VAKCINA

On 20 January a tweet by the Sputnik V Twitter account said “Sputnik V and European Medical Agency teams held the Scientific Review of Sputnik V on Jan 19.”

It added that the Russian Direct Investment Fund (RDIF), which is funding development of the vaccine, had “filed for Sputnik V registration in the EU and expects it to be reviewed in February. Based on these reviews EMA will decide on the authorization of Sputnik V for the EU.”

The same day the RDIF circulated an email confirming that a “Scientific Review was held yesterday between Sputnik V and EMA scientific teams. Over 20 top international experts and scientists took part in the review.”

Recommendations "based on the results of the Scientific Review are expected to be sent to the Sputnik V team in 7-10 days," the RDIF said, adding that it had “filed a registration application and expects the first Rolling Review to be held in February.”

It would be highly unusual for a registration application to be filed at the point where the developer has asked for scientific advice, a process that is designed to establish the requirements for a future marketing authorization application (MAA). Moreover, the head of the RDIF, Kirill Dmitriev, said last week that a formal MAA would be filed with the EMA in February. (Also see "Coronavirus Notebook: EMA Data Hack Aimed At 'Undermining Trust' In Vaccines, Russia Plans EU Sputnik V Filing Next Month" - Pink Sheet, 18 Jan, 2021.)

Asked to clarify the situation, the EMA told the Pink Sheet said that “at this stage, the developer has submitted a request for scientific advice to the Agency. The scientific advice process is a well-established process at EMA, which is available to all companies to facilitate the preparation of their development program.”

Under the process, the EMA “will provide advice to companies taking into account the latest regulatory and scientific guidance,” a spokesperson for the agency said. “As a next step the application for a marketing authorization could then be prepared by the company.”

The spokesperson added that “a meeting with the developer took place yesterday to discuss their development plan and their further engagement with the Agency. However, we cannot disclose the details of such conversations or other pre-submission activities because this information is confidential.”

Any scientific advice provided on a product under development will be included on the EMA’s list of COVID-19 medicines and vaccines that have received such advice.

The EMA spokesperson stressed that at this point “Sputnik V is not undergoing a rolling review. EMA will communicate at the start of a rolling review procedure.” The RDIF did not immediately reply to a request for comment.

Marius Lăcătuș wrote:Merkel je pominjala doslovce proizvodnju ruske vakcine u Nemačkoj za potrebe nemačkog tržišta, tim rečima.

Ulrike Demmer, the deputy spokeswoman for the German government, commented on the possibility of producing the Russian vaccine against the novel coronavirus "Sputnik V" in Germany at a briefing on Wednesday.

The production of the Russian vaccine "Sputnik V" in the EU would only be possible after the serum is approved by the European Medicines Agency (EMA), Demmer said.

German Chancellor Angela Merkel noted that bilateral cooperation aimed at expanding European production capacity in the manufacture of vaccines is possible, the government spokeswoman added. She was responding to a question about the content of the recent telephone conversation between Merkel and Russian President Vladimir Putin. More information on the issue is available from the EMA, it said.

Earlier, the Kremlin press service announced that Merkel and Putin on Jan. 5 discussed cooperation in combating the coronavirus pandemic and focused on prospects for joint production of vaccines. They agreed to continue contacts in this regard between the health ministries and other specialized institutions of the two countries.

Balkan nations turn to China and Russia for jabs
Shut out by Europe, aspiring EU members are looking east for coronavirus vaccinations

Valerie Hopkins in Budapest 12 HOURS AGO


As rancour builds in the EU over delays to its coronavirus vaccination rollout, Serbia has sped ahead to achieve continental Europe’s highest per capita inoculation rate.

But the Balkan state — a candidate to join the bloc — is not using jabs manufactured in the west. Serbia instead has turned to China’s Sinopharm, becoming the first European country to use the company’s shots and its neighbours are set to follow Belgrade’s lead.

“The world has hit an iceberg, like the Titanic, and the rich and the richest only save themselves and their loved ones,” Serbian president Aleksandar Vucic said last week, justifying his decision to purchase Chinese and Russian jabs while also negotiating contracts for EU-approved ones.

“We’re drowning together with the Titanic. It may not be their intention, but it is not particularly important to them.”

