Manufacturers deliver less Vaccination campaign could stall

Status: 16.06.2021 2:47 p.m. In Germany there will be fewer BioNTech cans available next month. Johnson & Johnson is also delivering less than planned. The German vaccination campaign could suffer a setback as a result. The vaccine manufacturer BioNTech will deliver significantly less vaccine to Germany in July than in June. Instead of 5.7 million cans for the last week of June, only 3.2 million cans are planned for the first week of July (KW 27). But there could be no question of a surprising cut, said a spokesman for the Federal Ministry of Health. Rather, BioNTech preferred deliveries in June that were actually intended for later. It was always clear that the delivery volume of the Mainz manufacturer in the third quarter would be around 40.2 million vaccination doses lower than the around 50 million in the second quarter. So far there has only been a clear delivery promise for the first week of July with 3.235 million cans. After that, around 3.3 million doses per week can be expected. That was also communicated to the federal states. SPD health expert Karl Lauterbach therefore warns of a setback for the vaccination campaign: “If the BioNTech deliveries fall so sharply, it will be difficult to demonstrate herd immunity before mid-September,” he told the “Spiegel”. At the same time, it is shown that the delta variant is highly infectious and sometimes causes severe disease. “That’s scary,” said Lauterbach.

06/02/2021

6.5 million fewer doses from Johnson & Johnson

The US pharmaceutical company Johnson & Johnson (J&J) will also deliver significantly fewer vaccine doses than planned. The European Commission expects that J&J will not be able to meet its delivery targets to the EU for the second quarter. The reason for this is a decision by the European Medicines Agency (EMA), according to which 17 million doses of the vaccine cannot be used in the EU for safety reasons after cases of contamination have occurred in a US plant. The group will therefore probably not reach its delivery target of 55 million cans by the end of June, says a commission spokesman. So far, only around twelve million cans have been delivered. The Federal Ministry of Health estimates that J&J will be able to deliver around 6.5 million fewer doses to Germany than planned by the end of June because of the breakdown. “That is unfortunate, because every vaccine counts,” said a spokeswoman. The ministry expects the missing quantity to be replenished in July.

June 16, 2021

Waiting for Sputnik and Curevac

The Germans will probably have to wait even longer for the Russian vaccine Sputnik V, because, according to government circles, approval will be postponed “probably to September, maybe even to the end of the year”. The reason is that the Russian manufacturer has not yet submitted the necessary clinical trial data to the European Medicines Agency (EMA), the news agency Reuters learned from government circles. The clinical dossier was supposed to be available by June 10th. The Russian state fund RDIF, which sells Sputnik V, described the information as incorrect. All the necessary data on the clinical studies have been submitted and received positive comments. Initially, no comments were received from the EMA. The vaccine from Curevac is also not yet available. The vaccine from the Tübingen company, once praised as a bearer of hope, is still not approved. The Federal Ministry of Health has therefore canceled the delivery of 1.4 million vaccine doses originally planned for the current second quarter. According to health expert Lauterbach, the delay in approval could indicate that the effectiveness of the Curevac vaccine is not looking good.

06/07/2021

Moderna delivers a little more

Meanwhile, there are increasing complaints about the shortage of vaccines – from company doctors, general practitioners and some vaccination centers. The calls from some prime ministers for more vaccine also persist – while millions of Germans are still waiting for an initial vaccination. There is positive news from Moderna: The US manufacturer will increase its delivery volume compared to June, from 622,000 to 733,000 cans per week. In addition, Schleswig-Holstein is giving part of the AstraZeneca vaccine provided by Denmark to Hamburg. Thanks to the delivery, at least 8,000 new appointments can be made in the vaccination center in the megacity since today. The neighboring state does not manage to use the cans from Danish stock in time before the expiry date at the end of June.

