The pharmaceutical giants have submitted early stage clinical trial data to the FDA to seek authorisation for Covid-19 booster shots.
With the constant mutation of the coronavirus into different, deadlier strains, pharmaceutical giants Pfizer and BioNTech have submitted early stage clinical trial data to the Food and Drug Administration (FDA) as part of a US application seeking approval for a Covid-19 booster vaccine for those 16 and older.
In a first phase trial, a booster dose of the Covid-19 jab created “significantly higher neutralising antibodies” against the original coronavirus strain, as well as the Beta and Delta variants.
Participants in the trial received a third shot of the vaccine around eight to nine months after receiving their second shot.
“This initial data indicate that we may preserve and even exceed the high levels of protection against the wild-type virus and relevant variants using a third dose of our vaccine,” said Dr Ugur Sahin, CEO and co-founder of BioNTech.
Pfizer and BioNTech said that late-stage trial results assessing the third dose are to be expected soon before being submitted to the FDA and other global regulatory bodies.
“The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule,” Pfizer CEO Albert Bourla said in a statement. “We are pleased to submit these data to the FDA as we continue working together to address the evolving challenges of this pandemic.”
The latest development comes after federal health officials approved of the administration of Covid-19 booster shots from Pfizer and Moderna vaccines to Americans with weakened immune systems.
The patients included those with cancer, HIV patients and people who have had organ transplants.
US data suggests that two doses of a Covid-19 vaccine are not enough for immune-compromised individuals to produce a satisfactory immune response.
The latest data from Pfizer analyses the booster’s safety and immune response in people with healthy immune systems.
White House chief medical advisor, Dr. Anthony Fauci has confirmed that everyone will “likely” need a booster shot at some point in the future, a sentiment that has been mirrored by Covid vaccine makers, affirming the potential of extra doses every year.
Pfizer cited data out of Israel after officials said that the two-dose vaccine was only 39% effective against the disease as the highly contagious delta variant ravages the world.
Israel, which has been heavily criticised for refusing to vaccinate the occupied Palestinian population, previously announced it would give booster doses to elderly Israeli citizens.
Meanwhile, the World Health Organization (WHO) has called on wealthy nations to postpone the administration of Covid-19 booster vaccines for at least two months.
WHO said that the halt would give the world an opportunity to vaccinate 10% of every country’s population by the end of September.