Although the EU has provided €70m to the six Balkan aspiring members to purchase vaccines, procurement problems in Europe mean that four of them have yet to receive any shots months after inoculation began in other countries. Frustrated, some are now looking east to Russia and China to secure scarce supplies.

Some officials warn it could also damage the EU’s credibility in the region. “Someone might use the situation and say that in times of hardships it is China and Russia that help, while the western governments are failing,” said an official in North Macedonia.

Unlike most regional leaders, Serbia’s strongman president has pursued close relations with Beijing and Moscow in tandem with its EU accession process, which has displeased Brussels and Washington.

Serbia, a country of 7m, has already received more than 1m doses, and Mr Vucic said on Saturday that another million would arrive before the beginning of March.

Belgrade’s approach is gaining traction among other countries in the region that had placed their faith in the EU’s distribution plan.

Neighbouring Kosovo and Bosnia and Herzegovina, as well as Nato allies North Macedonia and Montenegro, have still not received a single dose. Officials in Skopje and Podgorica announced last week they were going to buy vaccines from Russia and China.

“We wanted to go for western vaccines to show where we as a country belong, and initially excluded the possibility of negotiating with the Russians and the Chinese,” the official from North Macedonia told the Financial Times. 

But he said his government was having an increasingly hard time justifying delays. “Since there are other countries in Europe like Hungary who are getting [the Sinopharm vaccine], it would be difficult to explain to people why we are waiting for Pfizer, Moderna and AstraZeneca,” he said, referring to three companies manufacturing EU-approved vaccines.

Montenegro’s health minister Jelena Borovinic Bojovic said that in addition to a recently-signed contract for 150,000 Chinese inoculations, she would seek 50,000 doses of Russia’s Sputnik vaccine. The Bosnian government said in mid-January that it would start negotiations with Moscow, Beijing and Pfizer. Both countries had been waiting on supplies promised by Covax, the multilateral vaccine alliance, that have yet to arrive.

The EU had exempted the Balkans from a new ban on exports of vaccines to non-EU countries. But the bloc’s inability to send even symbolic doses to its aspiring members disappointed them, according to Adi Cerimagic, an analyst at the European Stability Initiative, a think-tank.

“They didn’t expect to receive it at the same time as EU member states, but they expected some kind of a clear timeline, clear arrivals, and now they feel like they are being abandoned,” he said.

In Albania, however, historical mistrust of China and Russia outweighs disappointment in Europe. Albania emerged three decades ago from one of Europe’s most repressive dictatorships, which for many years had been backed by Beijing. Prime Minister Edi Rama said he would steer clear of procuring Russian or Chinese jabs due to a lingering wariness.

But Mr Rama said he was disappointed that his country — which joined Nato in 2009 — had not received even symbolic doses through EU mechanisms. Albania plans to start vaccinating health workers next week with a batch of 970 BioNTech/Pfizer jabs donated by an anonymous European country.

“When it came to the vaccine, I was very badly surprised,” he told the FT in an interview. “It’s not that they [the EU] are in the best shape and they are turning their back to us. It is a whole mess . . . The harm they are doing to themselves is incredible.” 

https://www.ft.com/content/7508a3eb-c36b-4f6b-bd13-4a3a248b0686

plavaivy wrote:mog tatu pozvalo na Fajzera....nemam pojma kako..

Летећи Полип wrote:Čekaj, zar nisu oni nekad bili dobri s Kinom?

Erős Pista wrote:Insert nation balls comic here.

Prognosis

China Is Helping a European Ally Get Ahead on Vaccines

Serbia is leveraging its relationship with the east to inoculate more people than anywhere else in continental Europe.

By Misha Savic and Andrea Dudik
February 2, 2021, 12:00 AM GMT+1 Updated on February 2, 2021, 9:24 AM GMT+1

Serbian President Aleksandar Vucic puts his country’s status as continental Europe’s frontrunner in getting vaccines into people down to one thing: looking east as well as west.

The Balkan country may look like an unlikely success story as the neighboring European Union gets mired in a fiasco over vaccinations. Yet Serbia’s history of balancing its geopolitical interests is paying off at a critical time.

Serbia has been an important bridge for China to gain a foothold in Europe, while the country is also a traditional ally of Russia and is aspiring to join the EU. Those relationships have allowed it to diversify vaccine sources and inoculate a bigger proportion of its population than any other nation in Europe after the U.K. Serbia has injected 6.8% of its 7 million people, more than twice the ratio in the EU.

