The Covid-19 vaccines in trial phase has yet to be proven completely safe for pregnant women, HIV positive people and TB patients – Independent Online

A woman holds a small bottle labelled Coronavirus COVID-19 Vaccine. REUTERS

By Nathan Adams Dec 1, 2020

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IT IS yet to be determined if any of the Covid-19 vaccines that are being trialled around the world and in development here in South Africa will in any way negatively impact pregnant women, those on TB medication and people with HIV/Aids who are on antiretroviral therapy.

For now, the groups who are part of the trials are small, but the results are encouraging; that within the next few months, a Covid-19 vaccine will be on the market and available to the public.

There are various Covid-19 vaccine trials taking place around the world and two kinds of studies are being conducted, either a protein based vaccine or a gene based vaccine.

In South Africa, the National Institute for Communicable Diseases (NICD) stated in March this year that: There (is) no data currently available on Covid-19 disease in people living with HIV and/or TB. They added: This might be important since South Africa has a large burden of HIV and TB disease and early reports indicate that people with other comorbid conditions (eg cardiovascular disease) or secondary infections have more severe Covid-19 disease and worse outcomes.

There are reportedly 7.7 million people living with HIV in SA, more than 5 million are on ARTs. And in 2018 it was estimated there were over 301 000 cases of TB in the country and that about 60% of the TB patients are people living with HIV.

Professor Linda-Gail Bekker is the deputy director of the Desmond Tutu HIV Centre at the Institute of Infectious Disease and Molecular Medicine. She said its still to early to make a determination on whether a Covid-19 vaccine will be safe for use for these vulnerable groups already on chronic medication.

We always like to check safety in a variety of patients in terms of age, comorbidity and status, for example women who are pregnant or breastfeeding. She added: Unfortunately we are not yet likely to have had many of these other population groups outside of general adults from a general adult age group.

It's likely that this additional data will be monitored in the setting of a phase 4 or post marketing setting.

Professor Bekker cautioned that time will tell: I think we will need to see what regulators do in terms of how general they allow the licensure label to go, ie which populations are included and which will require more data on.

Professor Eric Decloedt, is the associate professor: division of clinical pharmacology in the department of medicine of the Faculty of Medicine and Health Sciences at Stellenbosch University. He said initial data showed the Covid-19 vaccine could be universally used.

The vaccine efficacy and safety is unlikely to be influenced by ARVs, TB medicines or birth control. But safety and efficacy should be evaluated in all populations including children and pregnant women, said Decloedt.

Meanwhile the team at pharmaceutical giant Pfizer are encouraged by the results of their vaccine in the trial stage.

Pfizer SA spokesperson Rhulani Nhlaniki said: We recognize that developing a potential vaccine against Covid-19 for broad use is critically important to help combat the pandemic, including for potential use in pregnant women. We are working on a potential pathway to include a maternal indication in our programme.

There is little data as to the potential side effects of the Covid-19 vaccines currently being developed.

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The Covid-19 vaccines in trial phase has yet to be proven completely safe for pregnant women, HIV positive people and TB patients - Independent Online