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A big step on the road to the long-awaited anti-corona active ingredient: Mainz-based company BioNtech and US pharmaceutical giant Pfizer have applied for emergency approval for their corona vaccine from the US pharmaceutical authority FDA. Pfizer confirmed this on Friday on Twitter. The companies had previously announced that approval applications were being prepared for Europe and other regions.
“We can deliver in a matter of hours if we get a permit,” said a BioNtech spokeswoman in Mainz. If the active ingredient is approved, particularly vulnerable people in the US could be vaccinated in mid to late December.
“A decisive step”
BioNtech CEO and Co-Founder Ugur Sahin spoke of a “decisive step in making our vaccine candidates available to the world’s population as quickly as possible.” The goal is the rapid worldwide distribution of the vaccine. “As a German-based company in the heart of Europe”, close contact with the European Medicines Agency (EMA) is of particular importance to BioNtech.
BioNtech and Pfizer are the first Western manufacturers to publish promising study results and are paving the way for emergency FDA approval. According to the company, an extensive series of tests for the vaccine with the designation BNT162b2 showed effectiveness offering 95 percent protection against Covid-19 disease. The vaccine works equally well in all age groups and other demographic differences and shows virtually no serious side effects, the companies announced after their final analyzes.
The FDA must first review the application after it has been submitted. It was initially unclear how long that might take. However, the American experts were sure that there could be an audit result before the end of the year. An expedited approval process is applied to corona vaccines due to their particular urgency.
BioNtech and Pfizer are already sending data to the European Medicines Agency (EMA) and other countries. In this way, manufacturers can transmit partial information on the quality, safety and efficacy of a preparation even before the formal application for approval. “We are continually submitting data in a continuous submission process,” the BioNtech spokeswoman replied when asked about preparations for the vaccine approval applications at the EMA and in Switzerland. The objective is to use this data to allow the approval of an application.
A first vaccine could be approved in Europe from the second half of December, the head of the EU Commission, Ursula von der Leyen, said on Thursday, referring to information from the EMA.
A plant in the city of Marburg in Hesse will play an important role in the production of the vaccine. The acquisition of this production plant from the Swiss pharmaceutical company Novartis was completed in October, according to BioNtech.
After production, the doses of the vaccine must be distributed “evenly” according to the company. “One country will not achieve everything.” Germany and the EU have already signed a framework agreement for the purchase of 300 million doses of the vaccine from BioNtech and Pfizer. Based on delivery forecasts, BioNtech assumes that up to 50 million doses of vaccines will be shipped worldwide this year and that up to 1.3 billion doses will be manufactured next year.
BioNtech had already started developing the BNT162b2 vaccine in the “Lightspeed” project in mid-January. The phase 3 study, which is crucial for its approval, began in late July.
The preparation is a so-called mRNA vaccine, which is based on a new mechanism. It contains genetic information about the pathogen, from which the body produces a virus protein, in this case the surface protein with which the virus enters cells. The goal of vaccination is to stimulate the body to produce antibodies against this protein to intercept viruses before they enter cells and multiply.
An advantage of mRNA vaccines is that they can be produced much faster than conventional vaccines. However, the vaccine must be stored at minus 70 degrees. Pfizer has extensive experience in refrigerated storage and vaccine transportation and already has a corresponding global infrastructure, the companies said.
In addition to BioNtech / Pfizer, several other pharmaceutical companies are currently working on advanced-stage corona vaccines, including Johnson & Johnson, Astrazeneca, and Sanofi-GSK. In Russia, China and recently in Bahrain, vaccines with restrictions have already been launched, and vaccinations have started there. However, little is known about how well these active ingredients actually protect and what side effects they may have.
German Health Minister Jens Spahn recently stated that he expected a speedy approval process. At the same time, he announced an extensive information campaign on corona vaccination. First of all, the elderly, people with previous illnesses, doctors and nurses, police officers, firefighters, teachers and educators should be vaccinated, in accordance with the recommendations of the German Ethics Council, the Academy of Sciences of Leopoldina and the Permanent Commission on Vaccination.
Vaccine in January in Austria?
