China Corona virus pill: China conditionally approves Pfizer’s Covid treatment pill Paxlovid

China’s medical products regulator has conditionally approved Pfizer’s Covid-19 drug Paxlovid, making it the first oral pill specifically developed to treat the disease cleared in the country.

The National Medical Products Administration said Paxlovid had been approved to treat adults who have mild to moderate Covid-19 and who are at high risk of progressing to a severe condition. Further study on the drug needed to be conducted and submitted to the authority, it said.

Read more at: China conditionally approves Pfizer’s Covid treatment pill Paxlovid | China | The Guardian

EU Vaccine sales and distribution: EU begins to clamp down on vaccine exports as supplies fall short - by Michael Le Page

The European Union has taken a first step towards clamping down on the export of coronavirus vaccines after pharmaceutical firm AstraZeneca told the bloc it would deliver far fewer doses than expected in the next months. The EU hasn’t stopped manufacturers from selling to outside nations, including the UK, but has taken a step towards this by requiring vaccine manufacturers to give notice before exporting.

“In the future, all companies producing vaccines against covid-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries,” said Stella Kyriakides, the EU commissioner for health, on 25 January. “Humanitarian deliveries are, of course, not affected by this. The European Union will take any action required to protect its citizens and rights.”

Even before it was clear whether any vaccine would work, many countries signed deals with vaccine-makers to provide set numbers of doses by certain dates. As part of these, countries paid in advance for the preparation of manufacturing facilities.
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AstraZeneca was meant to deliver 80 million doses of its vaccine to the EU by the end of March. The EU hasn’t yet approved this vaccine, but is expected to do so soon.

Last week, AstraZeneca told the EU that it would only be able to deliver 31 million doses. According to Reuters, this is because the EU doses are being made at a vaccine factory in Belgium run by a company called Novasep that has faced production problems.

Read more at: "EU begins to clamp down on vaccine exports as supplies fall short | New Scientist

Vaccine distibution Logistics: Pfizer & BioNTech Experience Early Vaccine Shipping and Distribution Hiccups - by Mark Terry

On Tuesday, the Pfizer-BioNTech vaccine was granted temporary authorization in the UK and dosing will begin next week. The FDA has scheduled an advisory committee meeting for next week, December 8, 9 and 10, for the Pfizer-BioNTech product and potentially could grant approval on December 10, or within a few days afterward. The Moderna’s advisory committee meeting is scheduled for December 17.

The companies, including AstraZeneca-University of Oxford, which is running a close third, as well as the numerous others who have COVID-19 vaccines in development, have astonished skeptics by the speed with which they have developed vaccines that appear to be safe and effective. But now comes an even more daunting challenge—scaling up manufacturing and distribution to deliver the vaccine to populations around the world in a timely and effective manner.

In November, Pfizer and BioNTech had indicated it expected to transport half the COVID-19 vaccine it had originally planned for the year. That didn’t go quite as hoped.

“Scaling up the raw material supply chain took longer than expected,” a company spokeswoman told The Wall Street Journal. “And it’s important to highlight that the outcome of the clinical trial was somewhat later than the initial projection.”

Pfizer-BioNTech had original plans to roll out 100 million vaccines globally by the end of this year, but are now saying 50 million. They still believe they can manufacture more than a billion doses in 2021, enough for about 500 million people.

Read more at: a href="https://www.biospace.com/article/covid-19-vaccine-approval-is-one-challenge-manufacturing-and-distribution-quite-another/">Pfizer & BioNTech Experience Early Vaccine Shipping and Distribution Hiccups | BioSpace

EU: Coronavirus -Remdesivir: Commission signs a joint procurement contract with Gilead for the supply of Remdesivir

 The Commission has signed a joint procurement framework contract with the pharmaceutical company Gilead for the supply of up to 500,000 treatment courses of Veklury, the brand name for Remdesivir, and the opportunity to increase supply beyond the 500,000 treatment courses. There are  36 signatories of the Joint Procurement Agreement participating in this joint procurement, including all EU countries, the EEA countries of Norway and Iceland*, the UK, as well as six candidate countries and potential candidates (Albania, the Republic of North Macedonia, Montenegro, Serbia, Kosovo** and Bosnia and Herzegovina). All participating countries can now place their orders to procure Veklury directly. Veklury is at this stage the only medicine with a conditional marketing authorisation in the EU for the treatment of COVID-19 patients needing oxygen supply.

Read more at: Coronavirus: Remdesivir

EU Coronavirus: EU struggles to keep goods moving amid border closures

The coronavirus has so far tested health care systems and economies. But if borders continue to close, it will be a test for the single market, too.

Read more at:
https://www.euronews.com/2020/03/19/eu-struggles-to-keeps-goods-moving-amid-border-closures