Infectious Disease

The FDA will evaluation Johnson & Johnson’s one-of-a-kind vaccine that “may very well be a recreation changer”.

February 05, 2021

2 min read

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Clancy and Fauci do not report any relevant financial information.

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Johnson & Johnson has filed with the FDA for emergency approval for its one-off COVID-19 vaccine, which experts say could help change the course of the pandemic.

The FDA will not decide on Emergency Use (EEA) approval until after a meeting of the Independent Advisory Committee on Vaccines and Related Biological Products on Feb.26.

Covid vaccination

The Johnson & Johnson vaccine is given in one dose.
Photo credit: Adobe Stock

Meanwhile, the FDA said it would “thoroughly evaluate the data and information submitted in the EEA request prior to the meeting and be prepared for a solid public discussion with members of the advisory committee.”

In a Phase 3 study conducted in eight countries, the vaccine was 85% effective in preventing serious illnesses and 66% effective in preventing moderate to serious illnesses, the company said last week. The efficacy was reported as 72% in the USA, 66% in Latin America and 57% in South Africa, with 95% of the COVID-19 cases occurring during the trial originating from the B.1.351 variant of SARS-CoV-. 2 that has raised some concerns about its ability to evade vaccines or treatments.

Cornelius J. Clancy

This variant was first reported in the United States last week. Other variants – including one that was first identified in the UK – are also floating around and may make the country’s response to the virus difficult.

The approval of the Johnson & Johnson vaccine would give the country a third option for COVID-19 vaccination, and one where a vaccine doesn’t have to come back for a second dose weeks later.

“This could be a game changer in the fight against COVID-19,” he said. Cornelius (Neil) J. Clancy, MD, said Healio, associate professor of medicine and director of the Comprehensive Drug Resistant Pathogen Laboratory and Mycology Program at the University of Pittsburgh.

As of February 4, nearly 57.5 million doses of the messenger RNA-based vaccines from Pfizer-BioNTech and Moderna had been distributed in the US, and nearly 28 million people had received at least one dose, according to the CDC Other tracking projects put together suggest that the US may be further advanced.

The Johnson & Johnson shot – a recombinant vector vaccine that uses a modified human adenovirus – has another benefit along with experts, experts have found. Unlike some other vaccines that require extremely cold storage, it can be stored at a normal refrigerated temperature of 36 ° F to 46 ° F for at least 3 months.

Last year director of the National Institute for Allergies and Infectious Diseases Anthony S. Fauci, MD, said the vaccine “can be particularly useful in fighting the pandemic if it is found to be protective after a single dose.”

“An effective single-dose vaccine without the logistical challenges posed by Pfizer and Moderna vaccines promises to significantly accelerate the pace of vaccination at the national level,” said Clancy, although he acknowledged the pace of available supply of Johnson & Johnson Johnson depends on vaccine.

Johnson & Johnson expects to ship 100 million doses “in the first half of the year,” but a report by the US Government Accountability Office said in a report by Bloomberg last week that only about 2 million doses would be released to agents after an EEA was issued from Janssen Pharmaceuticals, the subsidiary of Johnson & Johnson that developed the vaccine.

“Coupled with the dramatic decline in newly diagnosed cases in the US over the past few weeks, the prospects for a more normal summer than the previous one look better than it was earlier this year,” said Clancy. “We need to track the emergence of SARS-CoV-2 variants over the coming weeks and months and understand what they mean for vaccine effectiveness and societal immunity. At the moment, however, this news is very welcome. “

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