Tag Archives: Biopharmaceutical (TRBC level 5)

Brazil has enough infection data to analyze the COVID-19 Sinovac vaccine – officials | Instant News


FILE PHOTO: A man works at the packaging facility of Chinese vaccine maker Sinovac Biotech, developing an experimental coronavirus disease (COVID-19) vaccine, during a government-organized media tour in Beijing, China, September 24, 2020. REUTERS / Thomas Peter / File Photo

SAO PAULO (Reuters) – Brazil has gathered enough infection data from the final-stage trial of the experimental COVID-19 vaccine developed by China’s Sinovac Biotech and expects interim results on its efficiency in early December, trial organizers said on Monday.

Dimas Covas, director of the Butantan biomedical research institute which is running the final-stage trial of the Sinovac vaccine in Brazil, said it now has 74 confirmed cases among the trial participants, above the 61 initial milestones set for an interim efficiency analysis.

He said the independent committee is likely to release efficiency results in the first week of December based on its data analysis.

The news comes as Britain’s AstraZeneca Plc on Monday joined US rivals Pfizer and Moderna and Russia in announcing positive results in a landmark trial, raising hopes that the world will soon have a successful vaccine to end the pandemic.

Covas said Brazil’s health ministry now had all the information needed to include Coronavac in the national program, while São Paulo’s Health Secretary Jean Gorinchteyn expected on Monday Brazilian regulators to approve the use of Sinovac’s vaccine, CoronaVac, in January.

João Gabbardo, head of Sao Paulo’s COVID-19 contingency committee, said at the same event that he expected China’s health regulators to approve Sinovac’s CoronaVac in December, which could speed up approval in Brazil.

The Sinovac vaccine has been promoted by Sao Paulo’s governor João Doria, a move that has put him at odds with President Jair Bolsonaro who is deeply skeptical of China.

Bolsonaro has attacked the Chinese vaccine for lacking credibility and it remains unclear whether the federal government will include it in its national inoculation program.

The ministry said on Sunday that it plans to sign a non-binding letter of intent to purchase vaccines from Pfizer Inc, Bharat Biotech India, Russia’s Direct Investment Fund, Moderna Inc and Janssen, a Johnson & Johnson unit, but did not mention Sinovac’s. candidate.

Reporting by Eduardo Simoes and Anthony Boadle, written by Stephen Eisenhammer; Edited by Bernadette Baum, Miyoung Kim & Shri Navaratnam

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Brazil has enough infection data to analyze the COVID-19 Sinovac vaccine – officials | Instant News


FILE PHOTO: A man works at the packaging facility of Chinese vaccine maker Sinovac Biotech, developing an experimental coronavirus disease (COVID-19) vaccine, during a government-organized media tour in Beijing, China, September 24, 2020. REUTERS / Thomas Peter / File Photo

SAO PAULO (Reuters) – Brazil has gathered enough infection data from the final-stage trial of the experimental COVID-19 vaccine developed by China’s Sinovac Biotech and expects interim results on its efficiency in early December, trial organizers said on Monday.

Dimas Covas, director of the Butantan biomedical research institute which is running the final-stage trial of the Sinovac vaccine in Brazil, said it now has 74 confirmed cases among the trial participants, above the 61 initial milestones set for an interim efficiency analysis.

He said the independent committee is likely to release efficiency results in the first week of December based on its data analysis.

The news comes as Britain’s AstraZeneca Plc on Monday joined US rivals Pfizer and Moderna and Russia in announcing positive results in a landmark trial, raising hopes that the world will soon have a successful vaccine to end the pandemic.

Covas said Brazil’s health ministry now had all the information needed to include Coronavac in the national program, while São Paulo’s Health Secretary Jean Gorinchteyn expected on Monday Brazilian regulators to approve the use of Sinovac’s vaccine, CoronaVac, in January.

João Gabbardo, head of Sao Paulo’s COVID-19 contingency committee, said at the same event that he expected China’s health regulators to approve Sinovac’s CoronaVac in December, which could speed up approval in Brazil.

The Sinovac vaccine has been promoted by Sao Paulo’s governor João Doria, a move that has put him at odds with President Jair Bolsonaro who is deeply skeptical of China.

Bolsonaro has attacked the Chinese vaccine for lacking credibility and it remains unclear whether the federal government will include it in its national inoculation program.

The ministry said on Sunday that it plans to sign a non-binding letter of intent to purchase vaccines from Pfizer Inc, Bharat Biotech India, Russia’s Direct Investment Fund, Moderna Inc and Janssen, a Johnson & Johnson unit, but did not mention Sinovac’s. candidate.

