The Latest: Europe regulator: No new vaccine side effects

The European Medicines Agency says no new side effects linked to the coronavirus vaccine made by BioNTech and Pfizer were identified in the regulator’s first safety update on COVID-19 vaccines

Via AP news wire
Friday 29 January 2021 09:36 GMT
Virus Outbreak Sri Lanka
Virus Outbreak Sri Lanka (Copyright 2021 The Associated Press. All rights reserved.)

AMSTERDAM — The European Medicines Agency says no new side effects linked to the coronavirus vaccine made by BioNTech and Pfizer were identified in the regulator’s first safety update on COVID-19 vaccines.

In a statement published Friday, the European regulator said its expert committee assessed reports of people who died after getting the vaccine and said their review “did not suggest a safety concern.” Earlier this month, Norwegian officials amended their vaccination advice to say that doctors should assess frail and severely ill elderly people to decide if they should be immunized.

The EMA concluded that safety data collected on the Pfizer vaccine are “consistent with the known safety profile of the vaccine” and noted that severe allergic reactions are a known, rare side effect. It said the frequency of such allergic reactions was about 11 cases per million doses in the U.S. but that there was no comparable European estimate yet.

The EMA authorized the Pfizer vaccine on December 21 and granted it a conditional license; Pfizer and BioNTech must submit safety reports every month in line with a heightened monitoring process. The agency said “there are no recommended changes regarding the use of the vaccine.”

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THE VIRUS OUTBREAK:

The U.S. reports first case of South Africa virus variant found in South Carolina. More than 90 million doses of the AstraZeneca COVID-19 vaccine will be produced in Japan. No respite for UK hospital workers facing record number of patients. EXPLAINER: Why it’s hard to make vaccines and boost supplies.

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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:

MADRID — The coronavirus pandemic dragged Spain’s economic output down 11% in 2020 from the previous year, according to official preliminary statistics released Friday.

The year closed with the fourth largest economy among the nations that use the euro currency shrinking for the first time after six years of continuous growth. Output grew by 2% in 2019 compared to 2018.

The economy grew in the last three months of 2020 by a meagre 0.4%, mostly driven by internal consumption and investment, after a 16.4% quarter-to-quarter growth from April to June. The timid growth from October to December surprised some analysts who were forecasting an imminent return to recession.

Spain’s statistics agency, INE, also said that inflation grew by 0.6% in January 2021 compared to the same month of 2020, the first time that prices increased since COVID-19 hit the country.

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BUDAPEST, Hungary — Hungary’s prime minister says a deal to purchase Chinese coronavirus vaccines could be concluded as early as Friday, which would make Hungary the first country in the European Union to purchase a vaccine from China.

Prime Minister Viktor Orban said on public radio that his government is monitoring the use of a vaccine developed by Chinese state-owned company Sinopharm in neighboring Serbia, which became the first European country to administer the drug after it received 1 million doses earlier this month.

Hungary’s drug regulator has not yet approved the Sinopharm vaccine. But a decree ordered by the government on Thursday streamlined the approval procedure by allowing any vaccine that had been administered to at least 1 million people to be used in Hungary.

Orban said he would personally choose to be inoculated with the Sinopharm vaccine since he trusted it the most.

Hungary last week was the first EU member to approve the Russian Sputnik V vaccine, and has ordered doses to treat 1 million people over the next three months. Orban has been critical of the EU’s vaccine procurement program and insisted that countries that pursue their own vaccine agreements are faring better.

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COPENHAGEN, Denmark — Denmark has extended restrictions that close food shops, except for grocery stores and pharmacies, schools and public gatherings of more than five people for another three weeks until the end of February.

Prime Minister Mette Frederiksen said “we have seen how quickly the new mutation can get things out of control. Therefore, we cannot relax the restrictions. Even when we get vaccinated more, we must proceed cautiously.”

Cafes and restaurants remain closed but can still sell takeout food. Gyms, public libraries, beauty parlors and hairdressers also will remain shut until Feb. 28.

Advice to avoid non-essential travel — including business trips — outside of Denmark also was extended to the end of February, with Foreign Minister Jeppe Kofod saying it was “an important element in the effort to control the spread of infection as the mutations of coronavirus occur in several countries.”

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COLOMBO, Sri Lanka — Sri Lanka on Friday began inoculating front-line health workers, military troops and police officers against COVID-19 amid warnings that the medical sector faces a collapse because of health personnel being infected with the coronavirus.

Sri Lanka on Thursday received 500,000 vaccine doses as a donation from neighboring India. The Oxford-AstraZenica vaccine also known as the COVISHIELD is manufactured by the Serum Institute of India.

The government says 150,000 health workers and 115,000 military and police will be given primary access to the vaccine.

Sri Lanka has been experiencing a new outbreak of the disease since October with the emergence of two clusters — one centered at a garment factory and other at a fish market.

Sri Lanka has reported a total of 61,585 cases, including 297 fatalities.

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TOKYO — Japan’s minister in charge of the coronavirus vaccine rollout warned the public on Friday against scams in which callers ask for payments to reserve inoculation slots.

Taro Kono, minister for administrative affairs, stressed the innoculations, set to start next month, are free.

“We want to make sure our message is getting relayed,” Kono told reporters, acknowledging such attempts may grow.

