Pfizer-BioNTech 2nd Covid Vaccine Shows Less Side Effects
Berlin – Istanbul-Pfizer and Biontech are making progress in their search for a vaccine against the Sars Cov-2 virus. Further data from an early phase we study with the drug candidate BNT162b2 turned out positive, the US pharmaceutical company and the Mainz biotech company announced on Thursday evening. In the test, the active ingredient ensured a strong response from the immune system in both younger and older patients.
The test subjects each received two doses of BNT162b1 or BNT162b2 with a dosage of 10, 20 or 30 µg at an interval of 21 days. In the phase I study in the USA, BNT162b2 induced Sars-CoV-2-neutralizing geometric mean values (GMT) that were 3.8 days after the second dose of 30 µg in younger adults between 18 and 55 years of age times the GMT of a panel of convalescence sera from 38 patients. In older adults between 65 and 85 years of age, the vaccine candidate induced a neutralizing GMT 1.6 times the GMT of the same panel, and also demonstrated strong immunogenicity in both younger and older adults.
As already announced by the companies, subjects vaccinated with BNT162b2 showed a more advantageous breadth of epitopes that are recognized in T-cell reactions that are specific for the Sars-CoV-2 spike antigen. In addition, BNT162b2 showed a simultaneous induction of high level CD4 + and CD8 + T-cell responses against the receptor binding domain (RBD) and the remainder of the spike glycoprotein.
Immunization with BNT162b2 was well tolerated in all populations, with mild to moderate fever in less than 20 percent of subjects. Systemic responses following vaccination with BNT162b2 were less than the responses seen with BNT162b1. Overall, the side effects observed after the first dose of BNT162b2 in volunteers aged 65 to 85 years were comparable to the side effects in the placebo group. After the second vaccination of 30 µg with BNT162b2, only 17 percent of the subjects between 18 and 55 years of age and 8 percent of the subjects between 65 and 85 years of age developed fever (≥ 38 to 38.9 ° C). For comparison: 75 percent of the subjects in the age group between 18 and 55 years and 33 percent in the age group between 65 and 85 years developed a fever after they were treated with a second dose of 30 μg BNT162b1. More severe side effects such as tiredness, headache, chills, and muscle or joint pain were observed in a small number of younger volunteers treated with BNT162b2. However, these occurred only briefly and were treatable. There were no serious side effects in elderly subjects treated with BNT162b2. In addition, no Grade 4 systemic reactions were observed in BNT162 subjects.
There was applause on the stock exchange: Biontech’s shares were traded vigorously on the Tradegate trading platform. The shares listed for the first time on the Nasdaq rose there by around 8 percent. The Biontech price has quadrupled since its initial listing on the US stock exchange at an issue price of $ 15 last October.
In the event of success, the two development partners continue to plan to apply for approval for the active ingredient in October at the earliest. If the vaccination gets the green light from the authorities, up to 100 million doses are to be delivered worldwide by the end of this year. The two companies plan to have around 1.3 billion vaccine doses by the end of 2021.
BNT162b2 codes for an optimized SARS-CoV-2 spike glycoprotein (S) in its full length. Whether the vaccine candidate actually protects against corona infection must be shown in phase II / III. This approval-relevant study with the BNT162b has been running since July. Up to 30,000 people should take part. So far, 11,000 participants have been included in the program, it said. These include people from areas in which the virus is spreading widely: Argentina and Brazil are also included in addition to the USA. Further recruiting of test subjects is planned in Germany, Turkey and South Africa.
Pfizer-BioNTech 2nd Covid Vaccine Shows Less Side Effects - /10
Pfizer and Biontech are making progress in their search for a vaccine against the Sars Cov-2 virus