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FDA, CDC Urge Pause in J&J COVID-19 Vaccination, Citing "Rare" Blood Clots


The FDA and U.S. Centers for Disease Control and Prevention (CDC) are recommending that U.S. states pause their administration of Johnson & Johnson’s Janssen COVID-19 Vaccine Candidate while they review six reported cases of patients developing what they termed rare and severe blood clots after receiving the vaccine.
The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet Wednesday to review the cases and assess their potential significance. The FDA also plans to investigate those cases, and will review the CDC’s analysis, the agencies said this morning in a joint statement.
“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” the agencies said, in a statement by Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, MD, principal deputy director of the CDC and a retired rear admiral with the U.S. Public Health Service. ....

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Another beginning: The Hindu Editorial on the need for vaccine pharmacovigilance as more COVID-19 vaccines come into use


Pharmacovigilance is vital as more vaccines become available and new side-effects seen
As India grapples with a vaccine shortage, the Drug Controller General of India has formally approved another vaccine candidate Sputnik V under emergency use authorisation. Since January, India’s vaccination strategy has hinged almost entirely on Covishield the AstraZeneca vaccine and to a very limited extent, Covaxin. Another significant move by the government is in allowing foreign-made vaccines approved by regulatory agencies in the U.S., the U.K., Europe, Japan or those that find mention in the World Health Organization’s list of approved emergency use vaccines which can avoid conducting a local clinical trial but opt for a parallel bridging trial post-approval. Last year, Pfizer had approached Indian regulators for permission but a sticking point was over this question of the conduct of local trials. It is important to note that bridging trials are critical. A vaccine that ....

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Moderna Starts New COVID-19 Vaccine Trial


Moderna Starts New COVID-19 Vaccine Trial
by Angela Mohan on 
March 17, 2021 at 2:17 PM
First participants have been dosed in the Phase 1 study of mRNA-1283, Moderna s next generation COVID-19 vaccine candidate, which will assess the safety and immunogenicity of mRNA-1283.
We are pleased to begin this Phase 1 study of our next generation COVID-19 vaccine candidate, mRNA-1283, said Stéphane Bancel, Chief Executive Officer of Moderna.
Our investments in our mRNA platform have enabled us to develop this next generation vaccine candidate, which is a potential refrigerator-stable vaccine that could facilitate easier distribution and administration in a wider range of settings, including potentially for developing countries, Bancel added. ....

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