Johson & Johnson vaccine nearing approval in – politics


The vaccine from the US pharmaceutical company Johnson & Johnson could still be approved for the European Union (EU) in March. On March 11, the European Medicines Agency (EMA) will review the vaccine for use in the EU, EMA CEO Christa Wirthumer-Hoche announced in a talk show on Austrian broadcaster ORF. “We expect a positive evaluation and that the EU Commission grants approval quickly.” On the other hand, there are not yet sufficient data for approval of the Russian vaccine Sputnik V. “That is why I would strongly advise against issuing a national emergency license,” explains Wirthumer-Hoche.

Von der Leyen promises 100 million vaccine doses per month across the EU

EU Commission President Ursula von der Leyen expects significantly more vaccines from next month. “From April the quantities could double again according to the plans of the manufacturers, also because more vaccines are about to be approved,” she said Stuttgart newspaper and the Stuttgart news (Monday). She reckons EU-wide “in the second quarter with an average of around 100 million doses per month, a total of 300 million by the end of June”. According to the newspapers, this would mean around 20 million doses a month for Germany, which would require significantly higher vaccination capacities.

According to figures from the Robert Koch Institute on Friday, around 7.3 million vaccine doses have been administered in Germany since vaccinations began at the end of December. Of almost 5 million people who were vaccinated, almost half also received the second vaccination.

The federal government classifies Greece as a risk area

Due to the increasing number of corona infections, the federal government has classified all of Greece as a corona risk area for the first time from Sunday. For parts of Croatia – including the Istria peninsula, which is very popular with holidaymakers – all entry restrictions due to the pandemic will be lifted at the same time, as the Robert Koch Institute announced on the Internet on Friday.

Due to the particularly high number of infections, Hungary, Sweden and Jordan are classified as high-risk areas. So far, Greece was one of the few countries that had never been fully classified as a corona risk area. Most recently, the Greek islands in the Aegean Sea, Crete and the Ionian Islands, including Corfu, off the west coast of Greece were excluded.

From Sunday, returnees from these regions will have to be tested for Corona within 48 hours of entering Germany. They also have to be in quarantine for ten days, from which they can only get rid of another negative test after five days.

Countries and regions in which the number of new infections exceeds 50 per 100,000 inhabitants in seven days (incidence) are designated as risk areas. Countries with an incidence of over 200 are considered high-risk areas. If you come to Germany from these regions, you have to show a negative test upon entry.

WHO rejects planned EU vaccination certificates

The World Health Organization (WHO) rejects the vaccination passports planned by the EU Commission. The introduction announced for the summer is “probably inevitable,” said the WHO / Europe regional director, Hans Kluge world. “But it’s not a WHO recommendation.” There are serious concerns: It is uncertain how long an immunity will last. Also, a vaccine “does not necessarily prevent the infection of other people”.

The EU Commission wants to present the draft law for a “digital green passport” on March 17th, which will record corona vaccinations, Covid diseases and negative tests. The aim is to find a safe way to lift restrictions and travel in Europe. The heads of state and government of the European Union had previously agreed to advance plans for a digital vaccination record. The technical requirements should be in place within three months so that people vaccinated against corona can prove their immunization across Europe in a forgery-proof manner.

Kluge expects the corona pandemic to end in around ten months. He assumes that 2021 will be another Covid year, 2020 will have been “Terra Incognita”. “A year later we know a lot more. That is why I assume that the pandemic will be over in early 2022.” Which does not mean that the virus is gone. “But hopefully there will be no more disruptive interventions.”

Kluge warned against not taking corona mutations seriously enough because some could spread very quickly and cause serious disease processes. “If this coincides with a slow vaccination campaign, then we lose the momentum. Then the virus can regain the upper hand.” Now is not the time for people in Europe to sit back and relax.

The WHO European Office announced on Thursday that the number of new infections in Europe had increased by nine percent. This stopped the promising decline of the last six weeks. Virus variant B.1.1.7, which first appeared in Great Britain, has now appeared in 43 of the 53 European countries.

Australia disappointed with vaccine delivery stop from EU

Australia has sharply criticized the delivery stop of corona vaccine from the European Union. “We are of course disappointed and frustrated with this decision, but that is also the reason why we have double coverage,” said Treasury Secretary Simon Birmingham on Friday Sky News. “We have commissioned up to 150 million doses of vaccine, including 50 million doses to be produced here in Australia,” he said. The world is currently in a fairly unexplored area, so it is not surprising that “some countries are going to tear up the rulebook”.

