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Emergent: FDA Lets Its Vaccine Factory Restart

FILE – In this April 8, 2021 file photo, the Johnson & Johnson COVID-19 vaccine is seen at a pop up vaccination site in the Staten Island borough of New York. The U.S. Food and Drug Administration is allowing the problem-plagued factory of contract manufacturer Emergent BioSolutions to resume production of COVID-19 vaccine bulk substance to resume, the company said Thursday, July 29. The Baltimore factory was shut down by the FDA in mid-April due to contamination problems that forced the company to trash the equivalent of tens of millions of doses of vaccine it was making under contract for Johnson & Johnson. (AP Photo/Mary Altaffer, File)

BALTIMORE, Md. — The U.S. Food and Drug Administration is allowing the troubled factory of contract manufacturer Emergent BioSolutions to resume production of COVID-19 vaccine bulk substance, the company said Thursday.

The Baltimore factory was shut down by the FDA in mid-April due to contamination problems that forced the company to throw out the equivalent of tens of millions of doses of vaccine it was making under contract for Johnson & Johnson.

The bulk vaccine was contaminated with an ingredient for AstraZeneca’s COVID-19 vaccine, which was made in the same factory. Emergent didn’t say when production will resume at the factory.

The productions problems forced J&J to import millions of doses from its factory in the Netherlands to the U.S. and to miss supply commitments. Emergent Chief Executive Robert Kramer said the company had fallen short of the public’s expectations.

The Biden administration has been working to find a different American manufacturing partner for British drugmaker AstraZeneca, whose COVID-19 vaccine isn’t authorized for distribution in the U.S.


HERE’S WHAT ELSE IS HAPPENING:

BEIJING — A disease-control official has called for increased testing of employees at China’s ports because of concerns about the coronavirus.

Roadblocks were set up to test drivers after a rash of coronavirus cases traced to a major airport. It’s rattled authorities who thought they had the disease under control.

The 171 new cases of the more contagious delta variant in the eastern city of Nanjing and surrounding Jiangsu province are modest compared with India and some other countries. But infections traced to Nanjing Lukou International Airport have spread to at least 10 cities.

Drivers who want to leave Jiangsu need to show a negative coronavirus test taken in the past 48 hours, the provincial transportation department announced Wednesday. It said 93 checkpoints were set up on highways.

Nanjing, a city of 9.3 million people northwest of Shanghai, ordered tens of thousands of people to stay home. It’s conducting mass testing while experts hunt for the source of the virus.

China has reported 92,811 confirmed cases and 4,363 deaths.


NAIROBI, Kenya — The World Health Organization’s Africa director says the continent of 1.3 billion people is entering an “encouraging phase after a bleak June” as supplies of COVID-19 vaccines increase.

But Matshidiso Moeti told reporters on Thursday that just 10% of the doses needed to vaccinate 30% of Africa’s population by the end of 2021 have arrived. Some 82 million doses have gotten to Africa so far, while some 820 million are needed.

Advertisement. Scroll to continue reading.

And the year-end vaccination target is just half the 60% population coverage that African health officials seek to achieve so-called herd immunity. The African continent is far behind on vaccinations as richer countries keep doses for their citizens.

Less than 2% of Africa’s population has been fully vaccinated, and the more infectious delta variant is driving a deadly resurgence of cases. The WHO says nearly 4 million vaccine doses arrived in Africa last week from the global COVAX facility, compared to less than 250,000 in all of June.

“There’s a light at the end of the tunnel on vaccine deliveries to Africa but it must not be snuffed out again,” Moeti said. She warned that countries’ decisions to provide a third, “booster” dose could influence decisions on sending vaccines to Africa.

Africa Centers for Disease Control director John Nkengasong told reporters that African countries might need more doses than previously thought as the delta variant spreads and younger people get COVID-19.


TOKYO — Japanese officials have sounded the alarm as Tokyo reported record-breaking coronavirus cases for the third straight day with the Olympics well underway.