Most of the 1.1 million doses imported by the government in Belgrade so far have come from China’s state-backed Sinopharm. Vucic says his refusal to join a chorus of leaders criticizing China at a security conference in Germany helped him establish good relations with Foreign Minister Wang Yi.

“I was the only one who didn’t accuse China of anything so we had a brotherly meeting—the foreign minister and me—and since then the Chinese support began for us, concerning the coronavirus and everything else,” Vucic said in a televised address to the nation last week.

The speedy rollout of injections to combat Covid-19 relative to the EU underscores the tension across the continent, and also the potential geopolitical consequences in its most volatile region. Already, the Serbian approach has its followers within the EU: neighboring Hungary became the first member of the bloc to approve shots made by Russia and China.

Serbia’s goal is to join the EU, though with an electorate already divided over membership, the pandemic risks pushing the country into the orbit of rival powers. Meanwhile, Belgrade has promised vaccine donations to Kosovo and Bosnia-Herzegovina, exposing the divisions again in former Yugoslavia that fueled the bloody wars of the 1990s.

The EU has pledged to give six prospective members in the western Balkans—including Serbia—70 million euros ($85 million) to buy Covid shots, but deliveries are facing delays. Instead of waiting for the EU’s help, Belgrade secured vaccine from China, Russia and the U.S. directly.

French President Emmanuel Macron acknowledged the problems Europe is having with rolling out vaccine programs before a lunch with Vucic in Paris on Monday. “I would have wished that France, Europe could have been more present on your side on the topic of vaccines,” Macron told Vucic and a group of reporters. “We Europeans must be even more efficient on this.”

The former information minister to the late strongman Slobodan Milosevic, Vucic called in favors when the Covid-19 crunch began, securing ventilators and protective equipment in the early stages of the contagion. He then ordered vaccines from three suppliers: Sinopharm, Russia’s Gamaleya and Pfizer-BioNTech.

Details on the Chinese and Russian vaccines are less transparent than the western ones, though health authorities in Serbia have sought to assure citizens that all the shots in use are safe and effective.

A week ago, Vucic said he met with China’s ambassador and “literally begged her,” for more deliveries. “Knowing President Xi, I believe that before May or June we’ll receive significant quantities of new vaccines from China.” Serbia is also now looking to start local production of the Russian vaccine.

The Serb leader controls the government and has tightened his grip on power in 2020 elections with a landslide victory, amid a boycott by some opposition parties that accuse him of autocracy. His pitch to voters, though, includes his ability to forge relationships across the geopolitical spectrum, with little regard to the feathers he might ruffle along the way.

In June, Vucic drew condemnation from pro-EU politicians for kissing the Chinese flag when an airplane delivered medical gear from Beijing to Belgrade. At the time he described the promise of solidarity from the EU, by far the biggest contributor of aid and investment to Serbia, as “a fairytale on paper.”

Providing vaccines to Serbia gives an important geopolitical win for China as it faces up to a less fractious and more Sino-skeptic West under U.S. President Joe Biden. In recent years, China has focused investment on infrastructure in the Balkans through its Belt and Road Initiative, including a rail link between Belgrade and Budapest in Hungary.

There is a perception of China being more prepared to help than the EU, said Faris Kocan, a foreign policy researcher at the University of Ljubljana. “It started with mask diplomacy and the narrative continues with vaccines, despite the fact that Balkan nations are strategically dependent on EU,” he said.

Serbia started to vaccinate on Dec. 24, days before the EU. It has contracts for 6.5 million vaccines, but the global scramble for jabs is hurting confidence that the deals will be honored, Vucic said. No vaccines have come through the multinational Covax initiative, which the Balkan state also joined early on.

German Chancellor Angela Merkel held crisis talks on Monday with pharmaceutical executives and European Commission officials as part of efforts to speed up the stuttering vaccination push. The EU’s 27 states collectively have inoculated 2.9% of the population compared with 14.7% in the U.K. and 10% in the U.S., according to Bloomberg’s Vaccine Tracker.

“People in the EU are good people, but luckily I had enough experience and knowledge to assume that it would turn out like this,” Vucic said. “This is a war for people’s lives but also for the future of every country.”

