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EU envoy says Russia delays EMA Sputnik V vaccine inspections - media

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A health-care worker prepares a dose of Sputnik V (Gam-COVID-Vac) vaccine against the coronavirus disease (COVID-19) at a vaccination centre in Gostiny Dvor in Moscow, Russia July 6, 2021. REUTERS/Tatyana Makeyeva/File Photo

Russia has repeatedly delayed inspections by the European Medicines Agency (EMA) necessary for the certification of its Sputnik V COVID-19 vaccine in the European Union, the EU's ambassador to Moscow was quoted as saying on Friday (8 October), Reuters, write Olzhas Auyezov, Anton Zverev and Andrew Osborn in Moscow and Jo Mason in London.

The Sputnik V vaccine, widely used in Russia and approved for use in more than 70 countries, is undergoing a review by the World Health Organization and the EMA.

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Russia has accused the West of refusing to certify its flagship vaccine for political reasons. Without EMA approval, it is harder for Russians to travel throughout the EU.

"This is a technical rather than a political process," EU ambassador Markus Ederer told Russia's RBC media outlet in an interview.

"When Russian officials talk about the process being delayed and politicised by the European side, I sometimes think they are largely referring to themselves because it is them who makes this about politics."

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Russia’s sovereign wealth fund, the Russian Direct Investment Fund (RDIF), markets Sputnik V overseas. It declined to comment.

The EMA said it could not immediately comment on the matter.

Five people with knowledge of European efforts to assess the drug told Reuters earlier this year that the developers of Sputnik V had repeatedly failed to provide data that regulators deem to be standard requirements of the drug approval process. read more

RDIF said at the time that Reuters’ reporting contained “false and inaccurate statements” based on anonymous sources who were attempting to harm Sputnik V as part of a disinformation campaign.

Russian Health Minister Mikhail Murashko said this month that all the barriers to register Sputnik V with the WHO had been cleared and that only some paperwork remained to be completed. read more

The TASS news agency cited the health ministry as saying on Friday that EMA inspectors might carry out a visit to Russia in December.

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Pfizer begins study of oral drug for prevention of COVID-19

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Pfizer Inc (PFE.N) said on Monday (27 September) it has started a large study testing its investigational oral antiviral drug for the prevention of COVID-19 infection among those who have been exposed to the virus.

The drugmaker and its rivals, including US-based Merck & Co Inc (MRK.N) and Swiss pharmaceutical Roche Holding AG (ROG.S), have been racing to develop an easy-to-administer antiviral pill for COVID-19. Read more.

The mid-to-late-stage study will test Pfizer's drug, PF-07321332, in up to 2,660 healthy adult participants aged 18 and older who live in the same household as an individual with a confirmed symptomatic COVID-19 infection.

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In the trial, PF-07321332, designed to block the activity of a key enzyme needed for the coronavirus to multiply, will be administered along with a low dose of ritonavir, an older medication widely used in combination treatments for HIV infection.

To date, Gilead Sciences Inc's (GILD.O) intravenous drug remdesivir is the only approved antiviral treatment for COVID-19 in the United States.

Pfizer has also started another study of PF-07321332 in non-hospitalized, symptomatic adult patients.

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Merck and partner Ridgeback Biotherapeutics recently launched a late-stage trial of their experimental drug molnupiravir for prevention of the COVID-19 infection. Read more.

Molnupiravir is also being studied in a late-stage trial in non-hospitalized patients to see if it reduces the risk of hospitalization or death.Reporting by Manojna Maddipatla and Amruta Khandekar

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EU Digital COVID Certificate: Commission awards €95 million to boost access to tests

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The Commission has awarded grants to 20 member states totalling €95 million to purchase COVID-19 diagnostic tests to facilitate the delivery of the EU Digital COVID Certificate. This goes hand-in-hand with the continued roll-out of COVID-19 vaccinations and is part of the Commission's commitment to support affordable access to fast and accurate testing for those citizens who have not yet been fully vaccinated, in particular those who cannot get vaccinated due to medical reasons.

The grants, financed through its Emergency Support Instrument (ESI), will allow member states to provide tests. This support, channelled through the national authorities, will cater for the various needs in the different member states. Health and Food Safety Commissioner Stella Kyriakides said: “The EU Digital COVID Certificate allowed Europeans to resume safe travelling over the summer and has become a symbol of an open and safe Europe. Whilst vaccination is key and our strongest asset to put an end to the pandemic, fast and accurate testing remains important to tackle the spread of COVID-19. The 20 million rapid tests we purchased for member states earlier this year and today's announcements of additional funds prove that we stand firm on our commitment to ensure that citizens have access to tests and that our digital certificates are available for everyone, in particular those who cannot get vaccinated.”

