Pfizer-BioNTec approved for emergency use in SA: here is what you need to know about the vaccine

As SA prepares for the second phase of the Covid-19 vaccine rollout, the SA Health Products Regulatory Authority (Sahpra) has approved a “section 21” emergency use application for the Covid-19 vaccine developed by Pfizer-BioNTec.

According to Sahpra, this means that the sought-after vaccine has been approved for distribution but the approval is subject to monitoring the vaccine’s efficacy and safety.

“This approval is subject to conducting a post-section 21 authorisation efficacy and safety surveillance of comirnaty vaccine in SA (including efficacy against the SARS-CoV2 B. 1.351 lineage), said the authority.

Here is what you need to know.

Vaccine process

To date, the total number of vaccines administered is 157,286 out of the 500,000 health workers that were targeted when SA kick-started the vaccination campaign with Johnson & Johnson's one-dose vaccine last month.

According to health deputy minister Joe Phaahla, SA secured 20 million vaccines from Pfizer and additional supplies through the Covax facility and the African Union.

However, the vaccines were not due to arrive as soon as the government had hoped and this could likely see SA missing its mark to vaccine 1.5 million people by the end of the month.

Pfizer-BioNTech is an 'unapproved' vaccine

According to the food and drug administration (FDA), the Pfizer-BioNTech vaccine is an unapproved vaccine that may prevent Covid-19. There is no FDA-approved vaccine to prevent Covid-19.

In February, the FDA authorised the emergency use of the Pfizer-BioNTech vaccine to prevent the virus in people 16 years and older under an emergency use authorisation (EUA).

The vaccine is two doses given three weeks apart. One dose of the vaccine 54.2% to 84.5% effective in preventing the virus after four weeks.

“If you receive one dose of the Pfizer-BioNTech Covid-19 vaccine, you should receive a second dose of this same vaccine three weeks later to complete the vaccination series,” said the FDA.

Vaccine side effects

Some of the side effects that have been reported with the Pfizer-BioNTech vaccine include tiredness, headache, muscle pain, chills,  joint pain, feeling unwell, and non-severe allergic reactions such as rash, itching, hives, or swelling of the face.

“There is a remote chance that the vaccine could cause a severe allergic reaction. This would usually occur within a few minutes to one hour after getting a dose,” said FDA.

“For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Serious and unexpected side effects may occur. The vaccine is still being studied in clinical trials.”

Not recommended for pregnant women

The vaccine is not recommended for pregnant or breastfeeding women, according to the World Organisation Health (WHO). 

“Pregnant women are at higher risk of severe Covid-19 than non-pregnant women, however, due to insufficient data, we do not recommend the vaccination of pregnant women at this time,” said WHO.

“In case a pregnant woman has an unavoidable risk high of exposure, vaccination may be considered in discussion with their health-care provider.

“If a breastfeeding woman is part of a group (health workers) recommended for vaccination, vaccination can be offered. WHO does not recommend discontinuing breastfeeding after vaccination.”