Chief Cabinet Secretary Katunobu Kato told reporters the new cases are soaring not only in the Tokyo area but across the country. He says Japan has never experienced an expansion of infections of this magnitude.

Tokyo reported 3,865 new cases on Thursday, up from 3,177 on Wednesday and double the number it had a a week ago,

Japan has kept its cases and deaths lower than many other countries, but its seven-day rolling average is growing and now stands at 28 per 100,000 people nationwide and 88 in Tokyo, according to the Health Ministry.

People are still roaming the streets despite stay-at-home requests, making restrictions ineffective. The Tokyo governor says cases could hit 4,500 a day.

“While almost nothing is helping to slow the infections, there are many factors that can accelerate them,” said Dr. Shigeru Omi, a top government medical adviser, noting the Olympics and summer vacation. “The biggest risk is the lack of a sense of crisis.”


MADRID — Spain’s prime minister on Thursday announced that existing measures to protect the most vulnerable from the pandemic’s economic fallout will be prolonged until the end of October.

Spain, one of the country’s that was hardest hit at the beginning of the health emergency, has extended subsidies for the unemployed and furloughs for companies that have gone out of business to try to cushion an economic drop of 11% of its gross domestic product in 2020.

As a national lockdown extended in March last year, the government also rolled out a series of social measures, including a ban on leaving impoverished families without utilities and a moratorium on forced evictions for those who saw their income vanish.

During a televised briefing on Thursday to summarize progress during the first 1½ years of his left-wing coalition, Prime Minister Pedro Sánchez said that the so-called social shield will be extended beyond the current Aug. 9 expiration date to Oct. 31.

The change will be approved by the Cabinet next week, Sánchez said.

Advertisement. Scroll to continue reading.

New cases have spread mostly among people under 30, who largely haven’t received their vaccine shots yet, although the speed of infections spreading has plateaued in recent days.


TUNIS, Tunisia — Tunisia’s president has ordered the creation of a special body to manage the country’s coronavirus crisis amid raging infections and public anger over the government’s handling of the pandemic.

President Kais Saied made the announcement Wednesday, according to Tunisian media, saying the new virus operation would be run by the military health service and tasked with ensuring the enforcement of virus restrictions, managing medical stocks and coordinating national virus strategy.

Saied suspended parliament, fired the prime minister and took over all executive powers earlier this week after nationwide protests over Tunisia’s long-running economic crisis and the government’s management of the virus.

Tunisia has the highest virus death rate in Africa and has faced its worst COVID-19 outbreaks to date in recent weeks, with thousands of cases and more than 100 deaths daily in a country of 11 million, according to data from the government and John’s Hopkins University.


NAIROBI, Kenya — Burundi’s government now says it will accept COVID-19 vaccines, becoming one of the last countries in the world to embrace them. But the health ministry says it will not take responsibility for any side effects they might cause.

Health Minister Thaddee Ndikumana on Wednesday said the vaccines will arrive with the support of the World Bank. It was not immediately clear how many doses the East African country will receive or when.

“The vaccine will be given to those who need it,” the health minister said. The government will store the doses but will not take responsibility for any side effects, he added.

Burundi’s announcement came the same day that neighboring Tanzania launched its vaccination campaign, retreating from former President John Magufuli’s denial of the pandemic. He died in March and the presidency went to his deputy Samia Suluhu Hassan, who has since reversed course on COVID-19 in one of Africa’s most populous countries.

Burundi’s late President Pierre Nkurunziza, who died last year, also was criticized for taking the pandemic lightly. The administration of his successor, President Evariste Ndayishimiye, earlier this year said the country of more than 11 million people didn’t yet need COVID-19 vaccines.


BANGKOK — Health authorities in Thailand are racing to set up a large field hospital in a cargo building at one of Bangkok’s airports as the country reports record numbers of coronavirus cases and deaths.

