top of page

Brazil decided to stop Coronavac clinical trials was technical

The interruption was motivated by the absence of detailed information sent to Anvisa in relation to the study


Brazil decided to stop Coronavac clinical trials was technical
The interruption was decided by the General Management of Medicines, an technical area of ​​Anvisa. - Photo: Fabio Rodrigues Pozzebom / Agência Brasil

Nov 11, Rio De Janeiro: The interruption of the clinical study of the Chinese vaccine Coronavac determined by the National Health Surveillance Agency (Anvisa), this Monday (9), was a technical decision because of the lack of detailed information about the research about a serious adverse event not expected. The information was provided by the agency's CEO, Antônio Barra Torres.



“The reason is that the information released yesterday was considered by the technical area to be insufficient, incomplete, so that yesterday it would be possible, in their possession, to continue allowing vaccine development. In the face of incomplete information, the technical area only has a decision to make when it is experiencing an unexpected serious adverse event ”, explains Antônio Barra, at a press conference this Tuesday (10).



According to Barra, in the face of an unexpected serious adverse event in which, at first, it is not possible to establish a correlation, the indicated thing is to interrupt the study until everything is clarified so as not to work in a state of doubt.


“It is no joke to certify that a vaccine can be given to a person, this cannot occur in the presence of doubt. And a doubt, to be taken away, accurate and complete documents must be sent to us. And that didn't happen, ”he says.


Serious adverse events are considered: death; potentially fatal adverse event; persistent or significant disability/disability; requires hospitalization of the patient or prolongs hospitalization; congenital anomaly or birth defect; any suspicion of transmission of an infectious agent through a medical device; and clinically significant event.



Technical decision

Barra explained that the interruption was decided by the General Management of Medicines, a technical area of ​​Anvisa. The measure is provided for by the agency's rules and is part of the Good Clinical Practice procedures expected for clinical studies conducted in Brazil. As of the decision, no new volunteers can be vaccinated.


According to Anvisa, during the clinical study, it is not uncommon for interruptions to occur as a safety measure to maintain the integrity of the volunteers.


At the news conference, the agency said that the position to stop clinical trials could be changed when the circumstances of the unexpected serious adverse event are clarified by official sources.



“The decision made yesterday by the General Management of Medicines was the only one to be taken in doubt, so that, once the necessary information is obtained, it authorizes the proceeding or not. As simple as that, there is nothing more than that ”, points out the CEO of Anvisa.


Tests with Coronavac

In July, Anvisa authorized the Butantan Institute, in partnership with the Chinese pharmaceutical company Sinovac Biotech, to start phase three of the clinical trials to test the effectiveness and safety of the vaccine called CoronaVac. The volunteers are health professionals who work to care for patients with Covid-19.


Continue reading more from the below Tags

13 views0 comments

Comments


Planner 5D- Interior design app

Planner 5D- Interior design app

Flipkart Online Shopping App

Flipkart Online Shopping App

World population to reach 8 billion this year, as the growth rate slows

July 12, 2022 at 6:57:56 AM

15 November 2022 is predicted to be the day that the global population reaches eight billion. The projection is revealed in the UN’s World Population Prospects 2022 report, which also shows that India is on course to surpass China as the world’s most populous country in 2023.

World population to reach 8 billion this year, as the growth rate slows

WHO: Nearly one billion people have a mental disorder

June 22, 2022 at 7:20:50 AM

Nearly one billion people worldwide suffer from some form of mental disorder, according to the latest UN data – a staggering figure that is even more worrying if you consider that it includes around one in seven teenagers.

WHO: Nearly one billion people have a mental disorder

What can the UN do? Check the top 5 questions answered

April 6, 2022 at 10:51:48 AM

The current war in Ukraine, following the Russian invasion, has sparked all sorts of questions about the United Nations, particularly the role of the Security Council, the General Assembly and the Secretary-General.

What can the UN do? Check the top 5 questions answered

Ukraine: UN’s Guterres joins call for Bucha war crimes probe

April 6, 2022 at 8:22:29 AM

UN chief António Guterres on Tuesday added his voice to the growing international calls for a war crimes investigation into the killing of civilians in the Ukrainian town of Bucha.

Ukraine: UN’s Guterres joins call for Bucha war crimes probe

Recent terrorist attacks in Israel undermine ‘prospects for peace’: Guterres

March 31, 2022 at 8:29:57 AM

Secretary-General António Guterres on Tuesday night condemned recent terrorist attacks in Israel that have claimed the lives of at least 11 Israeli citizens.

Recent terrorist attacks in Israel undermine ‘prospects for peace’: Guterres

China's BYD ceases to produce gasoline-powered vehicles

4/4/22, 7:00 AM

Chinese auto manufacturer BYD announced Sunday that it has already ceased the production of traditional gasoline-powered vehicles starting from March.

China's BYD ceases to produce gasoline-powered vehicles

Performance-oriented all-new ŠKODA SLAVIA 1.5 TSI Launched creates a segment of its own

3/27/22, 10:42 AM

All new ŠKODA SLAVIA 1.5 TSI starts at ₹ 16.19 lacs

Performance-oriented all-new ŠKODA SLAVIA 1.5 TSI Launched creates a segment of its own

CARS24 Raises $450 Million, Nearly Doubles Its Valuation To $1.84 Billion

9/25/21, 6:16 AM

CARS24, India’s leading e-commerce platform for pre-owned vehicles, announced today the closing of a $450M round of funding including a $340M Series F equity round alongside $110M debt from diversified financial institutions.

CARS24 Raises $450 Million, Nearly Doubles Its Valuation To $1.84 Billion

Tata Motors launches the ‘XPRES’ brand for fleet customers

7/18/21, 6:13 PM

Tata Motors, one of India’s leading automobile manufacturers, today announced the launch of a new brand ‘XPRES,’ exclusively for fleet customers.

Tata Motors launches the ‘XPRES’ brand for fleet customers

Audi India announces curated ownership plans for Audi e-tron and Audi e-tron Sportback customers

7/18/21, 5:56 PM

Special Service Plans, Extended Warranty and Buyback for a hassle-free ownership experience

Audi India announces curated ownership plans for Audi e-tron and Audi e-tron Sportback customers

TikTok hits 1 billion global active users

9/28/21, 8:56 AM

TikTok mission is to inspire creativity and bring joy.

TikTok hits 1 billion global active users

FACT CHECK: Crypto is increasingly being used for criminal activity and is a haven for illicit finance

6/23/21, 6:11 AM

Because cryptocurrency is still new, we are often asked about the biggest myths surrounding it. It’s common for a new market or product to confuse people until they get familiar with it. Think about Airbnb: the idea of staying in a stranger’s home seemed crazy until it didn’t.

FACT CHECK: Crypto is increasingly being used for criminal activity and is a haven for illicit finance

PUBG: NEW STATE surpasses 17 Million Google play store PRE-REGISTRATIONS following its recent ALPHA TEST

6/19/21, 4:40 AM

KRAFTON, Inc. to open pre-registration for the game on Apple’s App Store in Q3 2021

PUBG: NEW STATE surpasses 17 Million Google play store PRE-REGISTRATIONS following its recent ALPHA TEST
bottom of page