New York: Pfizer, and its partner BioNTech, have started clinical trials for a new COVID-19 vaccine that is specifically targeted at the Omicron variant, which they say could be available as early as late March. The New York City based pharmaceutical company announced that it is recruiting 1,420 participants for a three cohort trial that will determine the safety and effectiveness of the company’s shot. It has launched the trial despite CDC data showing that the fast-spreading variant already appears to have peaked in the US, meaning it could have largely disappeared by the time a shot is ready.
Albert Bourla, CEO of the company, indicated earlier this month that his company expects to submit data for authorization to the Food and Drug Administration (FDA) in March. Some of the participants are the same as those who took part in trials for the company’s booster shot and all are between the ages of 18 to 55 – implying the jab will only be available to adults at first.
“While current research and real-world data show that boosters continue to provide a high level of protection against severe disease and hospitalization with Omicron, we recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future,” Kathrin Jansen, Senior Vice President and Head of Vaccine Research & Development at Pfizer said in an official statement.
Pfizer said that its clinical study will evaluate 1,420 participants across the three cohorts as following:
- Cohort one: Received two doses of the current Pfizer-BioNTech COVID-19 vaccine 90-180 days prior to enrollment; in the study, participants will receive one or two doses of the Omicron-based vaccine.
- Cohort two: Received three doses of the current Pfizer-BioNTech COVID-19 vaccine 90-180 days prior to enrollment; in the study, participants will receive one dose of the current Pfizer-BioNTech COVID-19 vaccine or the Omicron-based vaccine.
- Cohort three: Vaccine-naïve participants will receive three doses of the Omicron-based vaccine.
Citing clinical and real world data, Pfizer said that people who are vaccinated, particularly those that have received a booster, maintain a high level of protection against Omicron, particularly against severe disease and hospitalization.
The trial will test three different regimens for the new vaccine. A one shot jab will be given to 615 participants, two shots to 600 participants and a three shot version for 200.
Each of the participants received the Pfizer vaccine for their additional vaccine regimen. Those in the one shot group are not boosted, while those in the two and three shot groups had previously received the Pfizer booster shot.
The Pfizer-BioNTech vaccine was the first Covid shot to be authorized in the West, in December 2020.
Because it is based on messenger RNA technology, it is relatively easy to update to reflect the genetic code of new variants.
Several countries have begun to emerge from their latest waves driven by Omicron, the most transmissible strain to date, even though global new cases are still rising.
The coronavirus has killed some 5.6 million people since the outbreak emerged in China in December 2019.
from World – India.com | Top Latest News from India, USA and Top national Breaking News stories https://ift.tt/3KDrkjf
