Pfizer & BioNTech Launch Trials of COVID-19 Vaccine Specifically Designed for Omicron

At the end of 2021, Omicron once again had the world in anxiety when it was announced as a new and more infectious variant of COVID-19.

Fortunately, it was later found to be less deadly. This time, Pfizer and BioNTech bring even better news.

Trial for Omicron Vaccine

On 25 January, Pfizer and BioNTech said they had started a clinical trial to test a new version of their vaccine specifically designed to target the COVID-19 Omicron variant.

The Omicron variant is known to have escaped some of the protection provided by the original two-dose vaccine procedure.

The companies are set to test the immune response generated from the Omicron-based vaccine in volunteers from the United States.

The test will be carried out as a three-shot regimen in unvaccinated individuals as well as a booster shot for individuals who have already received two doses of their original vaccine.

Additionally, they are also testing a fourth dose of the existing vaccine against a fourth dose of the Omicron-based vaccine in people who received a third dose of the Pfizer-BioNTech vaccine three to six months earlier.

Pfizer and BioNTech plan to study the safety and tolerability of the shots in over 1,400 people who are taking part in the trial.

Need For Additional Protection

Pfizer’s head of vaccine research and development, Kathrin Jansen, said in a statement that the company recognises the need to be prepared in the event that the vaccine’s protection “wanes over time” and to “potentially help address Omicron and new variants in the future”.

BioNTech said that depending on the amount of clinical trial data required by regulators, it is unlikely for a current plan to launch an Omicron-targeting vaccine by the end of March.

Pfizer has also said that two doses of the original vaccine may be insufficient to protect against infection from Omicron. Current protection against hospitalisations and deaths may be deteriorating.

However, the US Centres for Disease Control and Prevention says a third dose of an mRNA vaccine like the Pfizer-BioNTech vaccine has provided 90 per cent protection against hospitalisation due to COVID-19.

While some countries have started offering additional booster doses, a recent study from Israel showed that a fourth dose of an mRNA vaccine boosted antibodies but was not high enough to prevent Omicron infection.

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Data Wanted Before Approval

The European Medicines Agency (EMA) said that international regulators want data from clinical studies similar to the one by Pfizer and BioNTech before approval of a new vaccine.

EMA said the studies should show that the new vaccines elicit more neutralising antibodies in the blood than current vaccines and have protection against new variants.

BioNTech refused to comment on what type of data it was asked to file with regulators.

It said that an analysis of antibodies produced by its Omicron-targeted booster vaccine should provide answers as to whether shots will be needed that address more than one variant at a time. It hopes to show that the antibodies can target a spectrum of variants.

With the ever-evolving pandemic situation, we can never be too sure of when a new variant might appear. However, with advanced technology, we can be hopeful of improved research and new vaccines that might bring us closer to our normal lives again.

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