Local government offices have been deluged with inquiries about vaccine-related telephone calls wanting cash or personal information, he said.

Cases of COVID-19 infections have been growing recently, with more than 5,000 deaths so far.

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BEIJING — New cases of local transmission in China are continuing to fall with just 36 announced on Friday, even as the country’s annual Lunar New Year travel push gets underway.

Authorities have taken a variety measures to discourage travel this season and far few Chinese appear willing to make the trip, even though it might be their only chance to return home and see family all year.

The northeastern province of Heilongjiang reported the largest number of new cases, 21, over the past 24 hours, followed by Jilin province just to the south. The capital Beijing and its surrounding province of Hebei both reported one new case each.

Also Friday, inspectors from the World Health Organization began day two of a fact finding tour in the central Chinese city of Wuhan clusters of the virus were first detected in late 2019.

The mission has become politically charged, as China seeks to avoid blame for alleged missteps in its early response to the outbreak. A major question is where the Chinese side will allow the researchers to go and whom they will be able to talk to.

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UNITED NATIONS -- The United Nations chief is calling the distribution of COVID-19 vaccines a “global emergency,” saying more that 70 million doses have been administered but fewer than 20,000 vaccinations were on the African continent.

Secretary-General Antonio Guterres warned Thursday that while every country has the duty to protect its own people “no country can afford to neglect the rest of the world.”

He called “vaccine nationalism” both a moral and economic failure and said: “We need a global vaccination campaign to deal with a global pandemic.”

If COVID-19 continues circulating in the global south, it will inevitably mutate, Guterres told a news conference. New variants could be more deadly and more transmissible and threaten the effectiveness of current vaccines, “prolonging or risking to prolong the pandemic significantly.”

Research by the International Chamber of Commerce showed that without support to the developing world, “this crisis could cost the global economy up to $9.2 trillion –- almost half, including in the wealthiest countries,’’ the secretary-general said.

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WASHINGTON — The Pentagon says it is reviewing a request from the Federal Emergency Management Agency for military troops to help set up vaccination sites, as the Biden administration vows to speed up deliveries of the COVID-19 vaccine over the next few weeks.

Pentagon chief spokesman John Kirby told reporters Thursday that the military will help as aggressively as it can, and it will likely require a mix of active-duty troops as well as National Guard and Reserves to meet FEMA’s needs.

According to a draft of the request, FEMA wants the military to set up 100 teams that will help operate vaccination centers across the country. Kirby and other Pentagon officials said Thursday that talks are still ongoing to determine how many service members it will take and who they will be.

FEMA initially asked for as many as 10,000 troops, but defense officials say it may not require that many.

Since a key job will be to actually give shots to the public, officials have to determine what military personnel can do that without taking key capabilities from other units, including some that may be deployed. In addition, many health care professionals who are in the Guard and Reserves are already working at critical medical jobs, and may not be available for the vaccination centers.

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ALBANY, N.Y. — New York may have undercounted COVID-19 deaths among nursing home residents by thousands. That’s according to a new report from the state attorney general that dealt a blow to Democratic Gov. Andrew Cuomo’s claims that his state is doing better than others in protecting its most vulnerable.

Attorney General Letitia James has, for months, been examining discrepancies between the number of deaths being reported by the state’s Department of Health, and the number of deaths reported by the homes themselves. Her investigators looked at a sample of 62 of the state’s roughly 600 nursing homes. They reported 1,914 deaths of residents from COVID-19, while the state Department of Health logged only 1,229 deaths at those same facilities

The report backed up the findings of an Associated Press investigation last year. The official 8,711 nursing home toll could actually be more than 13,000, highest in the nation.

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MEXICO CITY — Mexican President Andrés Manuel López Obrador has only shared a photo of himself since testing positive for the coronavirus.

His aides say little more than the leader is in good spirits, experiencing mild symptoms and working. But the country has grown accustomed to waking to the 67-year-old López Obrador as he conducts marathon news conferences each morning.

His public absence since the weekend announcement of his illness is spurring calls that the president who touts the transparency of his administration to share more about his health.

López Obrador played down the coronavirus threat early, has rarely been seen wearing a mask in public and at times contradicted his own health officials’ recommendations. The president is a heart attack survivor who has high blood pressure.

Michelle Varela, an economist, says she hopes after his illness, López Obrador will take precautions to set an example. Mexico has 1.8 million confirmed cases and more than 153,000 confirmed deaths, the fourth-highest death toll in the world.

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COLUMBIA, S.C. — A new coronavirus variant identified in South Africa has been found in the United States for the first time.

South Carolina officials say two such cases have been diagnosed in the state. The two cases don’t appear to be connected, nor do the people have a history of recent travel, according to the South Carolina Department of Health and Environmental Control.

Viruses mutate constantly and many variants of the coronavirus are circulating around the globe. However, scientists are primarily concerned with three that appear to spread more easily.

Other variants first reported in the United Kingdom and Brazil were already confirmed in the U.S. Researchers predicted it was only a matter of time before the variant identified in South Africa reached the United States as well.

President Joe Biden on Monday reinstated COVID-19 travel restrictions on most non-U.S. travelers from Brazil, the U.K. and South Africa. The CDC is currently recommending Americans not travel.

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