Brazilian firm to produce Russian vaccine without regulatory approval

BRASILIA (Reuters) – The Brazilian pharmaceutical company that plans to produce Russia’s Sputnik V coronavirus vaccine will start making it next week even before health regulator Anvisa gives approval for use in Brazil, the company’s chief executive said on Friday.

União Quimica’s facility in São Paulo has been certified by Anvisa for good production practices and the vaccine will be made for export to countries that have approved it, said CEO and founder Fernando Marques.

“We intend to start production next week with a view to export,” Marques said. He said Sputnik V will not be used in Brazil until it is approved, but neighboring Latin American countries have approved the vaccine and want deliveries.

Anvisa last week held off approving imports of Sputnik V sought by Brazilian state governors amid a second wave of the virus that has killed more than 415,000 Brazilians.

In a setback for the Russian vaccine, the regulator’s technical staff warned of “flaws” in the development and clinical testing of Sputnik, said the data presented on the vaccine’s safety and efficacy was incomplete.

Marques on Friday told a Senate commission on COVID-19 that União Quimica expects to receive a batch of active ingredient from Moscow next week to start making the vaccine for export at its plant near São Paulo’s Guarulhos airport.

“So, the situation today is this: we will start production, obviously when we receive the active ingredient, and we will wait for the registration to make the local production available for use in Brazil,” he told senators.

The Russian Direct Investment Fund that is marketing Sputnik V developed by Russia’s Gamaleya Research Institute has plans to supply the vaccine to Latin American countries from Brazil.

(Reporting by Anthony Boadle; editing by Grant McCool)

PAHO warns younger people filling up intensive care COVID-19 wards

BRASILIA (Reuters) – COVID-19 infections continue to spread fast across the Americas as a result of relaxed prevention measures and intensive care units are filling up with younger people, the director of the Pan American Health Organization (PAHO) Carissa Etienne said on Wednesday.

In Brazil, mortality rates have doubled among those younger than 39, quadrupled among those in their 40s and tripled for those in their 50s since December, she said.

Hospitalization rates among those under 39 years have increased by more than 70% in Chile and in some areas of the United States more people in their 20’s are now being hospitalized for COVID-19 than people in their 70’s.

(Reporting by Anthony Boadle)

Poland tightens quarantine rules after cases of Indian COVID-19 variant

WARSAW (Reuters) – People travelling to Poland from Brazil, India and South Africa will have to quarantine, the Polish health minister said on Tuesday, as he announced cases of a COVID-19 variant first detected in India in the Warsaw and Katowice areas.

The outbreaks poses a fresh risk to Poland just as it starts to emerge from a highly damaging third wave of the pandemic.

“In the case of Brazil, India and South Africa, people travelling from these locations will automatically have to quarantine without the possibility of getting an exception due to a test,” Health Minister Adam Niedzielski told a news conference.

The number of infections involving the Indian variant in Poland has now reached 16, including two cases in the family of a Polish diplomat who had returned from India, Niedzielski said.

Poland has so far reported 2,808,052 cases of COVID-19 and 68,133 deaths.

Poland reopened shopping centers on Tuesday, the beginning of a gradual unfreezing of the economy that will see restaurants, hotels and schools reopening at different points in May.

(Reporting by Alan Charlish and Pawel Florkiewicz; Editing by Gareth Jones)

U.S. to ease COVID-19 travel restrictions for Chinese students

By David Shepardson

WASHINGTON (Reuters) – The Biden administration will ease travel restrictions allowing Chinese students to come to the United States for classes this fall and from other countries where most non-U.S. citizens are barred because of the coronavirus pandemic, government officials told Reuters.

The U.S. State Department is set to announce later on Tuesday it is expanding its national interest exemptions to cover students and academics around the world starting on Aug. 1 after it made the change in March for European students, officials said.

The United States has barred most non-U.S. citizens from the United States who have been in China, Brazil, South Africa, Iran and most of Europe within the prior two weeks. Now students from all those countries will be eligible to enter the United States in a few months’ time.

