US FDA Set To Approve Covid-19 Booster Shot For Immunocompromised

By Alifah Zainuddin |

The emergency use authorisation does not include fully vaccinated healthy people as both the Pfizer-BioNTech and the Moderna vaccines have shown to be highly effective at preventing hospitalisation and death in this group.

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KUALA LUMPUR, August 12 — The United States’ Food and Drug Administration (FDA) is expected to allow people with compromised immune systems to get a third dose of either the Pfizer-BioNTech or Moderna Covid-19 vaccines, according to NBC News.

An advisory panel to the US Centers for Disease Control and Prevention (CDC) met last month and urged action on extra doses for immunocompromised adults as emerging data shows that many of these patients are still vulnerable to Covid-19, despite being fully vaccinated.

The CDC estimates that 2.7 per cent of adults in the US are immunocompromised. Immunocompromised patients include organ transplant recipients, people undergoing cancer treatment and people with HIV, among others. However, it remains unclear if the expected FDA action would cover all groups, the report said.

The emergency use authorisation does not include fully vaccinated healthy people as both the Pfizer and the Moderna vaccines have shown to be highly effective at preventing hospitalisation and death in this group.

Moderna’s Covid-19 shot was about 93 per cent effective through six months after the second dose, showing hardly any change from the 94 per cent efficacy reported in its original clinical trial.

However, the company said a booster dose might be necessary prior to the winter season as antibody levels are likely to wane.

That compares favourably with recent data from Pfizer in which its vaccine’s efficacy is found to wane around six per cent every two months, declining to around 84 per cent six months after the second shot.

Both the Moderna and Pfizer vaccines are based on mRNA technology.

The CDC advisory group will meet Friday when it is expected to vote on whether to recommend a third shot for immunocompromised people officially. The panel’s signoff is needed before doctors can start prescribing extra doses.

Such a vote is only done after the FDA takes regulatory action, such as the expected amendment to the emergency use authorisation.

Last week, the Mississippi Department of Health recommended immunocompromised people receive an additional vaccine dose, despite no official word of approval from federal health officials.

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