccination with keeping the number of new ICU admissions low despite the higher caseloads, however.
Italy is stressing the importance of vaccines as the virus’ delta variant steadily gains traction.
So far 41% of people in Italy older than 12 and thus eligible to receive the shots are fully vaccinated, while an additional 20% or so have received an initial vaccine dose.
NEW YORK — New research from France adds to evidence that COVID-19 vaccines offer strong protection against the delta variant that is spreading rapidly around the world and now accounts for most U.S. infections.
The delta variant is surging through populations with low vaccination rates. Researchers from France’s Pasteur Institute reported new evidence Thursday in the journal Nature that full vaccination is critical.
In tests, a single dose of the Pfizer or AstraZeneca vaccines “barely inhibited” the delta variant. But after a second dose, almost all experienced a big boost in immunity.
Dr. Rochelle Walensky, director of the U.S. Centers for Disease Control and Prevention, says highly immunized swaths of America are getting back to normal while hospitalizations are rising in other places.
A few weeks ago, the delta variant accounted for just over a quarter of new U.S. cases. But it now accounts for just over 50%, and in some places, such as parts of the Midwest, as much as 80%.
LISBON, Portugal — Portuguese authorities are requiring a negative test or proof of vaccination for people wanting to enter restaurants and hotels at peak periods in areas where the coronavirus is surging.
The government announced Thursday it wants people to use the EU Digital COVID Certificate to patronize such businesses on Friday evenings, weekends and public holidays.
The high-risk areas are mostly around the capital Lisbon and in the southern Algarve vacation region.
The certificates, which can be downloaded to an app, certify EU citizens’ tests and vaccinations. They also allow them to travel between countries without having to quarantine or be tested.
Portugal’s coronavirus 14-day incidence rate has risen to 255 per 100,000 people in recent weeks, pushed higher by the more infectious delta variant.
NEW DELHI — India will spend $3.1 billion to create new health care facilities in preparation for another possible wave of coronavirus infections.
Health Minister Mansukh Mandaviya says officials will set up 50 field hospitals, 20,000 intensive care unit beds, 700 pediatric centers and storage facilities for medical oxygen in 700 districts within nine months.
Mandaviya says India has already increased the numbers of oxygen-supported beds to more than 400,000 from 50,000 in March 2021.
Prime Minister Narendra Modi’s government approved the new spending, with the federal government accounting for 65% of it and states 35%.
More than half of India’s reported 400,000 coronavirus deaths, third highest in the world, have occurred in the past two months as the delta variant overwhelmed its health system.
New cases are on the decline after exceeding 400,000 a day in May. Total confirmed cases stand at 30.7 million.
UNITED NATIONS — U.N. Secretary-General Antonio Guterres says the “grim milestone” of 4 million deaths worldwide shows the coronavirus is outpacing vaccine distribution and the pandemic is far from over.
Guterres says most of the world has not received vaccines and more than half the victims of the coronavirus have died this year.
“Many millions more are at risk if the virus is allowed to spread like wildfire,” Guterres said. “The more it spreads, the more variants we see — variants that are more transmissible, more deadly and more likely to undermine the effectiveness of current vaccines.”
The secretary-general called for “the greatest global public health effort in history” to bridge the vaccine gap.