The largest number of international students in the United States are from China. About 35% of international students in the United States in the 2019-20 school year were from China, according to the International Education Exchange (IEE), nearly twice as high as the second highest, India.

In the 2019-20 academic year 372,000 Chinese nationals attended universities and colleges in the United States, the IEE said in a November 2020 report.

In January 2020 then President Donald Trump first imposed the restrictions barring nearly all non-U.S. citizens who were in China from entering the United States.

U.S. colleges and universities have been urging the State Department to take the step before international students had to make enrollment decisions.

The American Council on Education had pressed the administration of President Joe Biden to act quickly, saying in a letter last month the administration could “deliver a welcoming message to current and prospective international students, which can help restore the U.S. as a destination of choice, as well as supporting an important economic activity as the U.S. economy recovers from the COVID-19 pandemic.”

Another big issue has been the requirement that first-time student visa applicants have in-person interviews at U.S. embassies and consulates.

The group cited a study that the overall economic impact generated by international students had declined by $1.8 billion during the 2019-2020 academic year, from $40.5 billion in the prior year.

(Reporting by David Shepardson; Editing by Chizu Nomiyama and Grant McCool)

Nowhere as worrisome for COVID-19 as South America, Brazil especially concerning – Pan American Health official

By Julia Symmes Cobb

BOGOTA (Reuters) – South America is now the most worrying region for COVID-19 infections, as cases mount in nearly every country, the director of the Pan American Health Organization (PAHO) said on Wednesday.

“Nowhere are infections as worrisome as in South America,” Director Carissa Etienne said during a weekly news conference.

Brazil has seen the most merciless surge. Scientists forecast it will soon surpass the worst of a record January wave in the United States, with daily fatalities climbing above 4,000 on Tuesday.

“The situation in Brazil is concerning countrywide,” said COVID-19 incident director Sylvain Aldighieri. “Our concern at the moment is also for the Brazilian citizens themselves in this context of health services that are overwhelmed.”

Brazil needs access to more COVID-19 vaccines now and should be able to receive them through global partnerships, Aldighieri said.

PAHO can expand its help to Brazilian states if requested, he said, adding it is already aiding with virus genetic sequencing, procuring oxygen and coronavirus testing.

Intensive care units are nearing capacity in Peru and Ecuador, and in parts of Bolivia and Colombia cases have doubled in the last week, Etienne said, adding that the southern cone is also experiencing an acceleration in cases.

The United States, Brazil and Argentina are among the 10 countries seeing the highest number of new infections globally, she added.

The Americas recorded more than 1.3 million new coronavirus cases and over 37,000 deaths last week, Etienne said, more than half of all deaths reported globally.

“We cannot ease public health and social interventions without good data and justification,” Etienne said, adding slowing and stopping transmission “requires decisive action by local and national governments.”

More than 210 million vaccine doses have been administered across the Americas, Etienne said.

Bolivia, Nicaragua and Haiti may be affected by Serum Institute of India vaccine shipment delays, said sub-director Jarbas Barbosa, but the World Health Organization is appealing to the Indian government to ensure shipment agreements.

(Reporting by Julia Symmes Cobb; Editing by Bill Berkro)

Brazil scrambles to secure sedatives as hospitals overwhelmed by COVID-19

By Reuters Staff

SAO PAULO (Reuters) – An emergency shipment of sedatives needed to intubate severely ill COVID-19 patients arrived in Brazil late on Thursday from China, as the South American country scrambles for supplies due to severe shortages of the vital drugs.

In recent days, Rio de Janeiro and Sao Paulo have both sounded the alarm over shortages of sedatives, with Sao Paulo’s Health Secretary saying the city’s ability to care for seriously ill COVID-19 patients is on the verge of collapse.

Brazil has become the epicenter of the pandemic, with more Brazilians dying of the virus each day than anywhere else in the world.

President Jair Bolsonaro has opposed lockdowns and held large events in which he often does not wear a mask. He has only recently embraced vaccines as a possible solution.

The cargo of 2.3 million drugs, donated by major Brazilian companies including miner Vale and oil producer Petrobras, touched down in Sao Paulo just after 10 p.m. local time.

