Pfizer’s pneumococcal vaccine gets South African approval

Image copyright AFP Image caption The vaccine booster uses live BV virus

South Africa’s National Health Agency has approved a vaccine booster for Pfizer’s blockbuster pneumococcal conjugate vaccine (PCV).

Two years ago, the agency granted conditional approval for a reduction in vaccination dose for the vaccine.

Now Pfizer’s booster – called MVA85A – has been licensed under the same conditions.

PCV is one of the world’s most commonly used vaccines.

The introduction of the vaccine is expected to double the number of young children receiving routine vaccination in South Africa.

Pfizer submitted a request for the secondary indication on 19 July and it received provisional approval by the South African National Health Agency on 3 September.

“This new indication is an extension of the existing use of PCV in paediatric populations,” said Dr Axel de Hoop, managing director of Pfizer South Africa.

“It represents a significant opportunity for Pfizer to provide immunisation to the majority of children aged 9-12 months and reduces the vaccination dose for the booster vaccination in infants and young children.”

The secondary indication will be available with PCV 600/1200, so that vaccinators can make an informed decision about whether to administer the booster vaccine.

Rationale

Other pre-programmed doses of PCV 600/1200 will continue to be administered by health practitioners when appropriate.

“The fact that MVA85A is designed to become more effective over time makes it an important product for epidemics such as meningitis,” said Dr De Hoop.

The South African National Health Agency will monitor the safety and effectiveness of the new shot in clinical trials and early results look encouraging.

In the previous study, Dr de Hoop said that in the 1-2 months following clinical exposure to MVA85A, the dose injected into the recipient child was about 50% higher than the original dose.

“Within this, there was a significant level of dosing effect that we have observed in the booster populations, raising the questions of whether in some paediatric patients, MVA85A may become effective at a lesser dose,” he said.

“That is why our clinical trials programme is expected to reveal this answer.”

The agency issued a clinical safety alert on 11 October after it was notified that a hospital in the North West province had begun administering the booster at only half dose.

Meningitis is a bacterial infection of the lining surrounding the brain and spinal cord.

Thousands of children worldwide die every year of the disease and it can be especially devastating in poorer countries.

In addition to fatalities, meningitis can lead to permanent brain damage and even death.

South Africa currently has high rates of meningitis but the number of cases has recently fallen as vaccination campaigns have increased.

Pfizer has been developing MVA85A for 10 years but trials have not been successful because the vaccine is directed against PCV 9, which is of uncertain effectiveness.

A vaccine against BCG – which protects against a range of pneumococcal infections and is a priority vaccine for young children worldwide – also remains years away from commercialisation.

Pfizer South Africa intends to launch an extensive promotional and marketing campaign in South Africa once MVA85A is manufactured and ready for sale.

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