background June 15, 2021

This is the third COVID-19 vaccine that has been urgently approved by Vietnam, after the AstraZeneca and Sputnik V vaccines. COVID-19 vaccine (Vero Cell), Inactivated is prepared as an injectable suspension, each dose of 0.5 ml contains 6.5U of inactivated SARS-CoV-2 antigen. The name of the production facility, the country of production is Beijing Institute of Biological Products Co.,Ltd. – China. This vaccine was licensed by China on December 24, 2020, and was urgently approved by WHO in May. The approval of the COVID-19 vaccine (Vero Cell) Inactivated serves an urgent need in the prevention and control of the COVID-19 epidemic with conditions attached. Specifically: The vaccine was approved based on safety, quality and effectiveness data provided by the Central Institute of Hygiene and Epidemiology to the Ministry of Health as of May 29, and the commitment of the Central Hygiene and Epidemiology Committee. about the accuracy of the documents provided to the Ministry of Health. The Central Institute of Hygiene and Epidemiology is responsible for coordinating with manufacturers, ensuring the conditions for vaccine production imported into Vietnam and ensuring safety, effectiveness and quality. The Institute cooperates with the Department of Science, Technology and Training (Ministry of Health), and qualified units to organize the evaluation of the safety and effectiveness of vaccines. The Central Institute of Hygiene and Epidemiology cooperates with the National Institute for Accreditation of vaccines and medical biologicals to develop an inspection plan, to provide test samples, materials, testing chemicals and other related issues for customers. testing batches of these vaccines before they are put into use. The Central Institute of Hygiene and Epidemiology is also the unit responsible for guiding the storage, distribution and use of this vaccine for vaccination facilities, and at the same time coordinating with relevant units in implementing risk management. for this vaccine during its circulation in Vietnam. The use of this vaccine must follow the instructions of the Ministry of Health.

According to Saxony’s Prime Minister Michael Kretschmer, Germany wants to purchase 30 million doses of the Russian vaccine Sputnik V. “We want to buy three times ten million cans – in June, July and August – Sputnik V,” said the CDU politician after a conversation with Russian Health Minister Mikhail Muraschko in Moscow. The prerequisite, however, is approval by the European Medicines Agency. EMA approval forms the necessary basis of trust. It would be a great success if approval were granted in May, said Kretschmer. There is currently an EMA delegation in Moscow. The Russian Minister of Health has assured that they want to achieve this approval together. “The minister is in good spirits, and so are we.”

Kretschmer: Great approval in Saxony

Kretschmer assumes that the Russian vaccine will enjoy great approval in Saxony. If the delivery works, the federal state would receive 500,000 cans in each of the three months according to the distribution key of the federal states. “We will see whether the approval everywhere is as high as in Saxony and the new federal states for the vaccine – maybe we will get more then,” said Kretschmer, alluding to possible reservations in western federal states. Kretschmer himself wants to be vaccinated with the AstraZeneca vaccine in the coming week. He deliberately wanted to show that this vaccine was safe, he said. On Wednesday, Chancellor Angela Merkel criticized the fact that some EU countries were already using Sputnik V without EMA approval. Health Minister Jens Spahn announced negotiations on the purchase after countries such as Bavaria and Mecklenburg-Western Pomerania had negotiated independently with the Russian manufacturer. In Germany, the federal government is responsible for the procurement of vaccines.

By Ivo Marusczyk, ARD studio Buenos Aires The Russian vaccine Sputnik V is now also manufactured in Argentina. According to the Russian investment fund, which markets the vaccine worldwide, the first batch was produced in a laboratory in Buenos Aires.

Production for Argentina and Latin America

These cans are now to be checked for quality in Moscow. If all goes well, production on a larger scale could start in June. In Argentina, the vaccine for vaccinations in their own country and in other countries in Latin America will then be produced. The raw materials still come from Russia Vaccine is still scarce in much of the continent. Only Chile was able to vaccinate 40 percent of its population with at least one dose. The AstraZeneca vaccine was also manufactured under license in Argentina. But so far it cannot be used – the bottling should take place in Mexico, but is not progressing.

Production of Sputnik V Russia has its Sputnik V corona vaccine produced in several countries, including India. According to the Russian state fund RDIF, which is responsible for marketing the vaccine, agreements were concluded with 20 producers in ten countries by the beginning of April. These include South Korea and China. According to RDIF, there are also agreements with partners in Germany, France, Spain and Italy. However, some of the national governments declared that they were not aware of the relevant agreements.