As the health crisis worsens, Brazil is also negotiating with other countries for emergency supplies, with donations from Spain expected to arrive next week.

Brazil has recorded a total of 365,444 coronavirus deaths – second only to the United States – and 13,746,681 confirmed COVID-19 cases.

Brazil’s COVID-19 response cost thousands of lives, says humanitarian group

By Reuters Staff

RIO DE JANEIRO (Reuters) – The Brazilian government’s “failed response” to the pandemic led to thousands of otherwise avoidable deaths and created a humanitarian catastrophe that is still playing out, aid group Medecins Sans Frontieres (MSF) said on Thursday.

Brazil’s COVID-19 outbreak is the deadliest in the world after the United States and is currently leading in average daily mortalities. Last week more than a quarter of all global deaths were in Brazil.

A brutal second wave has hospitals saying they are running short of crucial drugs for intubating patients and most Brazilian states report that intensive care units are at or near capacity.

Right-wing President Jair Bolsonaro has opposed lockdowns, and has held large events in which he often does not wear a mask. He has only recently embraced vaccines as a possible solution.

“More than one year into the COVID-19 pandemic, the failed response in Brazil has caused a humanitarian catastrophe,” said Christos Christou, a medical doctor and president of MSF, sometimes called Doctors Without Borders in English.

“Each week there is a grim new record of deaths and infections – the hospitals are overflowing and yet there is still no coordinated centralized response,” Christou said in a briefing with reporters, adding the situation was expected to become even worse in the weeks ahead.

Bolsonaro has openly fought against state and local governments seeking to institute lockdowns, saying Brazilians need to get on with normal life and that job losses are more dangerous than the virus.

MSF Director-General Meinie Nicolai said the surge in cases cannot be blamed only on the contagious Brazilian COVID-19 variant, known as P.1.

“The P.1 variant is certainly a problem, but this doesn’t explain the situation in Brazil,” she said.

India approves Russia’s Sputnik V COVID-19 vaccine

By Nigam Prusty and Krishna N. Das

NEW DELHI/MOSCOW (Reuters) -India has approved the use of Russian Sputnik V COVID-19 vaccine, the Russian Direct Investment Fund (RDIF) said on Monday, confirming earlier reports of its imminent endorsement.

India overtook Brazil to become the nation with the second highest number of infections worldwide after the United States, as it battles a second wave, having given about 105 million doses among a population of 1.4 billion.

The RDIF, which is responsible for marketing the vaccine abroad, said the Drug Controller General of India (DCGI) had approved the use of Sputnik V.

“India, the world’s 2nd most populous nation, became the 60th country to register #SputnikV after positive results of local Phase 3 clinical study. Sputnik V is now authorized in 60 countries with population of over 3 bln people,” a post on the Sputnik V official Twitter account said.

Earlier on Monday, two people familiar with the matter said the panel of the Central Drugs Standard Control Organization (CDSCO) had recommended the authorization.

The RDIF has signed deals to produce more than 750 million doses of Sputnik V in India with six domestic firms.

India has so far used two vaccines, one developed by AstraZeneca and Oxford University, and the other by domestic firm Bharat Biotech.

Sputnik V, developed by Moscow’s Gamaleya Institute, has proved 91.6% effective against COVID-19 and has been approved for use in more than 50 countries.

The Indian drugs regulator did not respond to a request for comment on the expert panel’s approval of the Russian vaccine.

Indian pharmaceutical firm Dr. Reddy’s, which is marketing the vaccine in India, said it was awaiting formal word from the authorities.

“Dr. Reddy’s and RDIF are working diligently with the Indian regulatory authorities to obtain the approval for Sputnik V. We are fully committed to playing our part in India’s fight against COVID,” the company said.

Shares of Dr. Reddy’s ended up 5% after the Economic Times newspaper first reported the news.

The firm has helped run a small domestic trial to test the vaccine’s safety and ability to generate an immune response.

