Tag: EU

Categories : COVIDTags :

Paxlovid Ramped up and No ‘Red Flags’ for Omicron Yet

On By ModernMedia
Image by Quicknews

In the face of a renewed global surge in COVID cases, Pfizer has ramped up production of Paxlovid, even while the efficacy of Merck’s molnupiravir appears to be less than believed.

Pfizer is now expecting to make 80 million courses of Paxlovid by the end of 2022, Pfizer CEO Albert Bourla told CNBC, a significant increase over its earlier planned capacity of 50 million courses.

This news came after Merck reported the risk reduction in hospitalisation and death from its COVID antiviral, molnupiravir, fell from 50% in the interim analysis to 30% in the final analysis. The reduction came after results were updated with participants that became evaluable after the interim analysis. This drop has led to predictions of increased demand for Paxlovid, which has shown an 89% risk reduction in outpatients.

The increase in production comes just in time to fight the Omicron variant, for which South Africa is now better prepared, according to experts.

‘No red flags’
According to Professor Salim Abdool Karim, director of the Centre for the Aids Programme of Research in South Africa, the numbers appear to be on the rise across all continents, but as yet there are “no red flags” he said.

Omicron has been identified by South African scientists as a major driver of the spike in cases in Gauteng.

“We have been amazed at how fast the numbers are going up,” he said. “But we were not caught with our pants down. We expected and prepared for a fourth wave. [The scientists] gave us the best fighting chance by giving us information early. We didn’t know exactly when it would come and what it would look like,” Prof Karim said, speaking to the Daily Maverick.

While a number of mutations enable the variant to escape immunity, a clear picture of Omicron’s nature won’t emerge for two to four weeks, he cautioned.

Speaking about travel bans imposed on South Africa by Mauritius, Rwanda, Egypt and the Seychelles, President Cyril Ramaphosa said ahead of a West African tour: “I am concerned. Out of due respect to them, they have their own reasons. We would like to have a discussion with them in a way we prefer that they do not react like our former colonisers who are very quick to close Africa down,” Ramaphosa told journalists.

EU accelerates child vaccinations
EU President von der Leyen has said that vaccines for children aged five to 11 will be available in the bloc by December 13, a week ahead of schedule and that she is pushing for the consideration of mandatory vaccination. This comes amidst news that Omicron was detected in the Netherlands before its first detection in South Africa. Meanwhile, in Asia, South Korea has reported its first five cases of Omicron.

Categories : COVID Lab Tests and ImagingTags :

Siemens COVID Antigen Test Kit Receives German Approval

On By ModernMedia

Siemens Healthineers announced on Wednesday that their antigen self-test kit, which uses samples from a nasal swab, has received limited special approval from the Federal Office for Drugs and Medical Devices (BfArM) for self-use by laypeople in Germany. The regular conformity assessment procedure for the standardised ‘CE‘ mark was also initiated for personal use by laypeople.

“With the provision of the COVID-19 antigen rapid test for possible use by laypeople in Germany, we are breaking new ground and are thus continuing to fulfill our social responsibility to support a return to normal social life,” said Bernd Ohnesorge, Head of Europe, Middle East, and Africa Regions, Siemens Healthineers

The practicability of the kit was confirmed by a study in which 50 participants without medical training personally carried out the test by following the instructions for use. The test already has a CE mark for use by specialist groups for taking samples in the nose.

“The CLINITEST COVID-19 Antigen Self-Test offers users a high degree of flexibility in performing the test with very good quality results,” said Christoph Pedain, Head of Point of Care Diagnostics at Siemens Healthineers.

Siemens’ COVID-19 Antigen Self-Test takes 15 minutes to give a result, using samples taken from both nostrils using a swab. The swab is then washed out in a reagent, which detaches a specific protein from the surface of the virus. The resulting liquid is dripped into a recess in the test cassette.

The test liquid migrates into the field of view of the cassette within 15 minutes, becoming visible as a line. The position and number of lines indicate as to whether there is a positive or negative test result, or whether there was a problem, necessitating a repeat of the test.

In the instructions, the tester is shown the steps to achieve a test result, including instructions on how to proceed according to the test result. A negative test result does not exempt the user from any local COVID regulations. Currently, the test kit is also available in the UK.

Source: Siemens

Categories : COVIDTags :

EU Angered by Pfizer Delay

On By ModernMedia

Pfizer has said in a statement on Friday that the drop in production is the result of the company upgrading its manufacturing processes, and that there will be an overall increase in supply as a result.

“Although this will temporarily impact shipments in late January to early February, it will provide a significant increase in doses available for patients in late February and March,” Pfizer said.

The German health ministry has said the delays are surprising and regrettable, pointing out that it had secured binding mid-February delivery dates from the company. EU Commission President Ursula von der Leyen said that she had been given assurances by Pfizer’s chief executive that all orders for the first quarter would arrive. She had previously said that Pfizer had promised to double its delivery of doses to the EU to 600 million this year.

However, the EU also has agreements in place with Moderna to supply vaccines, and this is not wholly dependent on Pfizer. However, Johnson & Johnson is also falling behind in its vaccine delivery targets, amidst reports that the US has failed to meet vaccination goals for the end of 2020, and may struggle to meet this year’s goals. Meanwhile, the UK is expected to be slightly impacted by the drop in supply but remains on track to meets its February immunisation goals.

However, the EU has lagged behind the UK in its vaccination programme, for a number of reasons including the fact that the UK ordered and approved its vaccines sooner, while Brussels’ negotiations were slower. Much of the delay is due to the added bureaucracy of the 27 nation political confederation and its decision to acquire vaccines as a single entity instead of individual countries further exacerbated this.

According to Reuters, citing a participant at a meeting last week, a third of the EU’s 27 countries reported difficulties in securing enough vaccines for their vaccination programmes.

Source: BBC News