Johnson & Johnson’s COVID-19 vaccine remained in limbo on Wednesday as a U.S. health panel called for more data before deciding how and whether to resume use of the one-dose shot, putting off a vote for a week or more.The U.S. Centers for Disease Control and Prevention (CDC) advisory panel decided to delay a vote on how best to use the J&J shot even after a U.S. Food and Drug Administration (FDA) scientist told advisers he believed warnings could mitigate the risk of extremely rare but serious blood clots.The panel is reviewing six reported cases of rare brain blood clots in women who received the J&J vaccine, a day after the FDA and CDC jointly recommended pausing its use to assess the issue.Dr. Lynn Batha, an epidemiologist at the Minnesota health department, and several others spoke in favor of extending the pause to gather more safety information.”By having more robust information, I think we can be more confident about how we talk about the safety of this vaccine,” she told other members of the advisory panel.Earlier, the FDA’s deputy director for vaccine development, Doran Fink, told the panel that his current thinking was that warning statements and communications from the federal agency would allow doctors to weigh risks and benefits of the vaccine.Other panel members and advisers, however, expressed concern that extending the pause could worsen issues related to equitable access to the vaccine, which is seen as important for serving hard-to-reach communities because it can be stored at normal refrigerator temperatures and given as one dose instead of two.Women knit while waiting for their shot of the AstraZeneca vaccine for COVID-19 at a government-run social security clinic during vaccinations for people older than 80 in La Paz, Bolivia, April 14, 2021.”Any extension of the pause will invariably result in the fact that the most vulnerable individuals in the United States will remain vulnerable,” Nirav Shah, director of the Maine Center for Disease Control and Prevention and a representative of the Association of State and Territorial Health Officials, told the panel. Shah is not a voting member.Several panel members wanted to vote to extend the pause by as much as a month, but Dr. Beth Bell, a global health expert at the University of Washington, argued that would send a signal globally of a major issue with the vaccine.”I don’t want to send the message that there is something fundamentally wrong with this vaccine, which I don’t agree with,” she said.”It’s a very rare event,” Bell said of the cases of blood clots in the brain, known as cerebral venous sinus thrombosis (CVST), along with low blood platelets. “Nothing is risk-free.”The six cases, all in women under age 50, were reported out of 7.2 million doses of the J&J vaccine administered in the United States — a risk federal health officials and immunology experts said was extremely low, especially when weighed against the potential ravages of COVID-19.One of the six women died and three remain hospitalized. So far, more than 562,000 people in the United States have died from COVID-19.Bell argued in favor of postponing a vote and gathering more information, which the panel decided to do.The FDA is charged with weighing evidence on a vaccine’s safety and effectiveness and could add warnings to existing labeling. The panel’s role is to advise public health officials and the CDC director on how best to use vaccines once they are approved.The panel could recommend limiting the use of the vaccine to specific age groups to reduce risks and is likely to issue advice to health care providers on how to recognize concerning symptoms and treat those patients.One of the standard treatments for blood clots, heparin, could lead to serious complications or death with this rare clotting condition.Johnson & Johnson has not seen CVST in recipients of its Ebola vaccine or its vaccine against respiratory syncytial virus, which use similar technology, or in its ongoing trial of a two-dose regimen of the COVID-19 vaccine, according to a company presentation to the vaccine advisory panel.The group of outside advisers will decide by Friday on when it will reconvene, which could be within a week to 10 days, CDC officials said.
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Day: April 14, 2021
South African mobile communications company Vodacom South Africa, with British parent company Vodafone and charity Hestia, has launched a free mobile phone application to support targets of gender-based violence, which has soared during the coronavirus pandemic. The application, “Bright Sky,” provides information for people to identify gender-based violence and get counseling and emergency help. Franco Puglisi reports from Johannesburg.Producer: Rod James. Camera: Franco Puglisi.
