Pfizer to remain in demand for use in children as other manufacturers take their time

The Pfizer-BioNTech Covid-19 vaccine could remain the only one approved for use in children for some time, as some vaccine manufacturers – like Oxford/AstraZeneca – are yet to submit data on clinical trials to the World Health Organization (WHO).
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By Orville Williams

[email protected]

Countries like Antigua and Barbuda that have begun utilising the Pfizer-BioNTech Covid-19 vaccine to inoculate children above 12, will likely have to continue depending on that particular shot for the foreseeable future.

This, as the Pan-American Health Organization (PAHO) says it may be some time before other vaccines receive similar approval from the world’s leading public health agency.

The World Health Organisation (WHO) granted the Pfizer-BioNTech vaccine emergency use listing (EUL) back in December last year, and “thoroughly assessed its quality, safety, and efficacy” before recommending its use for persons above the age of 16.

According to the WHO, “A phase three trial in children aged 12-15 years showed high efficacy and good safety in this age group, leading to an extension of the previous age indication from 16 years onwards down to age 12 onwards.”

Since then, the Pfizer-BioNTech has remained the only vaccine recommended for use in persons younger than 18 years, despite concerns about its availability compared to other vaccines.

These other vaccines – including the most accessible and likely, most widely used Oxford/AstraZeneca – are expected to execute clinical trials with age groups below 18 years, in order to satisfy the WHO and receive approval for use. However, they are seemingly not moving as fast as Pfizer did.

According to Dr Jarbas Barbosa, Assistant Director of PAHO, while some vaccine manufacturers have shared the necessary data and formally requested consideration for approval, others have yet to even take that step.

“The [manufacturers] that have presented the request to receive authorisation from WHO to use their vaccines in children are Sinovac, Sinopharm and Moderna; they are still under review,” he said.

Of that list, only the Sinopharm vaccine is currently available in Antigua and Barbuda, though the government has voiced its intention to purchase doses of other brands for use in the public vaccination programme when they become available.

In the case of the Oxford/AstraZeneca vaccine, Dr Barbosa disclosed that its manufacturers are yet to even submit an official request for authorisation for use in children, adding that, “I cannot anticipate when AstraZeneca will present [that request]”.

He acknowledged the importance of the AstraZeneca vaccine to countries across the world, particularly poorer territories, but stressed that there is nothing the authorities can do unless the manufacturers provide the necessary data.

“AstraZeneca is a very important producer of vaccines…it’s a very affordable vaccine, but this [push for authorisation] needs to come from the producer.

“They need to complete [clinical trials] before presenting their request to the WHO [and they’re] probably still performing these clinical trials, because they haven’t presented the request yet.”

It’s important to note that the clinical trials of the Oxford/AstraZeneca Covid-19 vaccine in children were suspended earlier in April, after the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched an investigation into a possible link between the vaccine and rare blood clots in adults.

The paediatric trials had started in February with over 200 children between ages six and 17, but there has been no confirmation whether they have since restarted.

With the AstraZeneca vaccine likely to be the most accessible to countries like Antigua and Barbuda for the immediate future, the hope is that the manufacturers will complete the trials sooner rather than later, or that the other vaccines – once they receive approval for use in children – will become more accessible.

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