(Additional reporting by Rama Venkat and Shivani Singh in Bengaluru, Polina Ivanova and Vladimir Soldatkin in Moscow; Writing by Sachin Ravikumar; Editing by William Maclean and Angus MacSwan)

WHO warns on Brazil COVID-19 outbreak as Bolsonaro blasts Senate inquiry

By Eduardo Simões

SAO PAULO (Reuters) – Brazilian President Jair Bolsonaro on Friday blasted a pending Senate inquiry on his handling of a record-breaking COVID-19 outbreak, which global health officials compared to a “raging inferno.”

Supreme Court Justice Luis Roberto Barroso ruled late on Thursday that enough senators had signed on to a proposed inquiry on the government’s pandemic response to launch the probe despite stalling by Senate leadership.

“It’s a stitch-up between Barroso and the leftists in the Senate to wear out the government,” Bolsonaro told supporters outside his residence, accusing the judge of “politicking.”

A Senate investigation represents the most severe political consequence to date for Bolsonaro’s approach to the coronavirus, which he compared to a “little flu” last year as he ignored health experts calling for mask wearing and social distance.

Bolsonaro has backed off his criticism of COVID-19 vaccines, but he continues to attack governors attempting lockdowns and even milder measures, accusing them without proof of killing more with those restrictions than the virus itself.

COVID-19 has taken more than 345,000 lives in Brazil, second only to the United States. One in four deaths from the pandemic this week were in Brazil, where a brutal wave is overwhelming hospitals and setting records of more than 4,000 deaths per day.

“What you are dealing with here is a raging inferno of an outbreak,” said Bruce Aylward, senior adviser to the director general of the World Health Organization, in a public briefing.

Yet fatigue and political pressure from Bolsonaro have pushed some governors to ease restrictions despite record deaths.

The state of Sao Paulo, whose governor has been a critic of the president, announced that it was loosening some restrictions next week even as its hospitals struggle to manage case loads.

Sao Paulo officials said a downtick in hospitalizations had justified the decision to restart soccer matches without spectators, reopen stores selling building materials and resume take-out service at restaurants.

(Reporting by Eduardo Simoes; Additional reporting by Tatiana Bautzer; Editing by Brad Haynes and Dan Grebler)

Nowhere as worrisome for COVID-19 infections as South America, Brazil concerning: PAHO

By Julia Symmes Cobb

BOGOTA (Reuters) – South America is the most worrying region for COVID-19 infections, as cases mount in nearly every country, the director of the Pan American Health Organization (PAHO) said on Wednesday.

“Nowhere are infections as worrisome as in South America,” Director Carissa Etienne said during a weekly press conference.

Brazil has seen perhaps the most merciless surge and scientists forecast it will soon surpass the worst of a record January wave in the United States, with daily fatalities climbing above 4,000 on Tuesday.

“The situation in Brazil is concerning countrywide,” said COVID-19 incident director Sylvain Aldighieri. “Our concern at the moment is also for the Brazilian citizens themselves in this context of health services that are overwhelmed.”

Brazil needs access to more vaccines now and should be able to receive them through global partnerships, Aldighieri said.

PAHO can expand its help to Brazilian states if requested, he said, adding it is already aiding with virus sequencing, procuring oxygen and testing.

Intensive care units are nearing capacity in Peru and Ecuador and in parts of Bolivia and Colombia cases have doubled in the last week, Etienne said, adding the southern cone is also experiencing acceleration in cases.

The U.S., Brazil and Argentina are among the ten countries seeing the highest number of new infections globally, she added.

The Americas recorded more than 1.3 million new coronavirus cases and over 37,000 deaths last week, Etienne said, more than half of all deaths reported globally.

“We cannot ease public health and social interventions without good data and justification,” Etienne said, adding slowing and stopping transmission “requires decisive action by local and national governments.”

More than 210 million vaccine doses have been administered across the Americas, Etienne added.

Bolivia, Nicaragua and Haiti may be affected by Serum Institute of India vaccine shipment delays, said sub-director Jarbas Barbosa, but the World Health Organization is appealing to the Indian government to ensure shipment agreements.

(Reporting by Julia Symmes Cobb)