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Predicting whether an outbreak is likely to happen is now possible with the COVID-19 Outbreak Detection Tool, a map that shows the coming hotspots for the disease, if accurate data is available. VOA’s Elizabeth Lee has the details.Producer: Elizabeth Lee
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Kurdish officials in northeast Syria are expressing concerns over a sharp increase in coronavirus cases in their region, calling on international health organizations to intervene to prevent a “humanitarian catastrophe.”
A 10-day curfew went into effect Tuesday in an attempt to curb the spread of the deadly virus in the semiautonomous region, which is home to nearly 5 million people, including thousands of internally displaced people, refugees and prisoners of the Islamic State (IS) terror group, also known as ISIS or its Arabic acronym, Daesh.
“The situation is getting out of control,” said Jowan Mustafa, co-chair of the Health Department at the Autonomous Administration in North and East Syria (AANES), a governing body affiliated with the U.S.-backed Syrian Democratic Forces (SDF).
“In the past few weeks, we have witnessed a growing rate of COVID-19 cases in our region,” he told VOA by phone. “We need immediate assistance from international health organizations to stop a potential humanitarian catastrophe.”
On Wednesday alone, 248 new cases and five deaths were reported, bringing the total number of coronavirus infections in northeast Syria to 13,004, including 437 deaths.
Local health officials said the actual number of those infected with the virus could be much higher.
“Our testing capacity is very limited, and our hospitals and health facilities are overwhelmed,” said Mustafa, adding that “many people carrying the virus are staying at home without reporting to us.”
Al-Hol camp
One in four COVID-19-related deaths confirmed on Tuesday occurred in al-Hol camp, where over 60,000 people reside, including thousands of families of IS foreign fighters.
Sheikhmous Ahmed, head of the Refugee Affairs Office at the AANES, said overpopulation and poor health infrastructure make camp residents more susceptible to the coronavirus, also known as SARS-CoV-2, the viral strain that causes COVID-19.
“Given the current high number of COVID cases outside the camp, its spread could be much more rapid inside the camp,” Ahmed told VOA.
He said medical teams at al-Hol don’t have enough resources to contain a sudden outbreak of the virus.FILE – A member of Kurdish internal security stands guard at the Kurdish-run al-Hol camp, in northeastern Syria, Jan. 28, 2021.Philippe Nassif, Middle East and North Africa advocacy director at Amnesty International, said “in Syria, where over half the population has been displaced and tens of thousands remain in IDP camps in the northeast, the pandemic has taken a particularly heavy toll.”
“This includes prisons holding ISIS fighters, their families and other detainees creating a crisis within a crisis,” he said.
In addition to those held in al-Hol and other detention camps, the SDF says it holds more than 10,000 IS fighters, including about 2,000 foreign nationals.
“Amnesty International has profound concerns for the well-being of those held in detention, and for the hundreds of thousands of refugees and IDPs scattered across Syria and the region,” Nassif told VOA. “The world needs an urgent plan to help these vulnerable populations get vaccinated immediately.”
Call for help
Mustafa of AANES said the organization has reached out to international health bodies, including the World Health Organization, to take immediate action in this part of the war-ravaged country.
“The WHO has said it would deliver a small number of vaccines to northeast Syria in April, but even that hasn’t happened yet,” he said, noting that “if we don’t receive immediate assistance from the WHO, then other non-governmental health groups should step in to help us stop this crisis.”
WHO said last month it will run a coronavirus vaccination campaign in Syria, with the goal of inoculating 20% of the country’s population by the end of 2021.
WHO representative to Syria Akjemal Magtymova recently said only one of 16 public hospitals in the region is fully functioning, and three are partially functioning.
“It is a massive challenge to ensure the adequate number of hospital beds in intensive care units, in the wake of the third wave of COVID-19 in Syria,” she said in a statement, noting that “access to COVID-19 vaccines to reduce ongoing transmission is yet another mammoth task for Syria.”
