EMA says four serious cases reported, one fatal, and also expands inquiry into AstraZeneca vaccine

Reuters- The EU’s drug regulator is reviewing reports of rare blood clots in four people who received Johnson & Johnson’s Covid-19 vaccine and has expanded its inquiry into AstraZeneca’s shot to include reports of a bleeding condition.

Of the four serious cases of clotting and low platelets, three occurred in the US during the rollout of J&J’s vaccine from its Janssen pharmaceuticals unit, the European Medicines Agency (EMA) said on Friday, adding that one person had died and one case was reported in a clinical trial. It was the first news of EMA’s inquiry into the J&J vaccine.

The EMA has already confirmed possible links between AstraZeneca’s coronavirus vaccine and very rare blood clots in the brain and abdomen.

J&J, which is based in the US, said it was aware of the reports of blood clots possibly related to its Covid vaccine and others, and was working with regulators to assess the data and provide relevant information.

“At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine,” the company said in an emailed statement.

The EMA also said it was not yet clear if there was a link between the two vaccines and the reported conditions, and that its safety committee would decide if regulatory action such as label changes were needed.

Some countries in Europe and Asia have restricted the use of AstraZeneca’s vaccine, Vaxzevria, in younger people after an update by EU and UK regulators this week that found a link between the events and the shot. Regulators have said the benefits of the vaccine outweigh the risks.

J&J’s single-dose vaccine has been approved for EU use but the rollout has yet to begin. It is mainly being used in the US.

The EMA also said five cases of capillary leak syndrome in people who received AstraZeneca’s vaccine were reported.

The condition, in which blood leaks from the smallest of vessels into muscles and body cavities, is characterised by swelling and a drop in blood pressure.


US Not Ready to Share Surplus Vaccine with World

The Biden administration is taking initial steps toward an expanded role in global COVID-19 vaccination efforts, while stopping short of sharing excess doses on a wide scale.

The federal government has been amassing doses, growing its supply into what will likely become a surplus as the rest of the world struggles with shortages.

In fact, the U.S. has purchased enough vaccines to immunize every adult in the country three times over. Aid groups now say it’s past time to start giving away the surplus.

The administration, however, remains hesitant to do so.

The U.S. vaccination campaign has been relatively successful to date, averaging close to 3 million shots administered every day. About a quarter of all adults have been fully vaccinated, and the Biden administration is well on its way to achieving its goal of inoculating 200 million people by the end of April.

But most of the U.S. international support has come in the form of money, with the administration committing $4 billion to the World Health organization-backed COVAX vaccine initiative.

The U.S. is also co-hosting a fundraising campaign for COVAX in the coming days, with the aim of calling on wealthy nations to join the United States and others in providing resources and commitments to accelerate global COVID-19 vaccinations.

In recent days, top financial and diplomatic officials have indicated they are thinking about next steps, and how to balance the humanitarian needs and possible political implications of vaccine diplomacy.

Secretary of State Antony Blinken on Monday said he has been hearing the calls to share doses.

“I know that many countries are asking for the United States to do more, some with growing desperation because of the scope and scale of their COVID emergencies. We hear you. And I promise, we’re moving as fast as possible,” Blinken said.

In response to those calls, he announced the appointment of Gayle Smith as U.S. coordinator for global COVID-19 response and health security.

Smith most recently served as president and CEO of the ONE Campaign, a nonpartisan organization that advocates for ending poverty and preventable disease by 2030.

The ONE Campaign has been pressuring the administration to ship some of its vaccine supply to developing countries.

Late last month, the group joined a coalition of 30 nongovernmental organizations in sending a letter to Biden, urging him to immediately begin to develop a plan to share excess vaccine doses.

“It is estimated that there could be twice as many deaths from COVID-19 if rich countries monopolize the first doses of vaccines instead of making sure they are distributed globally,” the groups wrote.

The hope for advocates is that Smith, who helped lead the Obama administration’s response to the Ebola outbreak in 2014, will play a pivotal role in designing such a program.

In a dig at Russia and China, which have been more than willing to donate vaccines as a way to foster friendly relations, Blinken noted that when the time comes for the U.S. to send doses overseas, the nation “won’t trade shots in arms for political favors. This is about saving lives.”

Treasury Secretary Janet Yellen recently spoke about the role wealthy countries need to play in helping to end the pandemic.

During a speech before the Chicago Council on Global Affairs, Yellen warned that the economic toll of the pandemic will push 150 million people into extreme poverty this year without a substantial increase in support for developing countries.

“Our first task must clearly be stopping the virus by ensuring that vaccinations, testing and therapeutics are available as widely as possible,” she said.

President Biden has so far only committed to providing about 4 million doses of AstraZeneca’s vaccine, which is not yet authorized in the U.S., to Mexico and Canada.

“The president remains committed to playing a constructive role in the global effort to defeat the virus,” White House press secretary Jen Psaki said Friday. “But as we’ve seen, this is an unpredictable virus and his first priority is ensuring the American people are vaccinated, and that means we need to plan for supply.”

Psaki said the administration is planning for contingencies, and cited the recent error at a manufacturing plant producing the Johnson & Johnson vaccine that resulted in 15 million ruined doses. She also said the U.S. needs to plan for vaccinating children and the potential need for booster shots.

Tom Kenyon chief health officer at Project HOPE, a global health organization, said the appointment of Smith, and the remarks by Yellen and Blinken, is a sign the administration will eventually move to start sharing vaccines.

“But I think we have to move beyond the promise, to action,” Kenyon said. “This is a pandemic, and it’s an emergency.”

Kenyon said the U.S. should have already been sending surplus supplies to help other countries protect their health workers.

“This is a public health endeavor, not a diplomatic endeavor alone. We need diplomacy, but we need public health action,” Kenyon said.


UK Begins to Re-Open

  1. Non-essential shops and beauty salons can now open their doors in England and Wales, as Covid rules are eased across the UK
  2. England’s gyms, zoos and hairdressers can also reopen, while restaurants and pubs can welcome customers outside
  3. Some pubs opened just after midnight, while long queues formed outside shops around the country
  4. Pupils are returning to school full time in Scotland and Wales, while Northern Ireland’s “stay-at-home” order is ending
  5. Prime Minister Boris Johnson says people must “behave responsibly” and continue to take steps to “suppress Covid”
  6. More than 32 million people in the UK have now had their first dose of a coronavirus vaccine
  7. A further seven UK deaths within 28 days of a positive Covid test were reported on Sunday, the lowest daily total since 14 September
  8. Elsewhere, China’s top disease control official has said the efficacy of the country’s Covid vaccines is low, in a rare admission of weakness




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April 12 (GMT)