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Montevideo, September 25th 2021 - 21:14 UTC

 

 

Anvisa grants shelf-life extension for 3 million doses of Janssen single-dose vaccine in Brazil

Tuesday, June 15th 2021 - 09:29 UTC
Full article
Anvisa made this decision because the FDA did it first. Anvisa made this decision because the FDA did it first.

Brazil's National Health Surveillance Agency (Anvisa) on Monday granted a shelf-life extension to 3 million doses of Janssen's Covid-19 vaccine.

The drug is now considered suitable for use for four and a half months, under storage conditions of 2°C to 8°C, instead of the original three months.

”The approval was based on careful evaluation of quality data from studies showing that the vaccine tends to remain stable for a period (4.5 months) and was considered a decision of the US Food and Drug Administration (FDA), which also approved such a change on June 10, 2021,“ Anvisa explained.

On Monday, health minister Marcelo Queiroga said that a batch of 3 million of the 38 million bought from Janssen by the federal government should arrive in Brazil on Wednesday 16 June. The minister stated Brasilia after a meeting at the Planalto Palace with President Jair Bolsonaro. ”I don't know the details yet. But a fourth batch should arrive,“ Queiroga said.

In a statement, the health ministry said the delivery will not take place on 15 June as previously announced. The lab says it is still negotiating with the federal government. ”We are still in dialogue with the Ministry of Health and other local authorities to make the vaccine available in the country as soon as possible. We will share new information as soon as there are updates,” according to the pharmaceutical company.

Delivery was dependent on FDA clearance, which was granted on 12 June. On Thursday 10 June, Johnson & Johnson, which is responsible for Janssen Pharmaceuticals, announced that the FDA had increased the expiry date of the Covid-19 vaccine from three to four and a half months.

According to the Ministry of Health, the vaccines will be distributed to capitals for logistical reasons and were initially due to expire on 27 June, but Anvisa extended the deadline, following the FDA's decision. The new expiry date should be extended to 8 August, as predicted by the ministry.

As the immunising agent is administered in a single dose, one application of the Janssen vaccine is equivalent to two doses of the other vaccines being used in Brazil (Pfizer, CoronaVac and AstraZeneca).

Meanwhile, Brazil recorded 37,948 new cases of the disease and 1,129 deaths in the last 24 hours on Sunday. The total number of infections in the country reached 17,412,766, with 487,401 deaths. Weekend numbers are generally lower due to reduced staffing levels in laboratories.

Several health authorities and institutions warn, however, that the real figures should be even higher, due to the lack of large-scale testing and underreporting.

Brazil has the second-highest number of deaths in the world, behind only the United States, with more than 599,000 deaths, and the third-highest number of confirmed cases, after the United States (33.4 million) and India (29.4 million).

More than 175 million people have officially contracted the coronavirus worldwide and 3.79 million deaths associated with the disease have been reported.

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