BRASILIA: Brazil’s health regulator said Thursday its decision to reject the Russian-made Sputnik V coronavirus vaccine was based on the developer’s own data, after the latter threatened to sue for defamation.
Brazilian regulators’ decision Monday to deny emergency use authorization for the vaccine has blown up into an all-out international row, with Sputnik V’s makers accusing them of “knowingly spreading false and inaccurate information” without testing the vaccine themselves.
The Brazilian agency, Anvisa, based the decision on evidence the vaccine carried a live version of adenovirus, a common cold-causing virus.
It fired back defensively in a press conference that it had drawn that conclusion from information “submitted by the Sputnik V vaccine developer itself.”
“Anvisa was accused of lying, of acting unethically, of disseminating fake news about replicating adenovirus,” said the agency’s director, Antonio Barra Torres.
“We refute this grave accusation.”
The spat came three days after Anvisa announced it had denied a request from several states to import Sputnik V, saying its experts had flagged “uncertainties” about the jab.
The Brazilian government, which is struggling to secure enough vaccines for the hard-hit country’s 212 million people, had been negotiating the purchase of 30 million Sputnik doses.
The vaccine’s developers said Tuesday the decision was politically motivated, then upped their response Thursday.
“Sputnik V is undertaking a legal defamation proceeding in Brazil against Anvisa,” the developer said on the official Sputnik V Twitter account.
“Anvisa made incorrect and misleading statements without having tested the actual Sputnik V vaccine.”
The issue centers around an “adenovirus vector” — a virus that normally causes mild respiratory illness but in vaccines is genetically modified so that it cannot replicate, and edited to carry the DNA instructions for human cells to develop the spike protein of the virus that causes Covid-19.
This in turn trains the human system to be prepared in case it encounters the real coronavirus.
The Sputnik V vaccine uses two different adenovirus vectors to accomplish this task, administered in two shots.
According to a slideshow presented by Anvisa regulators, the agency determined that the booster shot was “replication competent” — meaning that once inside the body, the adenovirus can continue to multiply.
They added that this had likely occurred because of a manufacturing problem.
The Russian vaccine has been approved for use in at least 60 countries, including more than 10 in Latin America.
But it has not yet been approved by the European Medicines Agency (EMA) or the United States’ Food and Drug Administration (FDA).
Some Western countries have been wary of Sputnik V — named after the Soviet-era satellite — over concerns the Kremlin would use it as a soft-power tool to advance its interests.
Moscow registered the jab in August before large-scale clinical trials, but leading medical journal The Lancet has since said it is safe and more than 90 percent effective.
Russia-Brazil spat erupts over Sputnik vaccine snub
https://arab.news/64c3k
Russia-Brazil spat erupts over Sputnik vaccine snub
- Sputnik V’s makers accused Brazil's health regulator Anvisa of spreading false information about the vaccine
- Anvisa says it had denied requests to import Sputnik V, saying its experts had flagged “uncertainties” about the jab
In Ethiopia, Tigrayans fear return to ‘full-scale war’
- Flights have been suspended into Tigray since Thursday and local authorities reported drone strikes on goods lorries
- The international community fears the fighting could turn into an international conflict between Ethiopia and Eritrea
ADDIS ABABA: Tigrayans in northern Ethiopia fear a return to all-out war amid reports that clashes were continuing between local and federal forces on Monday, barely three years after the last devastating conflict in the region.
The civil war of 2020-2022 between the Ethiopian government and Tigray forces killed more than 600,000 people and a peace deal known as the Pretoria Agreement has never fully resolved the tensions.
Fighting broke out again last week in a disputed area of western Tigray called Tselemt and the Afar region to the east of Tigray.
Abel, 38, a teacher in Tigray’s second city Adigrat, said he still hadn’t recovered from the trauma of the last war and had now “entered into another round of high anxiety.”
“If war breaks out now... it could lead to an endless conflict that can even be dangerous to the larger east African region,” added Abel, whose name has been changed along with other interviewees to protect their identity.
Flights have been suspended into Tigray since Thursday and local authorities reported drone strikes on goods lorries on Saturday that killed at least one driver.
In Afar, a humanitarian worker, speaking to AFP on condition of anonymity, said there had been air strikes on Tigrayan forces and that clashes were ongoing on Monday, with tens of thousands of people displaced.
AFP could not independently verify the claims and the government has yet to give any comment on the clashes.
In the regional capital Mekele, Nahom, 35, said many people were booking bus tickets this weekend to leave, fearing that land transport would also be restricted soon.
“My greatest fear is the latest clashes turning into full-scale war and complete siege like what happened before,” he told AFP by phone, adding that he, too, would leave if he could afford it.
Gebremedhin, a 40-year-old civil servant in the city of Axum, said banks had stopped distributing cash and there were shortages in grocery stores.
“This isn’t only a problem of lack of supplies but also hoarding by traders who fear return of conflict and siege,” he said.
The region was placed under a strict lockdown during the last war, with flights suspended, and banking and communications cut off.
The international community fears the fighting could turn into an international conflict between Ethiopia and Eritrea, whose relations have been increasingly tense in recent months.
The Ethiopian government accuses the Tigrayan authorities and Eritrea of forging closer ties.
United Nations Secretary-General Antonio Guterres is “deeply concerned about... the risk of a return to a wider conflict in a region still working to rebuild and recover,” his spokesman said.
The EU said that an “immediate de-escalation is imperative to prevent a renewed conflict.”