Other field hospitals are already in use in the capital after it ran out of hospital facilities for thousands of infected residents. Workers rushed to finish the 1,800-bed hospital at Don Mueang International Airport, where beds made from cardboard box materials are laid out with mattresses and pillows.

The airport has had little use because almost all domestic flights were canceled two weeks ago. The field hospital is expected to be ready for patients in two weeks.

The airport, a domestic and regional hub, has had little use because almost all domestic flights were canceled two weeks ago.

The quick spread of the delta variant also led neighboring Cambodia to seal its border with Thailand on Thursday and order a lockdown and movement restrictions in eight provinces.

Advertisement. Scroll to continue reading.

VILNIUS, Lithuania — The Lithuanian government says it will donate 20,000 doses of the AstraZeneca coronavirus vaccine to Taiwan.

The Baltic country’s Health Ministry said Thursday that the donation “is a gift to the people of Taiwan to help to deal with insidious coronavirus infections. We feel an obligation to help other nations who need these jabs”.

Lithuania, a country of slightly less than 3 million, donated 20,000 vaccines each to other European countries — Armenia, Georgia, Moldova and Ukraine — earlier this year.

More than half of Lithuania’s population is either vaccinated or has recovered from COVID-19, although the infection rate has grown in recent weeks.

Lithuania’s 14-day coronavirus infection rate has now reached 91 cases per 100,000 persons.


MANILA, Philippines — Philippine President Rodrigo Duterte is warning that Filipinos who refuse to get vaccinated against the coronavirus will not be allowed to leave their homes as a safeguard against the more contagious delta variant.

Duterte said in televised remarks Wednesday night that there is no law mandating such a restriction but added he is ready to face lawsuits to keep people who are “throwing viruses left and right” off the streets.

The brash-talking president adds that for people who don’t want to be vaccinated, “well, for all I care, you can die anytime.”

However, more than public hesitance, the Philippines has been grappling with vaccine shortages.

Nearly 7 million Filipinos have been fully vaccinated and more than 11 million others have received their first dose. That is a fraction of the government’s target of 60 million to 70 million people.


CHICAGO — The hordes of people expected to descend on Chicago’s Grant Park for the Lollapalooza music festival this week will be required to show proof that they’ve been vaccinated for COVID-19 or tested negative for the disease within the last three days.

The four-day festival starts Thursday and is expected to be back at full capacity, with roughly 100,000 daily attendees. After missing last summer because of the threat of the coronavirus, it will easily be Chicago’s largest gathering since the pandemic started, and one of the country’s.

This year’s festival will look very different than in the past. To gain entry, attendees will have to present their vaccination cards or a printed copy of a negative COVID-19 test that is no more than 72 hours old. That means that anyone with a four-day pass who isn’t vaccinated will have to get tested twice. Furthermore, anyone who isn’t vaccinated will have to wear a mask.

Public health officials and others have raised concerns that such a large gathering, even outdoors, risks turning into a super-spreader event. Officials in the Netherlands were shocked after a much smaller music festival attended by 20,000 people over two days early this month led to nearly 1,000 cases of COVID-19, CNBC reported. That festival had similar safeguards to Lollapalooza’s.


WASHINGTON – The State Department says Secretary of State Antony Blinken has met the head of the World Health Organization to press for additional studies into the origin of the coronavirus pandemic in China.

Advertisement. Scroll to continue reading.

Blinken and WHO Director General Tedros Ghebreyesus met Wednesday in Kuwait City, Kuwait, where Blinken is wrapping up an overseas trip.

State Department spokesman Ned Price said Blinken told Tedros that any follow-up probe into the COVID-19 outbreak must be “be timely, evidence-based, transparent, expert-led, and free from interference.”

Blinken also stressed the importance of international unity in order to understand the pandemic and to prevent future ones, Price said in a statement. He added that Blinken and Tedros had both committed to work together with all members of the WHO to “make meaningful, concrete progress in strengthening global health security to prevent, detect, and respond to future pandemics and health threats.”