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South Africa’s health minister says the nation will still hit its COVID-19 vaccination targets, even as it pauses the use of the Johnson & Johnson shot amid concerns over blood clots. South Africa’s mass-inoculation campaign was dealt the setback following word that six women in the United States developed a blood clotting disorder after receiving the one-shot Johnson & Johnson vaccine. One person died. Nearly 7 million doses have been administered in the United States. This is now the second time that South Africa has had to shift gears in its vaccination campaign. In February, just days after receiving its first shipment of vaccines, authorities jettisoned plans to use the AstraZeneca product amid reports that it did not protect against the variant of the coronavirus that is most prevalent in South Africa. The coronavirus causes the COVID-19 respiratory disease. And now this, said Dr. Zweli Mkhize, the nation’s health minister. So far, he said, more than 290,000 South African health workers have been given the vaccine, with no reported blood clots. Nevertheless, he told officials, South Africa will pause the program until everyone is sure the vaccine is safe. As COVID-19 Epicenter, South Africa to Receive 41 Million Vaccine DosesSouth Africa lauds arrival of tens of millions of doses; announces alcohol ban over major holiday weekend “Based on their advice, we’ve determined to voluntarily suspend our rollout until the causal relationship between the development of clots and the Johnson & Johnson vaccine is sufficiently interrogated,” he said to parliamentarians via webinar on Wednesday. “… I call for calm and patience as we ensure that we continue to be properly guided by science and ensuring the safety of our people as we roll out the vaccine campaign.” Mkhize says he hopes deliberations on the Johnson & Johnson vaccine’s safety will last only a few days and will not lead to complete withdrawal of the product. He says the news about the vaccine is disappointing as mortality rates from the coronavirus appear to be declining, and South Africa will soon receive a total of 30 million doses of the two-shot Pfizer vaccine. South Africa has more than 1.5 million confirmed cases, giving it the highest burden on the continent. But, he said, the bigger battle — the one he hasn’t been able to discuss until now — is the behind-the-scenes fight South African officials have waged with pharmaceutical giants. Both Johnson & Johnson and Pfizer, he said, have asked for what he described as “difficult and unreasonable” guarantees from South Africa and other nations. “I can also assure you that we have not been sleeping on the job,” he said. “The fact that we previously did not disclose before parliament the blow-by-blow details of the intense negotiations is because we’re prioritizing the closing of those agreements in order to secure the vaccines we require for us to reach population immunity.”
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Hours after U.S. federal health officials urged a pause in the use of Johnson & Johnson’s COVID-19 vaccine after it was linked to a rare but dangerous blood clot, the U.S. pharmaceutical giant announced Tuesday it was delaying rollout of the single-dose vaccine in Europe.“We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public,” the company said in a written statement.Syringes with AstraZeneca coronavirus disease (COVID-19) vaccines are prepared in Fasano, Italy, Apr. 13, 2021.The delay strikes a major blow to Europe’s already sluggish vaccination efforts, which has been plagued by logistical problems and a shortage of vaccines. The continent’s vaccination campaign has also been hindered by the troubled rollout of the vaccine developed by British-Swedish drugmaker AstraZeneca and the University of Oxford, which has also been linked to cases of rare blood clots.The U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) said six women between 18 and 48 years of age who had received the Johnson & Johnson vaccine developed blood clotting known as cerebral venous sinus thrombosis (CVST) within six to 13 days after being inoculated. One of the women died, while another has been hospitalized in critical condition.Dr. Jane Woodcock, the acting commissioner of the F.D.A., told reporters Tuesday during a joint virtual briefing the pause is expected to last only “a matter of days” as both agencies investigate the matter. The CDC is holding an emergency meeting of its Advisory Committee on Immunization Practices on Wednesday to review the cases.CDC Principal Deputy Director Anne Schuchat said people who received the vaccine more than two weeks ago have very little to fear. Those who received the vaccine within the last week or so who develop symptoms such as severe headache, abdominal or leg pain, or shortness of breath, should contact their health care provider.They note the six cases occurred out of more than 6.8 million doses of the vaccine administered.FILE — In this Feb, 17 2021 file photo, health care workers look through a window at a hospital in Khayelitsha, Cape Town, South Africa during the rollout of the first batch of Johnson and Johnson vaccines in the country.South Africa also followed suit Tuesday by suspending use of Johnson & Johnson COVID-19 vaccine.Both the Johnson & Johnson and AstraZeneca vaccines were developed using so-called adenoviruses to carry DNA into human cells that generates the body’s immune system to ward off the coronavirus.Better news on the COVID-19 vaccine front came Tuesday from Moderna. The U.S.