Sharply increasing number of cases

In Argentina, the number of new corona cases has recently risen sharply. Since Sunday, the Robert Koch Institute has classified the country as an area with a high incidence. For a few days, there has been a curfew from 8 p.m. in the Buenos Aires area, restaurants are actually only allowed to serve outdoors. The central government and the city government of the capital are fighting a violent dispute over the closure of the schools.

From Peter Allgaier, BR A high fence, barbed wire and a lot of forest – from the road you can see very little of R-Pharm in Illertissen. But the Bavarian state government has high hopes for the company in the Neu-Ulm district. 2.5 million doses of the Sputnik V vaccine is to be supplied by the company with which a preliminary contract has already been concluded, emphasized Bavaria’s Prime Minister Markus Söder last week . He wants to alleviate the vaccine shortage in vaccination centers and doctors’ offices. But when and whether R-Pharm can deliver the promised quantity is open.

It is currently unclear whether R-Pharm can deliver the promised quantities. Image: REUTERS On the one hand, this is due to the vaccine’s approval for Europe. The location in Illertissen provided a corresponding one in February Application to the European Medicines Agency (EMA) in Amsterdam. Their employees traveled to Russia last Monday to visit production sites there. They also toured two clinics where patients were cared for during clinical trials.

Doubt despite study too high effectiveness

The medical journal “The Lancet” Sputnik V certifies a high level of effectiveness , similar to that of the vaccines from BioNTech / Pfizer or Moderna. But there are also doubts. According to the Slovak Medicines Agency the vaccine that was supplied is different from the one that “The Lancet” rated. However, R-Pharm is struggling with other problems in Illertissen. There are no permits from the Neu-Ulm district for the planned expansion of the company. A construction freeze on the site was the result.

The process in Illertissen is to be accelerated

“We can only approve a fire protection concept or an application under immission control law if they are on the table,” says Franz-Clemens Brechtel, the deputy district administrator. In immission control, for example, it is checked what effects a system has on the flora and fauna, but also on air and water quality. A specially established task force and a project manager are now supposed to ensure that the procedures are accelerated and run more smoothly. Illertissen has a long tradition in the manufacture of chemical products. In 1860 Heinrich Mack bought an oil mill and made bath tablets there. In the 1930s, the physician Karl August Forster then built one of the largest beekeeping farms in Europe with more than 100 million animals on the site. A rheumatoid drug called “Forapin” was made from their poison. The bee culture is still visible in the city today, in a specially set up museum in the city’s castle.

R-Pharm took over the location in 2014

The US company Pfizer then took over the site in the 1970s. The company had drugs packaged, but also drugs made with highly effective substances. The company was particularly at the forefront of what is known as “containment”, a process in which employees do not come into contact with the active ingredient. But that could not prevent the loss of jobs. Around 350 people are currently still employed by the company, which was finally taken over by R-Pharm in 2014.

The municipality has great hopes for production

“The vaccine production would be like winning the lottery,” says Jürgen Eisen. He is mayor of Illertissen, a town with around 17,000 inhabitants, many of whom share his opinion. They hope for good jobs and more income for the place. R-Pharm is currently advertising vacancies: Among other things, specialists in biotechnology are being sought. More than 30 million euros are to be invested in the expansion, according to the Russian company in a press release. In addition to Sputnik V, the manufacturer could also produce AstraZeneca in the future. Corresponding plans have been circulating for six months. But much is still in the balance.

Possible start of production unclear

R-Pharm can currently only produce on the so-called pilot plant scale, that is, try out the individual steps in a small test arrangement and, for example, produce samples for customers. It is unclear when the correct production can start. The government of Upper Bavaria announced that R-Pharm has not yet submitted an application to be allowed to manufacture the vaccine. The authority sees the urgency in the face of the pandemic, but emphasizes – like the district office – the rule of law. The basis is that all necessary documents are available and the requirements are met.

