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The vaccine developed by the German company Biontech and the US company Pfizer shows a protection of 95 percent. The application for emergency approval is to be submitted in the USA shortly. Production will start this year.
BioNTech, a biotech company based in Mainz (Germany), and its U.S. partner Pfizer have cleared the decisive hurdle for a possible approval of their corona vaccine in the U.S. After a final analysis of the pivotal study, the vaccine has shown a 95 percent protection against Covid 19 infection, the two companies announced on Wednesday. They also published positive data on the safety of the vaccine, which they called a milestone for emergency approval in the U.S. They plan to submit the application for this to the US Food and Drug Administration (FDA) within a few days. The data will also be submitted to other regulatory authorities worldwide.
Last week, Biontech and Pfizer were the first companies to submit successful efficacy data from the pivotal study with a corona vaccine. After a first interim analysis, the vaccine showed an efficacy of more than 90 percent in protecting against Covid-19, and on Monday the U.S. biotech company Moderna followed suit and announced that its vaccine offers 94.5 percent protection against Covid-19.
The U.S. Food and Drug Administration (FDA) had set an efficacy of 50 percent as the minimum value for a possible approval. Regarding safety, the FDA issued new guidelines for emergency approval in October, with safety data expected to be available for at least two months from about half of the study participants after the last dose of vaccine. The final analysis of the Biontech and Pfizer study, which involves more than 43,000 participants, is based on 170 Covid-19 cases among the subjects. Of these, 162 occurred in the placebo group and only eight in the vaccinated group. There had been ten severe cases of Covid-19, only one in the vaccinated group.
The vaccine was well tolerated and there were mostly mild to moderate side effects that subsided quickly. The only serious adverse event was fatigue in more than two percent of vaccinated participants, with 3.7 percent experiencing fatigue after the second dose. Protection was uniform regardless of age and ethnic origin. In older adults over 65, the observed effectiveness was over 94 percent.
“The data show that our 30 microgram vaccine can provide high protection against Covid-19 only 28 days after the first dose,” said Biontech CEO Uğur Şahin, a Turkish-born scientist and physician who founded the company in 2008 together with his wife Özlem Türeci, the German-born daughter of a Turkish doctor.
The vaccine is administered twice with a dose of 30 micrograms each. The dose is lower than that of the Moderna vaccine with 100 micrograms each. The vaccine of the Tübingen biotech company CureVac, which like those of Biontech and Moderna is based on the so-called messenger RNA (mRNA), will even be tested with a dose of only 12 micrograms. However, Curevac’s pivotal study has not yet started.
Biontech and Pfizer have confirmed that they intend to produce up to 50 million doses of vaccine this year and up to 1.3 billion doses in 2021, while the EU has secured up to 300 million doses, with delivery expected to begin at the end of this year. The U.S. has signed a contract with the companies for 100 million doses worth around $1.95 billion, including an option to purchase a further 500 million doses.
— hp with reports from diepresse.at. Picture: pixabay.com
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