Pfizer makes bid to have BA.5-specific COVID-19 jab approved by the FDA

New COVID-19 vaccine shots, tailored to the BA.5 Omicron variant could soon be around the corner, as Pfizer announced that it has submitted a bid to have its new shot approved by the FDA.

The New York City-based firm, which has partnered with the German company BioNTech is the development and manufacturing of the shots, announced that it made its submission to the Food and Drug Administration (FDA) on Monday.

It is a long-awaited move, with experts having discussed the prospect of a new, Omicron-specific, vaccine since the end of 2021 – when it first became clear the virus had evolved an ability to evade protection against infection provided by the shots.

Some have opposed the rolling out of these new shots, though. While the existing vaccines – which were tailored to the original Wuhan virus strain – do not provide significant protection against infection from the virus, their ability to prevent severe illness or death is still strong.

The move comes as Daily U.S. Covid cases remain stagnant. The nation is averaging 106,098 daily infections – staying in the range it has remained in since May. America is also averaging 577 deaths from the virus each day.

‘The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,’ Albert Bourla, CEO of Pfizer, said in a statement.

He also said that the company has the ability to begin distribution of the shots immediately after FDA approval. 

Regulators have previously said they aim to get the shots out before the fall. In previous years, the cold-weather season have come alongside jumps in cases.

Health officials are hoping to dodge that this year, hoping the updated boosters will prevent wide Covid spread.

‘Given the ongoing evolution of SARS-CoV-2 and its variants, it’s of great importance that vaccines can be rapidly adapted to the major circulating Omicron lineages,’ Ugur Sahin, CEO of BioNTech, said in a statement.

‘In less than three months after the FDA provided its guidance for adapted vaccines in the U.S., we are ready to ship the first doses of our Omicron BA.4/BA.5-adapted bivalent vaccine, pending regulatory authorization, to provide people in the U.S. 

‘With the possibility to get a booster adapted to the currently most dominant strain of the virus.’ 

Whether Americans will actually go out to receive the shots is a question in itself, though.

This would be the fourth shot available to Americans under the age of 50, and the fifth for those older.

Rollout of previous boosters have largely been a dud, with Americans not getting the shots in the numbers officials had hoped.

Some leading experts have opposed the approval of these shots as well, saying that they will not actually do much to boost immunity either.

Dr Paul Offit, a leading advisor to the FDA on matters related to vaccines and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, wrote in a STAT News op-ed that the additional antibodies provided by the shot will not do much to prevent infection.

Offit notes that in data submitted by both Pfizer and their major competitor Moderna, the additional Omicron booster raised the antibody levels twofold, though he doubts they’ll provide much effectiveness overall.

‘That kind of twofold difference is, for example, similar to the modestly greater peak in neutralizing antibodies triggered by the first two doses of the Moderna vaccine compared with the Pfizer vaccine,’ he explained, noting that the protections provided were similar.

‘Those two vaccines provided almost identical protection against mild and severe Covid-19, although the benefits of the Pfizer vaccine waned a bit quicker over time.’

Data submitted by the companies focused on antibody levels found in blood samples pulled from trial participants.

Antibodies provide diminishing returns, though, and doubling antibody levels does not exactly provide double the protection.

Offit says data on actual protection from infection, hospitalization and death needs to be collected first to determine how valuable these newly formulated shots are.

‘Moderna and Pfizer executives have claimed that the Omicron vaccines will be protective for longer. That may be true, but how long is longer? A few weeks? A month or two?’ he asks.

The FDA is eager to get these shots out, already setting targets for rollout before they’ve even been authorized.

Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, the agency’s top regulatory body for vaccines, said last month the aim was to make Omicron-specific jabs available by September.