Reporting by Eduardo Simoes and Anthony Boadle, written by Stephen Eisenhammer; Edited by Bernadette Baum, Miyoung Kim & Shri Navaratnam

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Brazil will not relieve the makers of the COVID-19 vaccine from responsibility, said the deputy minister | Instant News


FILE PHOTOS: A vial labeled “Vaccine COVID-19” and a medical syringe seen in an illustration taken April 10, 2020. REUTERS / Dado Ruvic

BRASILIA (Reuters) – Brazil has no intention of enacting a law that would exempt COVID-19 vaccine makers from liability, the country’s deputy health minister Elcio Franco said Thursday.

Franco said a meeting held this week in Brasilia with vaccine developers should lead to a non-binding memorandum of understanding on possible future purchases of a vaccine against COVID-19.

He said the price and target population would be factors in deciding a purchase.

Reporting by Anthony Boadle; Edited by Chris Reese

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Brazil will receive China’s Sinovac COVID-19 vaccine, eyeing candidate Pfizer | Instant News


BRASILIA (Reuters) – The Brazilian state of Sao Paulo will begin importing the first of 46 million doses of China’s Sinovac vaccine to fight COVID-19 this week, while the federal government is taking a more cautious approach with a vaccine developed by Pfizer Inc.

Federal health officials met with Pfizer representatives on Tuesday as Brazil tried to secure vaccine supplies. The Health Ministry said in a statement that it would buy the Pfizer vaccine, which is currently in Phase 3 trials, if it is proven safe and registered with the Anvisa health authority.

While drawing up the immunization plan, the ministry will also meet this week with Johnson & Johnson, India’s Bharat Biotech and Russia’s Sputnik V. vaccine maker.

Brazil has the third-highest number of coronavirus cases in the world, leading pharmaceutical companies to carry out their vaccine trials in South America’s largest country.

State health authorities have taken a more aggressive stance than their federal counterparts in securing vaccine supplies.

The director of the Sao Paulo state Butantan Institute’s biomedical center, Dimas Covas, said at a congressional hearing on Tuesday that Butantan is expected to have 46 million doses of Sinovac ready in January for use if approved by Brazilian health regulator Anvisa.

Butantan is conducting phase 3 trials of the vaccine in Brazil, with Covas saying preliminary results show the vaccine has an excellent safety profile.

Covas said 10,000 volunteers have received about 19,000 shots of the two-dose vaccine, and 2,000 people still need to be included in the trial.

Anvisa suspended trials for a day and a half last week after the death of a volunteer, which police reported as suicide and Butantan said had nothing to do with the vaccine.

The temporary suspension did not affect clinical trials, Covas said, adding that Butantan had a “very good understanding” of Anvisa.

Butantan and Anvisa have sent experts to China where they are in a two-week quarantine before they can visit vaccine facilities, they said.

Reporting by Anthony Boadle, Ricardo Brito and Maria Carolina Marcello; Written by Jake Spring; Edited by Sonya Hepinstall and Peter Cooney

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Brazil will receive China’s Sinovac COVID-19 vaccine, eyeing candidate Pfizer | Instant News


BRASILIA (Reuters) – The Brazilian state of Sao Paulo will begin importing the first of 46 million doses of China’s Sinovac vaccine to fight COVID-19 this week, while the federal government is taking a more cautious approach with a vaccine developed by Pfizer Inc.

Federal health officials met with Pfizer representatives on Tuesday as Brazil tried to secure vaccine supplies. The Health Ministry said in a statement that it would buy the Pfizer vaccine, which is currently in Phase 3 trials, if it is proven safe and registered with the Anvisa health authority.

While drawing up the immunization plan, the ministry will also meet this week with Johnson & Johnson, India’s Bharat Biotech and Russia’s Sputnik V. vaccine maker.

Brazil has the third-highest number of coronavirus cases in the world, leading pharmaceutical companies to carry out their vaccine trials in South America’s largest country.

State health authorities have taken a more aggressive stance than their federal counterparts in securing vaccine supplies.

The director of the Sao Paulo state Butantan Institute’s biomedical center, Dimas Covas, said at a congressional hearing on Tuesday that Butantan is expected to have 46 million doses of Sinovac ready in January for use if approved by Brazilian health regulator Anvisa.

Butantan is conducting phase 3 trials of the vaccine in Brazil, with Covas saying preliminary results show the vaccine has an excellent safety profile.

Covas said 10,000 volunteers have received about 19,000 shots of the two-dose vaccine, and 2,000 people still need to be included in the trial.

Anvisa suspended trials for a day and a half last week after the death of a volunteer, which police reported as suicide and Butantan said had nothing to do with the vaccine.

The temporary suspension did not affect clinical trials, Covas said, adding that Butantan had a “very good understanding” of Anvisa.

Butantan and Anvisa have sent experts to China where they are in a two-week quarantine before they can visit vaccine facilities, they said.

Reporting by Anthony Boadle, Ricardo Brito and Maria Carolina Marcello; Written by Jake Spring; Edited by Sonya Hepinstall and Peter Cooney

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