EU Health Agency Asks for Addition to AstraZeneca's COVID Vaccine Label

The European Union's (EU) drug regulator is asking for an addition to AstraZeneca's COVID-19 vaccine label to warn about a capillary leak condition side effect, the agency said Friday.

The European Medicines Agency (EMA) reviewed cases where six people received the AstraZeneca dose and afterward developed the rare capillary leak disorder. The EMA wants the side effect added to AstraZeneca's label.

Meanwhile, the agency is continuing to review the small number of people who developed heart inflammation after receiving the Pfizer-BioNTech or Moderna vaccine. "Further analysis is needed to determine whether there is a causal link with the vaccines," the EMA said.

Rare blood clots have been previously linked to AstraZeneca's vaccine. However, health officials have said this is outweighed by the advantages of getting the shot.

Vials of the AstraZeneca Vaccine
Vials of the AstraZeneca COVID-19 vaccine on June 3 in Rome. The European Medicines Agency is asking for an addition to the label that warns of a rare disorder. Antonio Masiello/Getty Images

For more reporting from the Associated Press, see below:

The EMA has approved a new manufacturing site for the Moderna COVID-19 vaccine, in a move that could substantially boost production for the EU.

In a statement Friday, the EMA says it had approved a site in Monts, France, operated by Recipharm. In addition to the new site approval, the EMA authorized several other sites to conduct batch control and testing.

This month, two locations in the U.S. were approved for production of vaccines destined for the 27-nation EU bloc. Any medicines or vaccines authorized for the EU market must first have their production facilities approved by the EMA.

The EMA says these newly approved sites are expected to result in an additional 1 million to 2 million vials of Moderna's coronavirus vaccine every month.

The EMA says it's recommending that people who have had a rare blood vessel syndrome not be immunized with AstraZeneca's COVID-19 vaccine.

The EMA also said it is studying cases of myocarditis, inflammation of the heart, and pericarditis, inflammation of the membrane surrounding the heart. Symptoms include shortness of breath and chest pain; the problems are usually temporary.

The EMA said it expects to finalize its review of such cases next month.

Europe, alongside the rest of the world, continues to deal with the COVID-19 pandemic.
Germany is lifting a blanket travel warning for countries with high coronavirus infection rates starting July 1.

Foreign Minister Heiko Maas says that "after many months of lockdown, we can look forward to greater normalcy that includes travel."

The general travel warning will be lifted next month for all countries that have fewer than 200 newly confirmed coronavirus cases per 100,000 inhabitants in a week.

But Maas cautioned that the pandemic isn't over yet and the rise of new variants means risks remain.

Countries with infection rates above 200 or a large share of concerning variants among new cases, like Britain, will remain on the government's list of risk areas. Germans are discouraged from traveling to such countries and people arriving in Germany from there will need to go into quarantine.

Meanwhile, confirmed coronavirus cases are continuing to rise in Russia, where authorities on Friday reported 12,505 new infections—a 25 percent increase from the number registered on Monday.

Moscow accounted for nearly half of the newly confirmed cases with 5,853, almost twice the number reported in Russia's capital at the beginning of the week. Despite the surge of infections, Moscow Mayor Sergei Sobyanin vowed earlier this week not to impose a lockdown.

In St. Petersburg, Russia's second-largest city, hours-long lines of ambulances have been spotted this week near hospitals treating COVID-19 patients. The city hosted a massive economic forum last week and is scheduled to host several matches of soccer's European Championship next week.

The Russian state coronavirus task force has reported a total of nearly 5.2 million virus cases and over 125,000 deaths in the pandemic. Most virus-related restrictions in Russia were lifted last summer, and authorities have shunned tough measures ever since.

In England, leaders from the Group of Seven industrialized nations are set to commit at their summit to sharing at least 1 billion coronavirus shots with struggling countries around the world—half the doses coming from the U.S. and 100 million from the U.K.

Vaccine sharing commitments from U.S. President Joe Biden and British Prime Minister Boris Johnson set the stage for the G7 meeting in southwest England, where leaders will pivot Friday from opening greetings and a "family photo" directly into a session on "Building Back Better From COVID-19."

"We're going to help lead the world out of this pandemic working alongside our global partners," Biden said. The G7 also includes Canada, France, Germany, Italy and Japan.

The leaders hope the meeting in the resort of Carbis Bay will also energize the global economy. On Friday, they are set to formally embrace a global minimum tax of at least 15 percent on corporations, following an agreement reached a week ago by their finance ministers. The minimum is meant to stop companies from using tax havens and other tools to avoid taxes.

It represents a potential win for the Biden administration, which has proposed a global minimum tax as a way to pay for infrastructure projects, in addition to creating an alternative that could remove some European countries' digital services taxes that largely hit U.S. tech companies.

Norway's King Harald V says he believes the coronavirus pandemic "is nearing its end" and people "should rejoice."

During the pandemic, several members of the Norwegian royal family were protectively put in quarantine and either canceled official duties or performed them digitally.

Harald formally heads the Council of State with the government and during its meetings he is briefed about current affairs and signs laws. In March, he took part in such a meeting by telephone.

The Norwegian monarch, whose duties are largely ceremonial, said Thursday the pandemic has meant that he and his wife, Queen Sonja, are "seeing far less of you than we normally do."

Norway has had one of Europe's lowest infection rates throughout the pandemic, chiefly because of the Scandinavian country's low population density. The Norwegian public's overall trust in government authorities also has been credited with keeping virus cases down.

Countries in Asia also continue to battle COVID-19.

Malaysia's government says a two-week nationwide lockdown due to end Monday will be extended for another two weeks as new daily infections remain high at more than 6,000.

Senior Minister Ismail Sabri said the National Security Council made the decision at its meeting Friday. Although daily cases have dropped from their peak of above 9,000 just before the lockdown, he said average daily cases since the lockdown was still high.

