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

The corona vaccine from the US manufacturer Johnson & Johnson (J&J) can be used without restriction in the EU after testing by the EU Medicines Agency (EMA). Although the active ingredient can cause blood clots in very rare cases, similar to the AstraZeneca vaccine, the benefits of the vaccine are greater than the risks. A corresponding warning should be attached. The US company’s corona vaccine has been approved in the EU since mid-March, but was not used due to possible serious side effects. Last week, the US authorities also advised a temporary suspension of vaccinations with the drug after the occurrence of isolated thromboses. J&J then postponed delivery of the vaccine to the EU, which had only started early last week. The vaccine was developed by the Belgian Johnson subsidiary Janssen. The EU Commission has already ordered 200 million vaccine doses from J&J. Germany would receive 36.7 million of this. It is the second time that the EMA is re-examining a corona vaccine after approval. Cerebral vein thrombosis had also occurred with the active ingredient from the Swedish-British manufacturer AstraZeneca, especially in younger women. The cases with the Johnson preparation are very similar to those with the Covid-19 vaccine from AstraZeneca, the experts have now also determined.

Annual forecast raised

In the first quarter, J&J made $ 100 million on its corona vaccine. 7.2 million doses of the vaccine, which was approved in the USA at the end of February, have so far been injected there, according to the company. J&J does not want to make any profits from it. Similar to AstraZeneca, the US company has also committed itself to producing its vaccine at cost price. Nevertheless, J&J, spurred on by good quarterly figures, has raised its forecast for the full year. According to this, the group is aiming for earnings per share of at least $ 9.42 instead of the previous $ 9.40. J&J is also more optimistic about sales than at the beginning of the year.

J&J makes vector vaccine

As with the corona vaccine from competitor AstraZeneca and the Russian vaccine Sputnik V, it is a vector vaccine. A so-called adenovirus is used as a vector. This usually triggers a common cold, but has been modified to prevent it from multiplying. The vector sends genetic instructions to the cells to produce a specific protein from the Covid-19 pathogen Sars-CoV-2. In this way, the immune system is prepared to fight the real corona virus. The J&J vaccine was initially considered a “real miracle weapon” because it can be stored at refrigerator temperature and one vaccine dose is sufficient to achieve a comprehensive immunization.

EMA thinks vaccine is safe

The EMA had previously confirmed that the vaccine could indeed cause blood clots in very rare cases. But the possibility of blood clots with a very low number of platelets is only registered as a rare side effect. According to the experts, most of the cases involved women under 60 years of age. Therefore, the authority reiterated that the benefits of the vaccine to prevent Covid-19 should be rated higher than the risks of side effects. It was the second time that the EMA re-examined a corona vaccine after approval. Cerebral vein thrombosis had also occurred with the active ingredient in AstraZeneca. Here, too, the EMA stuck to its assessment that the vaccine was safe.

36.7 million vaccine doses for Germany

In the EU, delivery of the Johnson & Johnson vaccine only started last week. Numerous EU countries followed the manufacturer’s recommendation to wait for the EMA experts’ report before using it. The EU Commission has already ordered vaccination doses for 200 million people. Of these, 36.7 million vaccination doses are to be delivered to Germany and thus accelerate the vaccinations. Nationwide, according to registration data, 20.2 percent of the population have now been vaccinated at least once, according to the Robert Koch Institute (RKI). According to this, around 16.8 million people were vaccinated once, and around 5.6 million more received full protection with a second dose. Ten of the 16 federal states have already reached the 20 percent mark for first vaccinations.

From Anja Martini, tagesschau.de

How did the delivery stop come about?

In the USA, a vaccination ban with the active ingredient from Johnson & Johnson has been imposed. The CDC and the FDA had recommended this exposure. The reason for this were noticeable side effects: Six people were diagnosed with sinus vein thrombosis – that is, cerebral vein thrombosis – between six and 13 days after the vaccination. In three cases, thrombocytopenia, i.e. a lack of blood platelets, also occurred. They are women between the ages of 18 and 48 years. The delivery of the Covid-19 vaccine to the European Union had only started on Monday. Johnson & Johnson has committed to delivering 55 million cans by the end of June, with a total of 200 million cans to the EU this year. Because of the reports of complications, the US manufacturer postponed its delivery to the EU countries.

How many doses of the vaccine did Germany expect?

According to previous delivery commitments, Germany expects around ten million doses of the Johnson & Johnson preparation for the second quarter. These are now canceled. A first delivery of more than 230,000 doses of the corona vaccine arrived at the Bundeswehr pharmacy in Quakenbrück (district of Osnabrück) on Tuesday. All corona vaccination doses for Germany will first be brought there. From there the vaccine should then be distributed to the federal states.

Are there now further vaccination delays in Germany?

Not clear. The SPD health politician Karl Lauterbach does not expect any lasting damage to the vaccination campaign in Germany. The thrombosis cases were to be expected after the cases with the similar vaccine from AstraZeneca, according to Lauterbach im Deutschlandfunk . He assumes that the complication is so rare that after a while the vaccine will be vaccinated again in the USA and the start of vaccination will then also begin in Europe. In Bavaria, for example, a spokesman for the state health ministry told the Reuters news agency that the provisional delivery stop would not require any changes to vaccination planning in Bavaria. The vaccine had not yet been fed into the vaccination logistics. This is different in Brandenburg: Also because 6,700 vaccine doses from Johnson & Johnson would not initially be delivered to Brandenburg, this exacerbates the already existing bottlenecks, said State Interior Minister Michael Stübgen. Appointments for first vaccinations would be stopped.

