Argentine president tests positive for COVID-19

BUENOS AIRES - Argentina's President Alberto Fernandez, who has been vaccinated against COVID-19, announced late Friday that he had tested positive for the coronavirus.

"At the end of today, after presenting a fever of 37.3 (99 Fahrenheit) and a slight headache, I performed an antigen test, which was positive," he tweeted.

A PCR test later confirmed the diagnosis.

The president, who turned 62 on Friday, was in isolation as a precaution but said he was "physically well."

"Although I would have liked to end my birthday without this news, I am also in good spirits," he said. 

On Saturday, he told Radio 750 that he has "no idea how I got infected."

"I am someone who takes very good care of myself. If it were not for the vaccine, I would be having a very bad time," he said.

Fernandez was inoculated with the Russian Sputnik V vaccine and had his second shot on February 11, sources in the presidency told AFP.

Argentina is facing a second wave of the coronavirus with a sustained rise in cases. 

The South American country of 45 million inhabitants has recorded more than 2.3 million infections and over 56,000 deaths from COVID-19.

More than 4.1 million people there had been vaccinated as of Saturday.

Agence France-Presse

Venezuela's Maduro says son to join virus vaccine trial

CARACAS - Venezuelan President Nicolas Maduro said Sunday his son will join trials of Sputnik V, the coronavirus vaccine which was met with caution when Russia announced it was the world's first to be approved.

An initial batch of the vaccine arrived in Venezuela on Friday, the government announced, and 2,000 residents will participate in the trials.

"In this clinical trial phase, my son, Nicolas Ernesto Maduro Guerra, told me of his decision to be vaccinated with the Russian vaccine, to join the trial. I think it is very good," the socialist leader said in a speech on state television network VTV.

Maduro's sister is also a volunteer for the clinical trials.

Maduro Guerra, 30, is also a politician and a member of his father's governing United Socialist Party of Venezuela (PSUV).

Named "Sputnik V" after the historic Soviet-era satellite, the vaccine was met with skepticism from the global medical community.

Russia in August declared itself the first country to approve a coronavirus vaccine, although it is still undergoing large-scale clinical trials after promising results.

The drug is currently in Phase 3, the human testing state, and according to Moscow, more than 40,000 volunteers have been inoculated during the process.

"When the entire scientific, clinical and testing phase is closed, voluntary vaccination will come... As soon as we start mass vaccination, I am going to be the first one to get it," Maduro said.

Russia has been one of Maduro's main backers in the face of international pressure led by Washington, which seeks to displace him from power because it considers his reelection to have been fraudulent.

The US, as well as some 50 other countries, recognize Maduro's opponent, National Assembly speaker Juan Guaido, as Venezuela's interim president.

Guaido slammed the decision to participate in the Russian trials, saying, "They use our people as guinea pigs."

According to official figures, as of Saturday, Venezuela has registered 77,646 cases of Covid-19 out of the entire 30 million population, and 649 deaths. These numbers are disputed by the country's opposition and international organizations such as Human Rights Watch.

Agence France-Presse

Russia vaccine 'passes early trial test'

LONDON - Patients involved in early tests of a Russian coronavirus vaccine developed antibodies with "no serious adverse events", according to research published in The Lancet Friday, but experts said the trials were too small to prove safety and effectiveness.

Russia announced last month that its vaccine, named "Sputnik V" after the Soviet-era satellite that was the first launched into space in 1957, had already received approval. 

This raised concerns among Western scientists over a lack of safety data, with some warning that moving too quickly on a vaccine could be dangerous. 

Russia denounced criticism as an attempt to undermine Moscow's research.

In the Lancet study, Russian researchers reported on two small trials, each involving 38 healthy adults aged between 18 and 60, who were given a two-part immunization. 

Each participant was given a dose of the first part of the vaccine and then given a booster with the second part 21 days later. 

They were monitored over 42 days and all developed antibodies within the first three weeks. 

The report said the data showed that the vaccine was "safe, well tolerated, and does not cause serious adverse events in healthy adult volunteers". 

The trials were open-label and not randomized, meaning there was no placebo and the participants knew they were receiving the vaccine and were not randomly assigned to different treatment groups. 

Researchers underlined that larger and longer trials -- including a placebo comparison -- would be needed to establish the long-term safety and effectiveness of the vaccine for preventing Covid-19 infection.

The report said the 76 participants of these trials would be monitored up to 180 days, adding that a more rigorous phase 3 clinical trial was planned with the involvement of 40,000 volunteers "from different age and risk groups". 

'SAFETY IS PARAMOUNT'

Naor Bar-Zeev of Johns Hopkins Bloomberg School of Public Health, who was not involved in the study, said the research was "encouraging but small", adding that it did not give any data on effectiveness among older age groups, who are particularly vulnerable to COVID-19. 