The health ministry on Friday reported 6,849 new infections, bringing the country's confirmed total tally to 646,411. Another 84 deaths raised the confirmed death toll to 3,768.

Philippine officials have allowed the reopening of gyms, skating rinks, racket courts and museums in metropolitan Manila and adjacent provinces as a coronavirus surge continues to ease.

Trade Secretary Ramon Lopez says Filipinos 65 years old and above who have been restricted to home can now travel within the densely populated capital region two weeks after having been fully vaccinated.

He says gyms and similar indoor businesses with safety certificates can reopen up to 30 percent of their capacity.

Lopez has called for the further reopening of the battered economy to address unemployment and hunger. Museums and historical sites also can reopen at 20 percent capacity, but guided tours remain prohibited.

The Philippines has reported the second-highest number of COVID-19 infections in Southeast Asia, at nearly 1.3 million with 22,312 dead. The government reimposed a lockdown in the capital region and four nearby provinces after infections surged in March.

In India, the state of Bihar has increased its COVID-19 death toll after the discovery of thousands of unreported cases, raising concerns that many more fatalities were not officially recorded.

The health department in Bihar, one of the poorest states, on Thursday revised its COVID-19 fatality count to more than 9,429 from 5,424—a jump of more than 70 percent.

Officials said the 3,951 unreported fatalities had occurred in May and reflect "deaths reported at private hospitals, in transit to health facilities, under home isolation and those dying of post-COVID-19 complications."

Health experts say many COVID-19 fatalities remain unrecorded in India. India's federal ministers from the ruling Bharatiya Janata Party have dismissed reports of undercounting as exaggerated and misleading.

Overall, India's cases and deaths have fallen steadily in the past weeks.

The 91,702 cases added in the past 24 hours pushed India's total to more than 29.3 million on Friday, second only to the U.S. The Health Ministry also reported 3,403 fatalities in the past 24 hours, raising the overall death toll to 363,079.

In the U.S., Chicago is lifting all capacity limits on bars, restaurants, businesses and other venues as of Friday, nearly 15 months after the state's first stay-at-home order of the coronavirus pandemic.

Businesses still can have their own rules for capacity, masks and social distancing. Masks are still required on public transportation and in airports, schools and hospitals.

More than 68 percent of Illinois residents who are 18 or older have received at least one dose of vaccine, and 51 percent of adults are fully vaccinated, the state health department said, citing federal data.

The health department said 209 people with COVID-19 were in intensive care units statewide Thursday and 103 were on ventilators—some of the lowest counts we've seen since the pandemic began."

There have been at least 23,014 deaths in Illinois from COVID-19.

U.S. health officials are investigating what appears to be higher than expected reports of heart inflammation in male teens and young adults after they get a second dose of the Pfizer and Moderna vaccines.

It's not clear if the inflammation is caused by the shots and the reports still are rare, the Centers for Disease Control and Prevention says. The CDC is urging everyone 12 and older in the U.S. to get vaccinated.

A CDC official said Thursday that as of May 31, the agency had 275 preliminary reports of such inflammation in 16- to 24-year-olds. That's out of more than 12 million second-dose injections of the vaccines.

The official says the cases seem to occur more often in men and younger people, and most already have fully recovered.

In Idaho, school district officials have started offering a full summer school program to help students who may have fallen behind academically during the coronavirus pandemic catch up.

In previous years, the Cassia County School District offered limited summer school to migrant programs or after-school programs, district spokesperson Debbie Critchfield told the Times-News.

"The Cassia School District hasn't offered open and full summer school programs for any student in more than 20 years and perhaps longer. Those around now can't recall it outside very specific schools or student participation," Critchfield said.

Raft River Elementary School Principal Melina Ficek, who is coordinating the full summer program for the district, said it was launched because students who recently returned to school were "further behind than before."

Officials said 840 students signed up out of an average student population of 5,500 across the district.

White Pine Elementary School Principal Diana Gill said parents were thrilled when the decision was made to hold a summer program. About one in six students out of the school's 600 students showed up for the first day of summer school Monday.

Businesses in California remain baffled by the shifting rules over who needs to wear masks and where as the nation's largest state fully reopens from the pandemic on Tuesday.

While Governor Gavin Newsom's health agency has said vaccinated people won't need to wear face coverings in many public places, state regulators—following several lengthy and hotly contested debates—are still drafting rules for workers.

That has some business leaders clamoring for Newsom, who will likely face a recall election in the fall, to step in and order just one set of mask rules for California's 40 million people.

"We asked the governor to issue an executive order to align the rules," said Lucy Dunn, president and chief executive of the Orange County Business Council. "Otherwise, it's just terribly confusing."

With vaccinations rising and coronavirus cases low, California will end most mask rules on June 15 for people who are vaccinated while continuing to require face coverings for unvaccinated people in indoor public settings and businesses. Everyone will need to remain masked in some places such as public transit and indoor school classes.

Johnson & Johnson says U.S. health officials have extended the expiration date for millions of doses of its coronavirus vaccine by an extra six weeks.

The drugmaker says the Food and Drug Administration approved a longer shelf life for the one-dose shots. State officials recently warned that many unused doses would reach their original three-month expiration by the end of June.

The extension comes as the rate of new U.S. vaccinations continues to slip. The U.S. averaged about 800,000 injections per day last week. That's down from a high of nearly 2 million per day two months ago.

Biden's goal is 70 percent of American adults partially vaccinated by July 4. The CDC says about 64 percent of Americans 18 and above have received at least one dose.

India's Version of the AstraZeneca Vaccine
A health worker administers the Covishield COVID-19 vaccine in Hyderabad, India, on June 11. Mahesh Kumar A./AP Photo