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Johnson & Johnson COVID-19 Vaccine Under Further Scrutiny in US

Exterior view of the European Medicines Agency, EMA, in Amsterdam's business district, Netherlands, Tuesday, April 20, 2021. Experts at the European Medicines Agency are preparing to present the conclusions of their investigation later on Tuesday…

Johnson & Johnson’s COVID-19 vaccine is coming under further scrutiny by U.S. government health authorities.

Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention (CDC), said Monday the agency was looking into reports of additional cases of severe side effects possibly linked to the one-shot vaccine.

Walensky told reporters during a White House news briefing the agency is “encouraged that it hasn’t been an overwhelming number of cases, but we are looking and seeing what’s come in.”

The CDC and the U.S. Food and Drug Administration (FDA) jointly called for a pause in the administration of the Johnson & Johnson vaccine last week after six women between the ages of 18 and 48 developed a rare but serious blood-clotting disorder following vaccination. One woman died and one was hospitalized in critical condition.

The six women were among the 7 million Americans who have received the vaccine since its approval.

The Johnson & Johnson vaccine makes up a small proportion of the U.S. vaccine supply, but experts say the problem may make more people reluctant to get vaccinated. Dr. Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, has said he expects an independent CDC advisory panel to lift the suspension when it meets again later this week.

In a related matter, Emergent BioSolutions, a Baltimore-based manufacturing plant that ruined millions of doses of the Johnson & Johnson COVID-19 vaccine, said Monday it has temporarily suspended operation at the request of the FDA after an agency inspection last week. Workers at the Emergent plant mixed the Johnson & Johnson vaccine with ingredients from the coronavirus vaccine developed by AstraZeneca, rendering 15 million doses of the Johnson & Johnson vaccine useless.

Researchers at the University of Oxford in Britain have launched a “human challenge” clinical trial to investigate the body’s immune response to a second COVID-19 infection. The trial is broken up in two stages, with the first stage involving as many as 64 volunteers between 18 and 30 years old who have completely recovered from the virus. Researchers will re-expose about half of the participants to the lowest dose of the disease in carefully controlled conditions.

The researchers will then expose all of the participants in the next stage with a standard dose of the coronavirus that was set up during stage one.

The clinical trial could accelerate development of new and better COVID-19 treatments and vaccines.

As of Tuesday, more than 142.1 million people around the globe have been infected by COVID-19, including over 3 million deaths, according to Johns Hopkins Coronavirus Resource Center.

The number of new cases around the world are on the rise despite the acceleration of vaccination campaigns in many nations, especially in India, which reported 259,170 new COVID-19 cases on Tuesday, its sixth consecutive day of more than 200,000 confirmed new infections. The government also reported 1,761 coronavirus deaths Tuesday, its highest daily fatality rate in several months.

The latest surge has led to a severe shortage of oxygen canisters, hospital beds and drugs, and prompted officials in the capital, New Delhi, to impose a weeklong lockdown on Monday.

With more than 15 million total infections, India is second to the United States, which has recorded 31.6 million cases.

Former Indian Prime Minister Manmohan Singh, 88, was hospitalized Monday in New Delhi after testing positive for COVID-19.

Just more than 1% of India's population has been vaccinated, according to Johns Hopkins.

Indian officials announced Monday that everyone 18 or older will be eligible to receive a vaccine beginning May 1.

The growing surge of new COVID-19 cases around the world has prompted the U.S. State Department on Monday to announce an increase in the number of countries on its “Do Not Travel” list by around 80 %.

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