-based pharmaceutical company said data from its late-stage clinical trials shows its two-dose vaccine is more than 90% effective against a coronavirus infection, and 95% effective against severe disease up to six months after the second dose. Moderna is currently testing its vaccine among young people between 12 to 17 years of age.A new study conducted by U.S.-based health care provider Kaiser Permanente found that a lack of physical activity poses a greater risk of severe COVID-19 infection and death. The study, published Tuesday in the British Journal of Sports Medicine, covered nearly 50,000 people in the United States who had been diagnosed with the coronavirus. The researchers say those physically inactive for at least two years before the pandemic were twice as likely to be hospitalized as those who engaged in regular exercise.Scientists say the previous risk factors for severe COVID-19 infection includes advanced age, being male and having such pre-existing conditions such as diabetes, obesity or cardiovascular disease.
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European Commission President Urusula Von der Leyen Wednesday announced the European Union has reached a deal with pharmaceutical partners Pfizer-BioNTech for 50 million additional doses of COVID-19 vaccine, to be delivered in the coming months.
At a news briefing in Brussels, Von der Leyen said the new deal means the EU will have obtained 250 million doses. She said the bloc is negotiating a third contract with the partners for 1.8 billion doses to be delivered in 2022 and 2023.
She said the deal will “not only include the production of vaccines, but also the essential components. All of that will be based in the European Union.”
Von der Leyen said 100 million doses have been administered in the 27-nation EU bloc already, saying this is “a milestone we can be proud of.”
But, noting issues with AstraZeneca, and this week, the Johnson & Johnson shots, the European Commission president said many factors can disrupt the planned delivery schedules of vaccines.
She said, “It is therefore important to act swiftly, anticipate, and adjust whenever it is possible, and we are doing everything in our power to support Europe’s vaccination rollout.”
Several European nations suspended administering the AstraZeneca vaccine after reports of rare cases of blood clots. Tuesday, U.S. health regulators recommended pausing inoculations with Johnson & Johnson’s product because of similar reports.
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Hours after U.S. federal health officials urged a pause in the use of Johnson & Johnson’s COVID-19 vaccine after it was linked to a rare but dangerous blood clot, the U.S. pharmaceutical giant announced Tuesday it was delaying rollout of the single-dose vaccine in Europe.“We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public,” the company said in a written statement.Syringes with AstraZeneca coronavirus disease (COVID-19) vaccines are prepared in Fasano, Italy, Apr. 13, 2021.The delay strikes a major blow to Europe’s already sluggish vaccination efforts, which has been plagued by logistical problems and a shortage of vaccines. The continent’s vaccination campaign has also been hindered by the troubled rollout of the vaccine developed by British-Swedish drugmaker AstraZeneca and the University of Oxford, which has also been linked to cases of rare blood clots.The U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) said six women between 18 and 48 years of age who had received the Johnson & Johnson vaccine developed blood clotting known as cerebral venous sinus thrombosis (CVST) within six to 13 days after being inoculated. One of the women died, while another has been hospitalized in critical condition.Dr. Jane Woodcock, the acting commissioner of the F.D.A., told reporters Tuesday during a joint virtual briefing the pause is expected to last only “a matter of days” as both agencies investigate the matter. The CDC is holding an emergency meeting of its Advisory Committee on Immunization Practices on Wednesday to review the cases.CDC Principal Deputy Director Anne Schuchat said people who received the vaccine more than two weeks ago have very little to fear. Those who received the vaccine within the last week or so who develop symptoms such as severe headache, abdominal or leg pain, or shortness of breath, should contact their health care provider.They note the six cases occurred out of more than 6.8 million doses of the vaccine administered.FILE — In this Feb, 17 2021 file photo, health care workers look through a window at a hospital in Khayelitsha, Cape Town, South Africa during the rollout of the first batch of Johnson and Johnson vaccines in the country.South Africa also followed suit Tuesday by suspending use of Johnson & Johnson COVID-19 vaccine.Both the Johnson & Johnson and AstraZeneca vaccines were developed using so-called adenoviruses to carry DNA into human cells that generates the body’s immune system to ward off the coronavirus.Better news on the COVID-19 vaccine front came Tuesday from Moderna. The U.S.