The Expanded Access

At present the authorised ones include a two-dose regimen of the Pfizer-BioNTech and Moderna vaccines, or a single dose of the Johnson & Johnson shot. Hence this result in exploring a programme (expanded access or compassionate use) that allows sick people to get unapproved drugs by the CDC until FDA grants the permission.

This program generally allows the patients with a serious disease or condition to get access to investigational new drug/product that is not FDA-approved. E.g., Coronavirus vaccines.

“FDA, CDC, and NIH (National Institutes of Health) are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary,” says the report statement.

The experts believe that the booster dose in immunocompromised people may enhance the antibody responses against the disease. The third dose of the Pfizer-BioNTech coronavirus vaccine to severely immunocompromised adults has been now rolled out even by Israel.

France is also offering booster shots to immunocompromised individuals. Meanwhile Pfizer COVID-19 vaccine dose preparation has been undertaken by a staff member at the Melbourne Showgrounds in Australia.

Merits Of Booster COVID-19 Shot

• The third COVID-19 vaccine dose of – either Pfizer’s, Moderna’s or Johnson & Johnson’s showed boosted antibody levels in certain immunocompromised organ transplant recipients as per Annals of Internal Medicine.
• In a study of 30 booster dose vaccinated patients, 12 patients (6 had no antibodies and 6 had low levels prior) had developed high levels of antibodies, 2 had low levels and 16 still didn’t develop any antibodies.
• Other study in the New England Journal of Medicine showed that 67 out of 99 organ transplant recipients vaccinated with Pfizer’s jab had developed antibodies after a third dose.
• Lancet reported detectable antibodies after two doses of Pfizer’s COVID-19 vaccine in more than 75% of blood, or hematopoietic, stem cell transplant recipients.
• Among 12 dialysis patients with no initial antibody levels after two vaccine doses, an extra shot mounted the antibody response in almost half of them as per a preliminary study posted at medRxiv.org.
• Almost 42%, that is, 5 out of 12 antibody-negative patients had good response to third vaccine as per Nephrology Dialysis Transplantation.

As the data on third dose continues to prove its efficacy, it is important for these immunocompromised patients to continue COVID-19 – necessary precautions like wearing masks, staying six feet away from others and avoiding crowds.

Source: Medindia