— With assistance by Ania Nussbaum, Peter Martin, Andrew Langley, and Jan Bratanic

Na konstataciju novinarke [javnog servisa ARD koja ju je intervjuisala] da Srbija vakciniše brže od Nemačke i da li je problem ako su zemlje izvan EU u tome brže, [kancelarka Angela] Merkel je odgovorila da je tačno da Srbija brže vakciniše.

"Srbija vakciniše brže, kineskom vakcinom. Mi smo uvek govorili da je svaka vakcina koja dobije dozvolu Evropske agencije za lekove (EMA) dobrodošla. Razgovarala sam sa ruskim predsednikom o tome, i čula danas dobre vesti o ruskoj vakcini. Svaka vakcina je dobrodošla u EU, ali će biti prihvaćene samo one koje daju sve potrebne podatke EMA", rekla je Merkel.

Ona je ukazala da Evropska komisija nije želela da preuzme odgovornost nad vakcinacijom, jer je u prošlosti politika morala da preuzima odgovornost, što ovaj put nije željeno.

"Borimo se za poverenje u vakcine. Do kraja trećeg kvartala, rekla sam i ranije, ćemo svim građanima ponuditi vakcinu", naglasila je ona.

Moscow gains new leverage with coronavirus vaccine breakthrough
Europe risks being caught short once again in its vaccine strategy.

BY CARLO MARTUSCELLI AND HELEN COLLIS
February 2, 2021 9:41 pm

When news broke last August that Russia was the first country to approve a vaccine against the coronavirus, it was met with raised eyebrows around the globe.

The shot — named Sputnik V — hadn’t gone through the standard testing regime. Experts warned that the rushed process risked undermining public confidence in the shot. Meanwhile, media reported that production snags were delaying its rollout.

Impressive late-stage clinical trial results published in one of the world’s most prestigious medical journals Tuesday, however, have provided a sought-after endorsement from the scientific community.

The news that the jab is as effective as the West’s best efforts provides reason for cheer in regions like the Middle East and South America, where some countries have approved the vaccine — but it also could dog EU officials trying to hold together a coalition that has become embittered over the bloc's contested vaccine strategy and sluggish vaccine rollout.  

As countries like Hungary and Serbia — and maybe Germany — seek alliances with the Russian developer, EU citizens may want to know why leaders didn't engage with Moscow from the start for the broader sake of public health.

The study in the Lancet, above all else, establishes the vaccine as a serious contender with an efficacy rate of about 92 percent. The figure was arrived at by comparing the number of people infected with coronavirus in the vaccinated group (14,964 subjects) with a control group given a placebo (4,902 subjects).

Measurement of coronavirus infections started when the second dose was administered, 21 days after the first dose. Researchers recorded 16 cases of symptomatic COVID-19 in the vaccine group versus 62 cases in the placebo group. Importantly, there were no cases of "moderate or severe" coronavirus infections in the vaccinated group.

Global roadshow

The results will embolden countries on the EU's periphery, like Serbia and Belarus, that bet on the Russian vaccine. And it already has a taker within the EU: Hungary, which approved Sputnik V on January 22. (Budapest used an emergency authorization process allowing EU states to bypass rules that new biologically derived treatments should only be assessed centrally by the European Medicines Agency.)

POLITICO contacted every medicines agency in the EU and the European Economic Area. Among those who responded — Belgium, Slovakia, Croatia, Latvia, the Netherlands, Estonia, Ireland and Spain — none said they had had any contact with the Sputnik team. And none intend to.

“For the time being, there are no plans for directly obtaining Sputnik V vaccine,” said Ivana Šipić Gavrilović, spokesperson for the Croatian medicines agency HALMED.

Because the vaccine is derived from biotechnology processes, she said, a "centralized procedure is compulsory for its marketing authorization in the EU."

"Therefore, we are closely following the situation regarding the vaccine’s possible authorization through the said procedure, which would provide an equal and high level of safety for all European citizens," she added.

“We will follow the EMA,” said Dony Potasse, spokesperson for the Dutch drugs agency MEB.

A spokesperson for Russia’s sovereign wealth fund responsible for promoting the shot abroad, the Russian Direct Investment Fund, suggested otherwise, claiming that bilateral talks with unnamed countries in the EU — in both the east and west — are going forward.