"Showing safety will be crucial with COVID-19 vaccines, not only for vaccine acceptance but also for trust in vaccination broadly," he said in a commentary in the Lancet. 

"Since vaccines are given to healthy people and, during the COVID-19 pandemic, potentially to everyone after approval following phase 3 trials, safety is paramount."

The pandemic has seen an unprecedented mobilization of funding and research to rush through a vaccine that can protect billions of people worldwide.

This week the US urged states to get ready for a potential COVID-19 vaccine rollout two days before the presidential election in November, sparking concerns President Donald Trump's administration is accelerating research to fit a political timetable. 

Russia has said that industrial production of its version is expected from September.

President Vladimir Putin said in early August that the vaccine gave "sustainable immunity" and that one of his own daughters had been inoculated, even though Russia's health ministry said clinical trials were not yet complete.

The World Health Organization has urged Russia to follow established guidelines and go "through all the stages" necessary to develop a safe vaccine. 

Sputnik V was developed by the Gamaleya research institute for epidemiology and microbiology in Moscow in coordination with the Russian defense ministry. 

It uses a cold-causing adenovirus, which is then modified and combined with a part of the new coronavirus, SARS-CoV-2.

The report's lead author, Denis Logunov of Gamaleya, said the adenovirus vaccine enters people's cells and delivers the SARS-CoV-2 spike protein genetic code, helping the immune system "recognize and attack" the virus. 

Agence France-Presse

Russia to test coronavirus vaccine on 40,000 people

Russia said on Thursday it would start clinical trials of its controversial coronavirus vaccine next week, involving tens of thousands of people.

President Vladimir Putin said earlier this month that Russia had become the first country to register a coronavirus vaccine, though the announcement was met with caution from scientists and the World Health Organization who said it still needed a rigorous safety review.

Russia's sovereign wealth fund, which finances the vaccine project, said in a statement Thursday that tests of the "immunogenicity and safety of the Sputnik V vaccine" will begin next week involving more than 40,000 people.

It said the tests were the equivalent of the Phase 3 trials that other vaccines are undergoing.

Kirill Dmitriyev, the head of the Russian Direct Investment Fund, told an online briefing that the vaccination of at-risk groups, including medical personnel, would also start next week on a voluntary basis.

More than 20 countries have made requests to purchase over a billion doses of the vaccine, he said, adding that Russia had agreements with several countries to produce it.

He said mass vaccinations in Russia are expected to start in October and the first foreign deliveries in November or December.

The vaccine -- named after the pioneering 1950s Soviet satellite -- was announced with much fanfare in Russia but drew warnings from Western scientists that Moscow may be moving too quickly.

Dmitriyev said scepticism was starting to wane.

"We have seen a significant change in tone from the WHO. At first, yes, they did not have enough information on the Russian vaccine, now official information has been sent and they will evaluate it," he said. 

But he added: "We do not see any obstacle for individual regulators to approve the Russian vaccine without the approval of the WHO."

Russia had registered more than 942,000 confirmed coronavirus infections as of Thursday, the fourth-highest number after the United States, Brazil and India, and more than 16,000 deaths.

Agence France-Presse

Russia produces first batch of virus vaccine, says ministry

Russia said Saturday that it has produced the first batch of its coronavirus vaccine, after President Vladimir Putin announced it had been first in the world to approve a vaccine.

Putin's announcement on Tuesday about the vaccine was met with caution from scientists and the World Health Organization who said it still needed a rigorous safety review.

"The first batch of the novel coronavirus vaccine developed by the Gamaleya research institute has been produced," the health ministry said in a statement quoted by Russian news agencies.

Putin said the vaccine was safe and that one of his own daughters had been inoculated, though clinical trials were not yet complete and final stage testing involving more than 2,000 people only started this week.

Western scientists were skeptical, with some warning that moving too quickly on a vaccine could be dangerous, but Russia denounced criticism as an attempt to undermine Moscow's research.

The Russian vaccine is called "Sputnik V" after the Soviet-era satellite that was the first launched into space in 1957.

It was developed by the Gamaleya research institute for epidemiology and microbiology in Moscow in coordination with the Russian defense ministry.

The head of the institute, Alexander Gintsburg, told the TASS state news agency on Saturday that volunteers taking part in the final stage testing of the vaccine's safety and efficacy would have two inoculations.

Russia has said that industrial production is expected from September and that it plans to manufacture 5 million doses per month by December or January.

Health Minister Mikhail Murashko said this week that the vaccine would first be made available to medics and would later be available to all Russians on a voluntary basis.

With more than 917,000 confirmed infections, Russia's coronavirus caseload is currently fourth in the world after the United States, Brazil and India.

Currently Russia has 92,000 people hospitalized with the virus and 2,900 in intensive care, according to the health ministry.

Agence France-Presse