Russia's Sputnik V vaccine is still waiting for the European Medicines Agency (EMA) to start the countdown to its launch across the 27-nation bloc.

Why has the EU not approved Russia’s Sputnik jab?

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by Danny KEMP

Russia’s Sputnik V vaccine is still waiting for the European Medicines Agency (EMA) to start the countdown to its launch across the 27-nation bloc.

With Moscow and Brussels trading barbs over the length of time the Amsterdam-based regulator is taking, here is what we know so far:

– What’s the process? –
The EMA says Sputnik faces the same process as all other coronavirus vaccines.

This first stage is a “rolling review” of data and trials, which the EMA says Sputnik has not started.

That would be followed by a formal application for a one-year conditional marketing authorisation.

“They have to submit the whole set of data, indeed go through the whole scrutiny process, like any other vaccine,” European Commission chief Ursula von der Leyen said on February 17 about Sputnik.

Three vaccines are authorised for the EU: Pfizer-BioNTech, Moderna and AstraZeneca. One other, Johnson & Johnson, has applied for authorisation. Two others, Novavax and CureVac, have started rolling reviews.

– What does the EMA say? –
The EMA insisted in a “clarification” on February 10 that it had “to date not received an application for a rolling review or a marketing authorisation for… the Sputnik V vaccine, despite reports stating the opposite.”

The regulator confirmed to AFP that was still the case on February 18.

It also said that EMA’s experts themselves “need to give their agreement first before developers can submit their application for initiation of the rolling review process.”

The EMA has however said that Sputnik V’s backers submitted a request for “scientific advice” to prepare for a possible application for market authorisation, and confirmed a meeting took place on January 19 to discuss “further engagement”.

– What do the Russians say? –
Russian authorities tout the vaccine’s take-up by around 30 countries and a Lancet study showing it was 91.6 percent effective against symptomatic Covid-19 cases.

The developers and backers of Sputnik insist that a rolling review application has been made.

The Russian sovereign wealth fund, which backed the vaccine, said Russian authorities “filed a registration request” on January 19 — further than the step the EMA said was taken on that date.

The fund also rejected “misdirected” reports that, after Sputnik’s Twitter account posted a supposed filing of the registration, it turned out it had been sent to the wrong agency.

The fund insisted it was “working with the EMA to start a rolling review” and said the agency had a few days ago “appointed rapporteurs for the Sputnik V dossier”.

– Is Sputnik being treated the same as other vaccines? –
As it would be the first non-Western developed vaccine deployed in the EU, officials have said that Sputnik production sites outside the bloc would need to be inspected.

“They are not producing in Europe, so of course there should be an inspection process on the production sites,” von der Leyen said on February 17.

Brussels has been wary of Russian and Chinese vaccines, concerned that Moscow and Beijing would use them as soft power tools.

Von der Leyen herself raised questions about why Moscow was so keen to push the vaccine on the EU.

“Overall I must say, we still wonder why Russia is offering theoretically millions and millions of doses while not sufficiently progressing in vaccinating their own people,” she said.

Agence France-Presse

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POLITIKO / Across the Nation

POLITIKO / Latest News

Rule of law prevailed: Trillanes hails CA ruling junking revival of rebellion raps

Former senator Antonio Trillanes IV on Tuesday (March 2) hailed the favorable ruling of the Court of Appeals (CA) concerning his rebellion case.

“Today, the rule of law prevailed,” Trillanes declared.

With this, the former lawmaker also expressed gratitude to the appellate court for the favorable ruling.

“Nagpapasalamat ako sa mga CA justices na gumawa ng desisyong ito,” he stated.

“Sana all na judges and justices ay may ganitong sense of justice to check the prevailing authoritarianism in the country,” he added,

Trillanes’s petition before the CA assailed the 2018 orders of Makati City Judge Elmo Alameda to issue a hold departure order (HDO) and arrest warrant against the former lawmaker even though the same magistrate dismissed back in 2011 the rebellion case against him.

The case was dismissed by the judge in 2011 after Trillanes was granted amnesty by then President Benigno Aquino III.

The Department of Justice (DOJ) sought to revive the case before the Makati court after President Rodrigo Duterte revoked the amnesty.

Sinong guilty? Lord Velasco’s allies gang up on Alan Cayetano after ally exposes P20-B budget cut

By Billy Begas

Allies of House Speaker Lord Allan Jay Velasco slammed the camp of Taguig-Pateros Rep. Alan Peter Cayetano for his supporters’ attempt to drag the Marinduque lawmaker in the issue involving the P20 billion pension and gratuity fund of uniformed government personnel that was diverted to infrastructure projects.

Senior Deputy Speaker Salvador Leachon said it was clear based on the explanation of House Committee on Appropriations chairperson Eric Yap that the slashed P20 billion will not be used this year to pay the pension and gratuity of uniformed personnel.

“Based on Congressman Yap’s accounts, which I find to be accurate, the current problems involving the pension of uniformed retirees was due to the P70-billion cut in their budget for the year 2020, during Cayetano’s term,” Leachon said.

Yap said that the House then led by Cayetano slashed P70 billion from the 2020 national budget.

Earlier, Anakalusugan Rep. Michael Defensor said that he did not know what happened then. “Hindi ko ho alam kung nag-usap sila (House-led Cayetano and Department of Budget and Management) pero ang sigurado ko ho nagrereklamo ngayon ang DBM dahil binawasan ang pension fund.”

Yap claimed that the DBM knows the reduction of budget.

“Their unfounded allegations against Speaker Velasco boomeranged to them when it turned out the current problems faced by uniformed retirees was brought about by the more than P70 billion deducted from the 2020 PGF budget during Cayetano’s time,” said Leachon.

Defensor contradicted Leachon’s claim in a text message. “How can it have boomeranged when Chair Eric Yap admitted that they slashed the Pension and Gratuity Fund by 20 billion. They should not over complicate and over think- return the 20 billion to our military, police and uniformed personnel pension and gratuity fund.”

Defensor also challenged the camp of Velasco to show to the public that they did not use it as pork barrel fiund.

Deputy Speaker and Negros Oriental Rep. Arnolfo Teves said Defensor’s accusations were “part of an obvious attempt to antagonize Speaker Velasco.”

“It was obviously premeditated with some members of the so-called ‘BTS sa Kongreso’ present to interpellate Defensor and tried but failed to amplify the allegations against Speaker Velasco,” Teves said referring to Back To Service sa Kongreso formed by Cayetano in January.

Teves added that the game plan of Cayetano’s camp was to make Velasco “look bad in the eyes of President Duterte by attacking the Speaker on an issue very close to the Chief Executive’s heart—the pension and gratuity pay of police and military retirees.”

Deputy Speaker Lito Atienza, meanwhile, blasted Cayetano’s group for hypocrisy following the revelation of Deputy Speaker Isidro Ungab that the Cayetano-led House manipulated the 2020 national budget, which resulted in budget cuts totaling P209 billion, including the P70 billion slashed from pension and gratuity fund.

“Umaalma sila sa binawas na P20 billion na napunta naman sa COVID-19 response ng gobyerno pero ‘yung P70 bilyon at kabuuang P209 bilyon na tinapyas nila sa 2020 national budget e okay lang sa kanila,” said Atienza.

Defensor said it is not true that the P20 billion went to purchase COVID-19 vaccines.

He said that based on the copy of the General Appropriations Act, the budget for vaccines remained at P2.5 billion.



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