-based pharmaceutical company said data from its late-stage clinical trials shows its two-dose vaccine is more than 90% effective against a coronavirus infection, and 95% effective against severe disease up to six months after the second dose. Moderna is currently testing its vaccine among young people between 12 to 17 years of age.A new study conducted by U.S.-based health care provider Kaiser Permanente found that a lack of physical activity poses a greater risk of severe COVID-19 infection and death. The study, published Tuesday in the British Journal of Sports Medicine, covered nearly 50,000 people in the United States who had been diagnosed with the coronavirus. The researchers say those physically inactive for at least two years before the pandemic were twice as likely to be hospitalized as those who engaged in regular exercise.Scientists say the previous risk factors for severe COVID-19 infection includes advanced age, being male and having such pre-existing conditions such as diabetes, obesity or cardiovascular disease.
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The U.N. Population Fund called on nations Wednesday to respect bodily autonomy as a universal right, saying too many women and girls are denied this basic power over their own bodies.“The right to autonomy over our bodies means that we must have the power and agency to make choices without fear of violence or having someone else decide for us,” UNFPA Executive Director Natalia Kanem told reporters.Natalia Kanem, executive director of the United Nations Population Fund, gives a press conference in the Yemeni capital Sanaa on March 22, 2021.Those other decision-makers include partners, family members, society and government.In a new report, “My Body is My Own,” UNFPA reviewed data from nearly 60 countries, representing about a quarter of the world’s population. It found that nearly half of the women lack the power to make their own decisions about their health care, whether or not to use contraception, or to have sexual intercourse with a partner.“A woman who has control over her body is more likely to have power in other spheres of her life,” Kanem said.
But when they are denied this power, she said it reinforces inequalities and perpetuates violence arising from gender discrimination, which is at the root of the problem.“When control rests elsewhere, autonomy remains perpetually out of reach,” the report notes.Crimes and practices that violate a woman’s bodily autonomy include “honor” killings, forced and early marriage, “virginity” tests and female genital mutilation. Forced pregnancy or abortion also violate a woman’s power to make decisions concerning her body.“Some violations, such as rape, may be criminalized, but then not always prosecuted and punished,” Kanem said. “Other violations go unchallenged altogether because they are reinforced by community norms, practices and laws.”Despite constitutional guarantees of gender equality in many countries, the report says on average, women globally enjoy only 75% of the legal rights of men.Kanem said COVID-19 has worsened the situation for millions of women, increasing sexual violence, especially during lockdowns, creating new barriers to access to health care, and job and education losses.The report notes that bodily autonomy is an issue for other often marginalized groups, including unmarried women, LGBTI communities and persons with disabilities.No country has achieved total gender equality, but among those with the best track record are Sweden, Uruguay, Cambodia, Finland and Netherlands.“A diversity that shows you that this aspirational value doesn’t really depend on culture or location,” Kanem said, noting that the same is true at the bottom of the scale.She said governments have a lead role to play by fulfilling obligations under human rights treaties and altering social, political, institutional and economic structures that reinforce gender inequalities.
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Several U.S. states have temporarily stopped providing Johnson & Johnson coronavirus vaccines in line with federal guidance after six people who received the shots developed rare blood clots. Meanwhile, several countries have suspended the AstraZeneca vaccines after reports it, too, may be linked to blood clots. White House correspondent Patsy Widakuswara reports.
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