How is the EU reacting to the delivery stop?

The European Commission has ordered a total of 50 million additional doses of corona vaccine from BioNTech / Pfizer. They should be delivered by the end of June. BioNTech / Pfizer also agreed to deliver the cans scheduled for the fourth quarter as early as the end of April. The total delivery volume from Biontech / Pfizer for the second quarter increases to 250 million cans. These are distributed across the EU.

How does the Johnson & Johnson vaccine work?

The Johnson & Johnson vaccine is – just like that from AstraZeneca – a so-called vector vaccine. The genetic blueprint of part of the coronavirus is packaged in a weakened carrier virus that is not harmful to humans. This carrier virus brings parts of the genetic material of the virus into the cell. The human cell replicates these parts of the virus. The immune system reacts and makes antibodies. This makes Johnson & Johnson’s mode of action the same as that of the AstraZeneca vaccine. However, only one dose of vaccine is required for the Johnson & Johnson vaccine. All other active ingredients previously approved in Germany must be vaccinated twice.

What causes the thrombosis?

Scientists believe it may be related to the specific type of these vaccines. “The fact that both vaccines are based on the same principle and cause the same problems, in my opinion, suggests that the vector itself is the cause,” said Johannes Oldenburg from the Bonn University Hospital of the German Press Agency. However, this is speculative at the moment. It is theoretically also conceivable that the spike protein of the virus, which is presented to the immune system in all available vaccines for the formation of antibodies, causes the side effects, explained Oldenburg. It is also fundamentally possible that the side effects are triggered unspecifically as part of the general immune response. Clemens Wendtner, chief physician at Munich Clinic Schwabing, also suspects that the side effects of both vaccines are based on a similar mechanism. “In the case of Johnson & Johnson, we have the same side effects that we have with AstraZeneca,” says Wendtner. “The question arises as to whether there is a class effect here, in other words the adenoviruses that are used as vectors that trigger problems.” Scientists at the University Medical Center Greifswald suspect a possible cause of the complications that the thrombosis is a defense reaction of the blood platelets. This led to the formation of blood clots in the brain.

What were the consequences of similar side effects with AstraZeneca?

Rare cases of thrombosis in the past few weeks had sowed doubts about the AstraZeneca vaccine and led to a temporary stop of vaccinations with this agent. By April 8, 46 cases of sinus vein thrombosis after vaccination with the AstraZeneca vaccine (new name: Vaxzevria) had been reported to the Paul Ehrlich Institute, in 24 cases additionally thrombocytopenia. Five women and three men died. With the exception of seven cases, all reports concerned women between the ages of 20 and 66 years. The men were 24 to 58 years old. In Germany, this vaccine can now only be used without restriction in people aged 60 and over .

What are cerebral vein thrombosis?

Sinus vein thrombosis is blood clot in veins in the brain that drain blood from the brain. Symptoms can be headache, but also epileptic seizures, paralysis or speech disorders. According to the Paul Ehrlich Institute, the blood clots in the cerebral veins occurred together with thrombocytopenia, i.e. a lack of blood platelets. Platelets are also responsible for blood clotting. A lack of platelets leads to an increased tendency to bleed. Symptoms include punctiform bleeding into the skin or mucous membranes, and severe nosebleeds are also possible.

The US pharmaceutical company Johnson & Johnson is postponing the launch of its vaccine in Europe. Reports of sinus vein thrombosis have been received and the decision has therefore been made to delay, the company said. The cases would now be investigated with experts and the authorities. The US health authority CDC and the FDA had previously recommended a temporary suspension of vaccinations with the Johnson & Johnson active ingredient. Six people in the US were diagnosed with sinus vein thrombosis between six and 13 days after vaccination, the authorities said in a joint statement. In three cases, thrombocytopenia, i.e. a lack of blood platelets, also occurred. They are women between the ages of 18 and 48 years.

Inoculated more than 6.8 million doses

According to the authorities, more than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the United States to date. The vaccine, of which only one dose is sufficient for vaccination protection, received US approval at the end of February. The now recommended suspension of vaccinations is a precautionary measure until exact results are available, said the CDC and FDA.

No decision for Germany

A spokesman for the federal health department said they had not yet decided how to proceed after the US warnings. “We always take such warnings seriously and follow them up.” The spokesman also referred to the responsibility of the Paul Ehrlich Institute. The vaccine from Johnson & Johnson was also approved in the EU in mid-March, but, unlike in the USA, is not yet in use here. The EU Commission assumes that the vaccine will be delivered to the EU next week. A total of 55 million cans are to be delivered in the second quarter, a good ten million of them to Germany. The Johnson & Johnson vaccine is the second corona vaccine that is suspected to be associated with the occurrence of sinus vein thrombosis. Previously, some countries had temporarily suspended vaccinations with the AstraZeneca vaccine, including Germany.