The meeting, which had not been previously announced, came after China rejected WHO calls for a second investigation into the virus.


SAN JUAN, Puerto Rico — Puerto Rico’s governor announced Wednesday that all public employees must be vaccinated against the coronavirus starting next month as the U.S. territory reports a new rise in cases.

The executive order goes into effect Aug. 16 with few exceptions. Those who refuse to get inoculated will be required to submit a negative virus test weekly. If an employee refuses to get tested, they will be forced to use their vacation days and eventually may not be paid, Gov. Pedro Pierluisi said.

“To finish defeating the pandemic, this is the step to follow,” he said. “Vaccination is the solution.”

Some 27,000 government employees are affected by the order, which comes a day after Pierluisi ordered that masks once again be worn indoors.

The island of 3.3 million people has reported more than 124,000 confirmed coronavirus cases and more than 2,500 deaths related to COVID-19. More than 76% of the population has received at least a first vaccine dose.

Nanjing, a city of 9.3 million people northwest of Shanghai, ordered tens of thousands of people to stay home. It’s conducting mass testing while experts hunt for the source of the virus.

China has reported 92,811 confirmed cases and 4,363 deaths.


NAIROBI, Kenya — The World Health Organization’s Africa director says the continent of 1.3 billion people is entering an “encouraging phase after a bleak June” as supplies of COVID-19 vaccines increase.

But Matshidiso Moeti told reporters on Thursday that just 10% of the doses needed to vaccinate 30% of Africa’s population by the end of 2021 have arrived. Some 82 million doses have gotten to Africa so far, while some 820 million are needed.

And the year-end vaccination target is just half the 60% population coverage that African health officials seek to achieve so-called herd immunity. The African continent is far behind on vaccinations as richer countries keep doses for their citizens.

Less than 2% of Africa’s population has been fully vaccinated, and the more infectious delta variant is driving a deadly resurgence of cases. The WHO says nearly 4 million vaccine doses arrived in Africa last week from the global COVAX facility, compared to less than 250,000 in all of June.

Advertisement. Scroll to continue reading.

“There’s a light at the end of the tunnel on vaccine deliveries to Africa but it must not be snuffed out again,” Moeti said. She warned that countries’ decisions to provide a third, “booster” dose could influence decisions on sending vaccines to Africa.

Africa Centers for Disease Control director John Nkengasong told reporters that African countries might need more doses than previously thought as the delta variant spreads and younger people get COVID-19.


TOKYO — Japanese officials have sounded the alarm as Tokyo reported record-breaking coronavirus cases for the third straight day with the Olympics well underway.

Chief Cabinet Secretary Katunobu Kato told reporters the new cases are soaring not only in the Tokyo area but across the country. He says Japan has never experienced an expansion of infections of this magnitude.

Tokyo reported 3,865 new cases on Thursday, up from 3,177 on Wednesday and double the number it had a a week ago,

Japan has kept its cases and deaths lower than many other countries, but its seven-day rolling average is growing and now stands at 28 per 100,000 people nationwide and 88 in Tokyo, according to the Health Ministry.

People are still roaming the streets despite stay-at-home requests, making restrictions ineffective. The Tokyo governor says cases could hit 4,500 a day.

“While almost nothing is helping to slow the infections, there are many factors that can accelerate them,” said Dr. Shigeru Omi, a top government medical adviser, noting the Olympics and summer vacation. “The biggest risk is the lack of a sense of crisis.”


MADRID — Spain’s prime minister on Thursday announced that existing measures to protect the most vulnerable from the pandemic’s economic fallout will be prolonged until the end of October.

Spain, one of the country’s that was hardest hit at the beginning of the health emergency, has extended subsidies for the unemployed and furloughs for companies that have gone out of business to try to cushion an economic drop of 11% of its gross domestic product in 2020.