According to EU circles, Italy had prevented the delivery of 250,000 doses of vaccine from the British-Swedish manufacturer Astrazeneca to Australia – and thus for the first time stopped the export of corona vaccine from the European Union to a third country. At the end of January, the European Union started export controls for corona vaccines. The focus is on manufacturers who do not meet their EU delivery obligations. Now it’s Astrazeneca.

The basis is an export control system introduced at the end of January due to the shortage of vaccines. Accordingly, pharmaceutical companies with EU delivery obligations must apply for export permits for vaccines produced in the EU. If manufacturers unlawfully disadvantage the EU in terms of delivery quantities, permits can be refused. Astrazeneca does not meet the originally promised delivery volume to the EU in the first quarter, which has caused great resentment.

The EU member state in which the vaccines intended for export were produced is responsible for the export permits. The Italian Foreign Minister Luigi Di Maio wrote on Facebook: “Australia is now seen as a country that is ‘not at risk’ under EU rules”. The lock is “not a hostile act towards Australia”. Australia has recorded around 29,000 coronavirus cases since the pandemic began – a significantly lower per capita rate than most developed countries. The number of deaths is currently 909. Around 25 million people live in the country.

EU authority checks Russian vaccine

The European Medicines Agency EMA is now also investigating the Russian corona vaccine Sputnik V – the first step towards approval in the EU. The authority in Amsterdam has announced that it has started a so-called rolling review.

The Russian Gamaleja Institute for Epidemiology and Microbiology now has the opportunity to gradually submit its scientific findings on the effectiveness, safety and quality of the vaccine, said the CDU MEP and health politician Peter Liese. These data would be examined by the experts and if this scientific analysis were positive, an official application for approval for the European Union could be submitted.

Sputnik is the seventh corona vaccine to be tested in this way by the EMA. In addition to the three approved vaccines from Biontech / Pfizer, Moderna and Astra Zeneca and the vaccine from Johnson & Johnson, which is due for approval on March 11, the American company Novavax and the Tübingen-based company Curevac have long been involved in the Rolling Review at the EMA started.

Sputnik is already being used in Hungary because the local pharmaceutical authority has issued emergency approval. Such rapid approvals can only be issued by national supervisors and are only valid in the relevant country. The Sputnik manufacturer had already claimed in the past few weeks that it had applied for approval from the EMA. The Amsterdam authority had so far rejected this.

Mass vaccination against variant from South Africa in Tyrol

The South African variant of the corona virus is to be combated with a mass vaccination in the Austrian state of Tyrol. In a scientifically supported pilot project, the Schwaz district will be supplied with 100,000 doses of vaccine, which will be delivered with the help of the EU, the government announced in Vienna on Wednesday.

Exit tests were introduced for Tyrol in February in order to curb the widespread spread of the more contagious virus variant. “That worked very well,” said Federal Chancellor Sebastian Kurz. From a peak value of around 200 active cases, one has reached less than 100 cases. Nevertheless, one must continue to work on reducing the number towards zero. For most of Tyrol, it will still only be possible to leave the country with a negative test result.

Vaccination with the vaccine from Biontech / Pfizer is scheduled to begin among adults in Schwaz next week. The district has around 84,000 inhabitants. The aim of the campaign is to collect scientific knowledge about the effectiveness of this vaccine against the variant that was originally discovered in South Africa. In the rest of Austria, only very old people, health workers and teachers will be vaccinated for the time being.

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Poland has almost twice as many new infections as the day before

The number of new infections in Poland is increasing dramatically. According to the Ministry of Health, 15,698 new infections were reported within 24 hours, almost twice as many as the 7,937 reported the previous day. The Deputy Health Minister Waldemar Kraska said on the radio. “I don’t have good news. Today’s numbers show that the third wave is gaining momentum.” In the same period of time its 309 people died related to the coronavirus.

Kraska expressed concern at the increasing number of patients receiving treatment in hospitals for Covid-19. Currently there are more than 15,000. More than 1,500 ventilators are in use.

Poland had recently relaxed the corona restrictions, but announced that they would tighten them again if the number of cases increased. Poland has around 38 million inhabitants. Germany has classified the neighboring country as a risk area. So far, 2.2 million Poles have been vaccinated against the coronavirus, and almost 1.2 million have already received two doses of the vaccine.

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Johson Johnson vaccine nearing approval politics


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