The Covid Special Representative in the Ministry of Health, Clemens Martin Auer, said in the lunch diary Ö1 that the first vaccines can arrive in Austria from January. However, this depends on the European approval authority. Even if this is not certain yet, it is realistic that there will be approval this year. “In any case, we are in a position to organize that when the first deliveries arrive in January, we will also start vaccinating in Austria.”
The first amounts would not be so large, but in a first phase the residents of the nursing homes and for the elderly would be vaccinated, then the personnel there and in the hospitals and the entire health sector. For the summer, along with the other vaccinations, anyone who wants it could be protected. Auer dashed hopes that the first vaccines would immediately return to normal. However, with a vaccination coverage of 50, 60 percent, the probability of a new block is very low.
Trump accuses drug companies of deliberately delaying vaccination
US President Donald Trump has accused the pharmaceutical company Pfizer of deliberately delaying the release of data on its future corona vaccine to harm it in the election. “Pfizer and others have even decided not to test the results of their vaccines, in other words, just to get a vaccine out immediately after the election,” Trump said at a press conference at the White House on Friday. “You have waited and waited and waited.”
Originally, drug companies wanted to submit their data in October, Trump said. “But they decided to postpone it.” The reason is his plans to cut drug costs, which he unveiled on Friday, Trump said. Therefore, he had turned the pharmaceutical industry against him.
If drug companies had announced their good results on the effectiveness of their candidate vaccines before the Nov. 3 presidential election, “it probably would have had an impact” on the election, Trump said. At the same time, he again claimed that he had actually won the election anyway.
Pfizer and German partner BioNtech announced on November 9 that their corona vaccine candidate was more than 90 percent effective. On November 16, the American biotech company Moderna announced that its vaccine candidate was 94.5 percent effective. Pfizer and BioNtech, which are now talking about 95 percent effectiveness, filed an application with the US FDA on Friday for an emergency approval that could be granted in a few weeks.
Trump said on Friday that the drug lobby had already spent “millions of dollars” on advertising against him during the election campaign. “We had Big Pharma against us.” He spoke of “corrupt games”. The president-elect did not respond to questions from journalists.
Trump has yet to admit his electoral defeat against Democrat Joe Biden. The headline speaks of an alleged electoral fraud. Election authorities and experts strongly disagree, emphasizing that Biden legitimately won the election.
The vaccine euphoria faded again
US stock exchanges bid farewell to the weekend with price losses. This is the third time they have posted price losses in the last four business days. At the start of the week, the Dow Jones had risen to a record thanks to the hope of another promising crown shot. But then, given the large number of corona infections, a bit of disappointment set in on the market.
On Friday, the Dow Jones fell 0.75 percent to 29,263.48 points. The market-wide S&P 500 lost 0.68 percent to 3,557.57 units. The high-tech Nadasq composite was unable to sustain its slight gains and fell 0.42 percent to 11,854.97 points.
Dispute over financial aid from Corona
Additionally, a dispute between the Treasury Department and the Federal Reserve over financial aid from the crown is causing a bad mood among investors. This is funding that the government has used to support various central bank aid programs. The ministry wants to recover the funds and phase out some of the central bank’s programs. The central bank is reluctant to do this and calls for continued aid.
News from the company on price movement was rare before the weekend. Biontech’s shares rose more than nine percent, Pfizer’s 1.3 percent. The German company and the US pharmaceutical giant had announced that they would apply to the US FDA for emergency approval for their BNT162b2 corona vaccine on Friday. Biontech had already announced that delivery could start later this year, if there was a permit. Biontech and Pfizer are the first Western manufacturers to publish promising study results a week and a half ago and want to apply for emergency FDA approval.
The titles of competitor Moderna, which a week later had released good data on its vaccine, were up more than 5 percent. EU Commission Head Ursula von der Leyen said the Biontech and Pfizer vaccines, as well as Moderna’s, could get conditional marketing approval in the second half of December, if all goes smoothly. The European Medicines Agency announced.
By contrast, Foot Locker shares fell nearly five percent despite good trade figures. Yet right at the start of the stock market, stocks of sporting goods manufacturers had reached their highest level in a year.(what / dpa / afp)