As a national lockdown extended in March last year, the government also rolled out a series of social measures, including a ban on leaving impoverished families without utilities and a moratorium on forced evictions for those who saw their income vanish.

During a televised briefing on Thursday to summarize progress during the first 1½ years of his left-wing coalition, Prime Minister Pedro Sánchez said that the so-called social shield will be extended beyond the current Aug. 9 expiration date to Oct. 31.

The change will be approved by the Cabinet next week, Sánchez said.

New cases have spread mostly among people under 30, who largely haven’t received their vaccine shots yet, although the speed of infections spreading has plateaued in recent days.


TUNIS, Tunisia — Tunisia’s president has ordered the creation of a special body to manage the country’s coronavirus crisis amid raging infections and public anger over the government’s handling of the pandemic.

Advertisement. Scroll to continue reading.

President Kais Saied made the announcement Wednesday, according to Tunisian media, saying the new virus operation would be run by the military health service and tasked with ensuring the enforcement of virus restrictions, managing medical stocks and coordinating national virus strategy.

Saied suspended parliament, fired the prime minister and took over all executive powers earlier this week after nationwide protests over Tunisia’s long-running economic crisis and the government’s management of the virus.

Tunisia has the highest virus death rate in Africa and has faced its worst COVID-19 outbreaks to date in recent weeks, with thousands of cases and more than 100 deaths daily in a country of 11 million, according to data from the government and John’s Hopkins University.


NAIROBI, Kenya — Burundi’s government now says it will accept COVID-19 vaccines, becoming one of the last countries in the world to embrace them. But the health ministry says it will not take responsibility for any side effects they might cause.

Health Minister Thaddee Ndikumana on Wednesday said the vaccines will arrive with the support of the World Bank. It was not immediately clear how many doses the East African country will receive or when.

“The vaccine will be given to those who need it,” the health minister said. The government will store the doses but will not take responsibility for any side effects, he added.

Burundi’s announcement came the same day that neighboring Tanzania launched its vaccination campaign, retreating from former President John Magufuli’s denial of the pandemic. He died in March and the presidency went to his deputy Samia Suluhu Hassan, who has since reversed course on COVID-19 in one of Africa’s most populous countries.

Burundi’s late President Pierre Nkurunziza, who died last year, also was criticized for taking the pandemic lightly. The administration of his successor, President Evariste Ndayishimiye, earlier this year said the country of more than 11 million people didn’t yet need COVID-19 vaccines.


BANGKOK — Health authorities in Thailand are racing to set up a large field hospital in a cargo building at one of Bangkok’s airports as the country reports record numbers of coronavirus cases and deaths.

Other field hospitals are already in use in the capital after it ran out of hospital facilities for thousands of infected residents. Workers rushed to finish the 1,800-bed hospital at Don Mueang International Airport, where beds made from cardboard box materials are laid out with mattresses and pillows.

The airport has had little use because almost all domestic flights were canceled two weeks ago. The field hospital is expected to be ready for patients in two weeks.

The airport, a domestic and regional hub, has had little use because almost all domestic flights were canceled two weeks ago.

The quick spread of the delta variant also led neighboring Cambodia to seal its border with Thailand on Thursday and order a lockdown and movement restrictions in eight provinces.


VILNIUS, Lithuania — The Lithuanian government says it will donate 20,000 doses of the AstraZeneca coronavirus vaccine to Taiwan.

The Baltic country’s Health Ministry said Thursday that the donation “is a gift to the people of Taiwan to help to deal with insidious coronavirus infections. We feel an obligation to help other nations who need these jabs”.

Advertisement. Scroll to continue reading.

Lithuania, a country of slightly less than 3 million, donated 20,000 vaccines each to other European countries — Armenia, Georgia, Moldova and Ukraine — earlier this year.

More than half of Lithuania’s population is either vaccinated or has recovered from COVID-19, although the infection rate has grown in recent weeks.