To date, Hungary had only received small batches to use in clinical trials. But Reuters reported the first delivery of 40,000 doses was due to arrive Tuesday, citing a public television interview with Foreign Minister Peter Szijjarto.

While some have balked at the Hungarians’ solitary approach, others think the EU has wasted time for political reasons — and lost time fighting the virus and preventing more deaths.

One is Bavaria's premier Markus Söder, who said over the weekend that EU regulators should urgently review the Russian and Chinese vaccines, clearing them for use if they are safe and effective. German Health Minister Jens Spahn made a similar remark, suggesting they should be used all across Europe if they’re safe. Chancellor Angela Merkel, meanwhile, discussed manufacturing Sputnik at a German facility on a recent call with Russian President Vladimir Putin.

The looming question, then, is timing of EU approval. The RDIF spokesperson said Tuesday that talks with the European Medicines Agency — responsible for signing off on any vaccine used in the EU — are ongoing. The Sputnik team is sending a ream of data to the regulator, with the start of the review expected to be announced later this month.  

Who will buy?

Sputnik could prove to be a valuable lifeline for many countries. According to the Sputnik team, the shot is sold at less than $10 a dose, far cheaper than the mRNA vaccines made by BioNTech/Pfizer and Moderna — but still more than the price of a similar adenovirus vaccine from Oxford/AstraZeneca, which costs between $4 and $5 a dose.

Importantly, because the Sputnik vaccine uses adenoviral vector technology, it's stable at 2-8 degrees Celsius and therefore easier to deal with than the mRNA vaccines, which need extremely cold storage. This could prove to be a boon for less wealthy countries like Bulgaria, which didn't want to purchase vaccines that required ultra-cold storage, according to media reports.

Indeed, one RDIF official told journalists Tuesday that the shot was designed with accessibility in mind, as the necessary infrastructure for mRNA vaccines wasn’t guaranteed to be in place in far-flung Siberia.

Should Budapest start overtaking its neighbors in vaccination while the rest of the EU struggles, the Sputnik jab could prove irresistible to countries in the neighborhood that have somewhat warmer relations with Moscow, driving a further wedge in the European Commission’s vaccine strategy.

One former Czech health minister has already argued that it's wrong to ignore Sputnik, and that the country should consider obtaining some of the vaccine for its own population.

However, this all depends on the amount of vaccine that Russia can manufacture. RDIF didn’t reveal how much production is currently online, but said it's aiming to produce 1 billion doses by the end of the year — enough for 500 million people. It has production agreements with a number of countries outside of Russia, including India, Korea and Brazil. Manufacturing in China will start in February.

But Simona Guagliardo, health policy analyst at the European Policy Centre, cautioned that it’s important to understand the weight that the EMA's sign-off has.

“The procedures put in place by the EMA aim to create trust in vaccines,” she explained. “This isn’t a small detail if we think about how Europe is the global epicenter for vaccine hesitancy.”

Global ambitions

Up until now, Sputnik V — along with China’s Sinovac and Sinopharm — has been seen as the only route to vaccination for low- and middle-income countries. Unable to afford vaccine deals with big pharmas on one hand, and under-served by the global COVAX facility on the other, these nations have been turning to Russia and China — potentially at the expense of quality.

The fact that these vaccines were being bought up before their efficacy was proven is merely an indicator of countries’ desperation, said Kate Elder, senior vaccines policy adviser at Doctors Without Borders.

Tuesday's Lancet report, therefore, may come as some relief to both these countries and clinicians like Elder, who want to see equal access to quality vaccines for all.

Theresa Fallon, director for the Centre for Russia Europe Asia Studies, is clear in her assessment: The Russian vaccine has joined a “prestigious club of three global vaccines which are confirmed to be more than 90 percent effective.”

“Competition is good, even in vaccinations, and the sooner vaccination programs are rolled out, the sooner the world can recover from this pandemic,” Fallon said.

https://www.politico.eu/article/russia-sputnik-v-coronavirus-vaccine-breakthrough-leverage/

plachkica wrote:91,6!

BREAKING: Russia’s coronavirus vaccine, Sputnik V, is 91.6 percent effective, according to a peer-reviewed study published today in the medical journal The Lancet.

The data comes from a Phase 3 study of almost 20,000 participants. https://t.co/R3XrbrNmLr

— POLITICOEurope (@POLITICOEurope) February 2, 2021