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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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Commission proposes additional funding to support global vaccination and to respond to global emergencies

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The European Commission has proposed to amend the EU Budget 2021 to provide additional support to policy areas which need reinforcement in view of recent developments and additional needs. Concretely, this Draft Amending Budget 6 will help speed up global vaccinations. It will provide an additional €450 million to reach the €1.3 billion which are needed to secure an additional 200 million doses of vaccines against COVID-19 for low and middle-income countries through COVAX, as announced by President von der Leyen in her State of the Union speech. This Draft Amending Budget 6 also proposes reinforcing the EU Civil Protection Mechanism with €57.8m. The funds foreseen in the budget to address emergencies need to be increased to cover the costs of the response to the emergencies and natural disasters which occurred last summer, including repatriation flights for EU nationals based in Afghanistan, operations in Haiti following the recent earthquake and fighting forest fires in Europe. The Draft Amending Budget needs to be approved by the European Parliament and by EU member states in the Council. A Q&A with more information is available here.

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COVID-19 vaccination: MEPs call for EU and global solidarity

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The EU must continue its concerted efforts to fight the COVID-19 pandemic and take urgent measures to ramp up vaccines production to meet citizens’ expectations, MEPs say,  PLENARY SESSION ENVI.

In the plenary debate with the Portuguese Presidency and Commission President Ursula von der Leyen, MEPs commented on the state of play of the EU’s COVID-19 vaccination strategy.

Many members emphasized that the EU had made the right key decisions, especially on the collective European approach to vaccination and on standing up for its citizens’ rights by putting safety first and enforcing EU liability rules.

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President von der Leyen defended the EU’s choice to order vaccines collectively, the need for global solidarity and the decision not to take any shortcuts on the safety and efficiency of vaccines. Lessons must be drawn from past mistakes, she acknowledged, as “we are still not where we want to be in the fight against the virus”.

Solutions to exit the crisis must be found in the spirit of solidarity, between member states as well as at global level, MEPs underlined. The EU has a responsibility for the rest of the world and must ensure vaccines are fairly distributed across the globe, they added, reiterating that “nobody is safe until everybody is safe”.

Members acknowledged that the EU underestimated the challenges of vaccine mass production and that concrete measures to ramp up production must now be taken as a matter of utmost priority. Many MEPs urged the Commission to enforce existing contracts and at the same time support member states in their vaccine deployment strategies.

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In order to build citizens’ trust in the vaccination efforts and avoid disinformation, the EU must “tell the truth”, some MEPs pointed out. In this respect, many recalled the need for transparency with regard to contracts, as well as for comprehensive and clear data on vaccines rollout at national level.

Taking into account the large amounts of public money invested, several MEPs also called for increased parliamentary scrutiny of the implementation of the vaccines strategy.

Watch the video recording of the debate here. Click on the names below for individual statements.

Ana Paula Zacarias, Portuguese Presidency

Ursula von der Leyen, European Commission President (1st part2nd part3rd part)

Manfred Weber (EPP, DE)

Iratxe García Pérez (S&D, ES)

Dacian Cioloş (Renew Europe, RO)

Marco Zanni (ID, IT)

Ska Keller (Greens/EFA, DE)

Beata Szydło (ECR, PL)

Manon Aubry (The Left, FR)

Background

On 12 January 2021, MEPs quizzed the Commission on the latest developments regarding COVID-19 vaccines. A debate in plenary followed on 19 January focusing on the global EU strategy for COVID-19, while the Commission published an updated action plan to step up the fight against the pandemic on the same day.

During the plenary debate in January, MEPs expressed broad support for the common EU approach to fighting the pandemic and called for complete transparency regarding contracts and deployment of COVID-19 vaccines.

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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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