Justice Commissioner Didier Reynders said: “Over 400 million Europeans have so far benefited from the Certificate, and 42 countries are already linked to the EU certificate system. This is a major European achievement which has been highly valued by our citizens. Today's grants will further contribute to the use of the certificates and ensure that people can continue to move freely and safely. I welcome this decision and I call on the 20 member states to make the best use of those additional tests.”

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The ESI provides a needs‐based, co-ordinated emergency response to help member states address needs related to the immediate acute phase of the COVID-19 pandemic, as well as the exit, recovery and prevention of any resurgence.

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US-EU agenda for beating the global pandemic: Vaccinating the world, saving lives now, and building back better health security

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Vaccination is the most effective response to the COVID pandemic. The United States and the EU are technological leaders in advanced vaccine platforms, given decades of investments in research and development.

It is vital that we aggressively pursue an agenda to vaccinate the world. Co-ordinated US and EU leadership will help expand supply, deliver in a more coordinated and efficient manner, and manage constraints to supply chains. This will showcase the force of a Transatlantic partnership in facilitating global vaccination while enabling more progress by multilateral and regional initiatives.

Building on the outcome of the May 2021 G20 Global Health Summit, the G7 and US-EU Summits in June, and on the upcoming G20 Summit, the US and the EU will expand cooperation for global action toward vaccinating the world, saving lives now, and building better health security.  

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Pillar I: A Joint EU/US Vaccine Sharing Commitment: the United States and the EU will share doses globally to enhance vaccination rates, with a priority on sharing through COVAX and improving vaccination rates urgently in low and lower-middle income countries. The United States is donating over 1.1 billion doses, and the EU will donate over 500 million doses. This is in addition to the doses we have financed through COVAX.

We call for nations that are able to vaccinate their populations to double their dose-sharing commitments or to make meaningful contributions to vaccine readiness. They will place a premium on predictable and effective dose-sharing to maximize sustainability and minimize waste.

Pillar II: A Joint EU/US Commitment to Vaccine Readiness: the United States and the EU will both support and coordinate with relevant organisations for vaccine delivery, cold chain, logistics, and immunization programs to translate doses in vials into shots in arms. They will share lessons learned from dose sharing, including delivery via COVAX, and promote equitable distribution of vaccines.

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Pillar III: A Joint EU/US partnership on bolstering global vaccine supply and therapeutics: the EU and the United States will leverage their newly launched Joint COVID-19 Manufacturing and Supply Chain Taskforce to support vaccine and therapeutic manufacturing and distribution and overcome supply chain challenges. Collaborative efforts, outlined below, will include monitoring global supply chains, assessing global demand against the supply of ingredients and production materials, and identifying and addressing in real time bottlenecks and other disruptive factors for global vaccine and therapeutics production, as well as coordinating potential solutions and initiatives to boost global production of vaccines, critical inputs, and ancillary supplies.

Pillar IV: A Joint EU/US Proposal to achieve Global Health Security. The United States and the EU will support the establishment of a Financial Intermediary Fund (FIF) by the end of 2021 and will support its sustainable capitalization.  The EU and United States will also support global pandemic surveillance, including the concept of a global pandemic radar. The EU and the United States, through HERA and the Department of Health and Human Services Biomedical Advanced Research and Development Authority, respectively, will cooperate in line with our G7 commitment to expedite the development of new vaccines and make recommendations on enhancing the world's capacity to deliver these vaccines in real time. 

We call on partners to join in establishing and financing the FIF to support to prepare countries for COVID-19 and future biological threats.

Pillar V: A Joint EU/US/Partners Roadmap for regional vaccine production. The EU and the United States will coordinate investments in regional manufacturing capacity with low and lower-middle income countries, as well as targeted efforts to enhance capacity for medical countermeasures under the Build Back and Better World infrastructure and the newly established Global Gateway partnership. The EU and the United States will align efforts to bolster local vaccine manufacturing capacity in Africa and forge ahead on discussions on expanding the production of COVID-19 vaccines and treatments and ensure their equitable access.

We call on partners to join in supporting coordinated investments to expand global and regional manufacturing, including for mRNA, viral vector, and/or protein subunit COVID-19 vaccines.

More information

Joint statement on the launch of the joint COVID-19 Manufacturing and Supply Chain Taskforce

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