Time is running out

R-Pharm in Illertissen, however, is running out of time. There are still too few vaccine doses nationwide. However, the situation could change in just a few months. Because established manufacturers are expanding their production, others such as the US company Novavax or the French manufacturer Sanofi are trying to get approval. In the end, it could be similar to FFP2 masks. At first there was far too little, but now the copies are piling up at the dealers. The vaccine is likely to be needed in many other, especially poorer countries, also because the vaccine is comparatively cheap.

AstraZeneca’s COVID-19 vaccine. Photo: AFP/TTXVN

According to the Ministry of Health, the man was injected with a vaccine produced at India’s Serum Institute. The patient has returned home and is in the process of recovering.

Earlier, Canada limited AstraZeneca’s vaccine use to people over the age of 55 due to concerns about the rare reaction. The above information is the latest challenge for vaccination in Canada.

In addition, Health Canada confirmed that it is in discussions with Johnson & Johnson about the possibility of a COVID-19 vaccine. The department has asked Johnson /Johnson for information on any cases of post-injection blood clots. The agency is also working with the U.S. Food and Drug Administration (FDA) and other international agencies on the issue.

Although Canada has licensed Johnson&Johnson’s vaccine, the vaccines ordered will not be shipped until the end of April. Canada is expected to get enough vaccines so that by the end of June, each citizen can get one shot. However, the rate of spread of the new variants of the SARS-CoV-2 virus is surpassing the progress of vaccination in the country.

The number of new cases in the last week has increased by 33%, while the number of new daily infections is at more than 8,100, equivalent to the peak of the second wave of outbreaks earlier this year. Canadian Prime Minister Justin Trudeau warned more dangerous new variations were spreading rapidly and threatened progress had been made.

According to statistics worldometers.info, Canada has a total of over 1 million infections and over 23,000 deaths from COVID-19.

* Meanwhile, Australia announced that it will send Trade Minister Dan Tehan to Europe on April 15 amid reports that it has ordered more than 3 million doses of AstraZeneca’s vaccine made in the European Union (EU) but has not received the goods.

Under the plan, Minister Tehan will have dialogues with his German, French and EU colleagues to discuss eu production and export limits on AstraZeneca’s vaccines.

Australia is one of the countries that succeeds in controlling the COVID-19 epidemic. Since the outbreak, the country has recorded nearly 30,000 cases. However, Australia is currently behind in its vaccination campaign. As of April 11, Australia had only vaccinated nearly 1.2 million people, despite a pledge by the end of March to vaccinate 4 million people.

The Australian government believes that the EU’s non-delivery of the vaccines it ordered by AstraZeneca was the cause of the delay in the vaccination program, but state authorities pointed out that the distribution of vaccines to health facilities also contributed to this situation.

Under pressure from public opinion, Australian Prime Minister Scott Morrison said he would convene a cabinet meeting twice a week with state and territory leaders until the issue was resolved and put the vaccination program back on track.

Australia intends to vaccinate the majority of the population with AstraZeneca’s vaccine, which has imports from Europe and domestic production, while waiting for supplies from Pfizer and Novavax. The Australian government recently admitted it may not meet its target for COVID-19 vaccination for all residents next October due to import delays and new concerns about vaccine side effects.

* In Ireland, Health Minister Stephen Donnelly said the country is considering extending the vaccination period between Pfizer/BioNTech’s two doses to more than 4 weeks to maintain the vaccination progress, amid concerns that other vaccines such as AstraZeneca and Johnson /Johnson are being restricted from use due to safety risks.

In Russia, President Vladimir Putin confirmed he had given two shots against COVID-19. Speaking on television, Mr Putin expressed hope people would do the same to take care of themselves and their loved ones.

On March 23, President Putin received his first shot of the COVID-19 vaccine.

The Kremlin did not specify the type of vaccine the Russian President was vaccinated against, but insisted it was among three Russian-developed vaccines including Sputnik V, EpiVacCorona and CoviVac. In the interview, Mr Putin said he had suffered minor side effects such as muscle pain after his first injection but did not have a fever.