CategoryTurkey

BioNTech, Pfizer start rolling EMA approval filing for COVID-19 vaccine

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BioNTech and Pfizer have started a rolling submission of their COVID-19 vaccine BNT162b2 to the European Medicines Agency (EMA). The news comes days after EMA named AstraZeneca’s AZD1222 as the first COVID-19 vaccine to start the rolling review process.

The EMA uses rolling reviews to start assessing data on an experimental candidate before all the evidence needed to make a final decision is available, cutting the time it takes to decide whether to approve a prospect once the pivotal clinical trial results are submitted to the agency. The pressing need for COVID-19 vaccines potentially makes the mechanism important to the current crisis.

After receiving the first part of a rolling submission, the EMA’s Committee for Medicinal Products for Human Use has begun evaluating the preclinical evidence on mRNA vaccine BNT162b2. The rolling review format provides opportunities to file additional data before the complete application. Each cycle typically requires a two-week review. The duration of the review of the final application will depend on the proportion of data already assessed by EMA under the rolling review. 

The EMA accepted BNT162b2 for rolling review on the strength of the preclinical and early clinical data on the vaccine. BioNTech and Pfizer have linked BNT162b2, which encodes a SARS-CoV-2 spike glycoprotein, to antibody and T-cell responses in people dosed in early-phase trials. The data led the partners to start a phase 3 clinical trial.

That trial has now enrolled around 37,000 participants at sites in countries including the U.S., Brazil, South Africa and Argentina, with centers in Turkey coming online to help push BioNTech and Pfizer to their enrollment target of 44,000 subjects. More than 28,000 participants have received their second dose. BioNTech and Pfizer originally planned to enroll 30,000 subjects.

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Airport Covid testing to be given go-ahead ‘within days’ says MP – which could end quarantine restrictions

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Airport coronavirus testing could be given the go-ahead within days – which may end or drastically reduce quarantine periods.

Chief Secretary to the Treasury Stephen Barclay confirmed that decisions regarding new measures which include airport swabbing will be made in the “coming days”.

He also said it would be a similar procedure currently seen in Germany, where passengers arriving from high-risk countries are able to be tested, meaning they can leave the quarantine, according to the Times.

Speaking during a Conservative conference, Mr Barclay explained: ““I am expecting Grant Shapps and Matt Hancock to say more about this in the coming days.

“If we look, for example, at some of the German states, which are using testing to then release earlier from some of the restrictions.”

Brits currently have to quarantine for 14 days if returning from any countries deemed high risk, which includes Spain, France, parts of Portugal and Greece, the Netherlands and Turkey, which was added to the quarantine list last week.

https://www.thesun.co.uk/travel/12847172/airport-covid-testing-start-quarantine-rules-end/​

Turkey reports downward trend in virus deaths, infections

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Turkey reported a continued downward trajectory in COVID-19 deaths and confirmed infections Tuesday, with 28 new deaths and 1,022 infections over the past 24 hours.

Health Minister Fahrettin Koca tweeted new figures showing a total of 4,199 deaths and 151,615 reported positive cases since March 11, when the first infection was confirmed.

Turkey has opted for partial lockdowns, contact tracing and early treatment in combating the novel coronavirus. Fifteen provinces, including Istanbul, are in the final day of a four-day lockdown.

President Recep Tayyip Erdogan said Monday he hoped the upcoming nationwide lockdown during the Muslim holiday of Eid al-Fitr from May 23-26 would be the final round.

https://abcnews.go.com/International/wireStory/turkey-reports-downward-trend-virus-deaths-infections-70768152HELP US SPREAD GOOD NEWS!

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