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COVID DATA Sept 18, 2021 INDIA: New Cases: 35,662 Total Cases:3,34,17,390 New Deaths: 281 Total Deaths: 4,44,529 New Tests: 14,48,833 Total Tests: 55,07,80,273 New Vax: 2,15,98,046 Total Vax: 79,42,87,699 Hot Spot States (daily deaths above 10) Karnataka: New Deaths: 18 Total Deaths: 37,573 Kerala: New Deaths: 131 Total Deaths: 23,296 TPR: 18.05% Maharashtra: New Deaths: 67 Total Deaths: 1,38,389 Tamil Nadu: New Deaths: 17 Total Deaths: 35,288 - India Travel Times.Com   [Estd: 1998]       * * *    Travel, More Travel, Travel Means A Million Things     * * *    
FDA likely to issue Emergency Use Authorisation for J&J covid vaccine on Saturday
When the FDA approves Emergency Use Authorisation, J&J vaccine will become the third one to be administerted to the Americans after Pfizer and Moderna. How the J&J vaccine will be a game changer, and the pluses and minuses:-

SINGLE DOSE: The top advantage of J&J vaccine is that it is a single-dose vaccine unlike all other vaccines produced so far

NO COLD STORAGE: J&J does not require ultra cold storage like in the case of Moderna and Pfizer

PREVENTS ASYMPTOMATIC INFECTION: J&J is also majorly claimed to inhibit asymptomatic infection, reducing the chances of transmission to a great extent, apart from preventing the disease in the inoculated.

NO ANAPHYLACTIC REACTION: There were no reported cases of anaphylaxis following vaccination.

NO DEATHS IN TRIALS: As of February 5, there were seven covid-related deaths in the placebo group in the trial and no covid-related deaths in the vaccine group.

BUT NO DATA ON THE ELDERLY: There were too few data generated by the J&J Phase 3 study to determine if the vaccine works in people over the age of 75. Moderna and Pfizer did not have an age cap in their EUAs.

ALSO, NOT FOR CHILDREN: The J&J vaccine hasn’t been tested yet in children under the age of 18, so it will not be authorized for use in them.

by RM NAIR

WASHINGTON, Feb 26: The US Food and Drug Administration (FDA) has said the Johnson & Johnson covid vaccine has met the requirements for emergency use authorization (EUA) as per the data provided to them. The FDA was only releasing an analysis of the clinical trial data that the company had submitted. It has to be recommended by the advisory committee and then only the FDA will issue the EUA. When okayed, it will become the third vaccine to be administered in the US.

The efficacy of the Johnson & Johnson vaccine against moderate to severe covid across all geographic areas was 66.9% at least 14 days after the single-dose vaccination and 66.1% at least 28 days after vaccination, according to the analysis which will be assessed by the advisory committee (VRBPAC) soon (which began the session on Friday morning), and based on its recommendation thereafter the FDA will issue the emergency use authorisation (EUA).

The final decision about the single dose vaccine is likely to be out on Saturday. Johnson & Johnson has several advantages over the other two vaccines currently being administered in the US - Pfizer and Moderna, both using the latest technology of mRNA, which is an instruction to the human cell to produce the vaccine on its own. And not in itself a vaccine as such. The new technology which has been in the making for two decades is set to revolutionise the concept of curative and preventive medicine.

"There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection," the Johnson & Johnson analysis said.

The Johnson & Johnson vaccine is claimed to work better than initial data showed against the virus variants. The variants, which are more contagious, are behind majority of cases in several countries like South Africa and the UK.

It was also claimed that the vaccine has a 72% efficacy rate in the US and a more than 68% rte in Brazil in protecting people from mild to severe illness. It offered nearly 86% protection against severe illness in the US and nearly 82% in South Africa and nearly 88% in Brazil.

The vaccine is also majorly claimed to inhibit asymptomatic infection, reducing the chances of transmission to a great extent, apart from preventing the disease in the inoculated. There were no reported cases of anaphylaxis following vaccination. As of February 5, there were seven covid-related deaths in the placebo group in the trial and no covid-related deaths in the vaccine group.

The US has ordered 100 million doses of the J&J vaccine, but supplies are not likely before April.

It is likely the Vaccines and Related Biological Products Advisory Committee (VRBPAC), currently in meeting, will recommend FDA authorisation (EUA) for the J&J vaccine, and the FDA will do so as early as Saturday, according to sources from the panel.

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