Lithuania’s 14-day coronavirus infection rate has now reached 91 cases per 100,000 persons.


MANILA, Philippines — Philippine President Rodrigo Duterte is warning that Filipinos who refuse to get vaccinated against the coronavirus will not be allowed to leave their homes as a safeguard against the more contagious delta variant.

Duterte said in televised remarks Wednesday night that there is no law mandating such a restriction but added he is ready to face lawsuits to keep people who are “throwing viruses left and right” off the streets.

The brash-talking president adds that for people who don’t want to be vaccinated, “well, for all I care, you can die anytime.”

However, more than public hesitance, the Philippines has been grappling with vaccine shortages.

Nearly 7 million Filipinos have been fully vaccinated and more than 11 million others have received their first dose. That is a fraction of the government’s target of 60 million to 70 million people.


CHICAGO — The hordes of people expected to descend on Chicago’s Grant Park for the Lollapalooza music festival this week will be required to show proof that they’ve been vaccinated for COVID-19 or tested negative for the disease within the last three days.

The four-day festival starts Thursday and is expected to be back at full capacity, with roughly 100,000 daily attendees. After missing last summer because of the threat of the coronavirus, it will easily be Chicago’s largest gathering since the pandemic started, and one of the country’s.

This year’s festival will look very different than in the past. To gain entry, attendees will have to present their vaccination cards or a printed copy of a negative COVID-19 test that is no more than 72 hours old. That means that anyone with a four-day pass who isn’t vaccinated will have to get tested twice. Furthermore, anyone who isn’t vaccinated will have to wear a mask.

Public health officials and others have raised concerns that such a large gathering, even outdoors, risks turning into a super-spreader event. Officials in the Netherlands were shocked after a much smaller music festival attended by 20,000 people over two days early this month led to nearly 1,000 cases of COVID-19, CNBC reported. That festival had similar safeguards to Lollapalooza’s.


WASHINGTON – The State Department says Secretary of State Antony Blinken has met the head of the World Health Organization to press for additional studies into the origin of the coronavirus pandemic in China.

Blinken and WHO Director General Tedros Ghebreyesus met Wednesday in Kuwait City, Kuwait, where Blinken is wrapping up an overseas trip.

State Department spokesman Ned Price said Blinken told Tedros that any follow-up probe into the COVID-19 outbreak must be “be timely, evidence-based, transparent, expert-led, and free from interference.”

Advertisement. Scroll to continue reading.

Blinken also stressed the importance of international unity in order to understand the pandemic and to prevent future ones, Price said in a statement. He added that Blinken and Tedros had both committed to work together with all members of the WHO to “make meaningful, concrete progress in strengthening global health security to prevent, detect, and respond to future pandemics and health threats.”

The meeting, which had not been previously announced, came after China rejected WHO calls for a second investigation into the virus.


SAN JUAN, Puerto Rico — Puerto Rico’s governor announced Wednesday that all public employees must be vaccinated against the coronavirus starting next month as the U.S. territory reports a new rise in cases.

The executive order goes into effect Aug. 16 with few exceptions. Those who refuse to get inoculated will be required to submit a negative virus test weekly. If an employee refuses to get tested, they will be forced to use their vacation days and eventually may not be paid, Gov. Pedro Pierluisi said.

“To finish defeating the pandemic, this is the step to follow,” he said. “Vaccination is the solution.”

Some 27,000 government employees are affected by the order, which comes a day after Pierluisi ordered that masks once again be worn indoors.

The island of 3.3 million people has reported more than 124,000 confirmed coronavirus cases and more than 2,500 deaths related to COVID-19. More than 76% of the population has received at least a first vaccine dose.


Copyright 2020 Associated Press. All rights reserved.

Source: https://apnews.com/article/entertainment-africa-business-music-health-dcf51acfe48faff12b92b1d26d8dcd01

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