Settlers set to open soon for Covid-19 vaccination

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But still only healthcare workers for now

Public and private healthcare workers within the Department of Health’s Makana Subdistrict will soon be able to receive Covid-19 vaccinations at Settlers Hospital, says the Health Department’s Makana Subdistrict head Mohamed Docrat. Meanwhile, international research published recently in a respected scientific journal reports positively on the efficacy, safety and practicality of the Ad26.COV 2.S (J&J) vaccine.

This comes as registration has opened for vaccinations for over-60s scheduled to begin on 17 May and the South African Health Products Regulatory Authority has recommended lifting the suspension of the J&J Sisonke Vaccination Programme.

Close to 70% of health care workers (HCWs) in the Makana Subdistrict administrative area of the Department of Health have already been vaccinated. The Subdistrict incorporates Makana and Ndlambe municipalities.

Public and private healthcare workers in the Eastern Cape have been getting vaccinated through the Sisonke research programme based at Dora Nginza , Greenacres and Livingstone hospitals in Port Elizabeth, Docrat said.

Soon, for local HCWs, it will continue in Makhanda.

“We will be replicating the system here at Settlers Hospital,” Docrat said.

The remaining 30 percent of healthcare professionals and auxiliary staff includes support staff at health institutions – HR, cleaners, porters etc, as well as pharmacists and physiotherapists. Traditional health
practitioners were being considered for inclusion at the time. Undertakers and forensic services are among those in Phase 1 of the rollout.

South Africa launched phase 1 of the vaccination rollout programme using the Johnson & Johnson vaccine on 17 February after 800 000 doses of the Johnson & Johnson vaccine arrived in the country.

While an application for licensing of the J&J vaccine was underway, the Sisonke (“Together”) programme allowed the government to make the vaccine immediately available to healthcare workers using a research study.

Likely to boost confidence in the current programme is the article by an international research group published yesterday 21 April 2021 in the New England Journal of Medicine. It concludes that a  single dose of Ad26.COV2.S protected against symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection and was effective against severe–critical disease, including hospitalisation and death.

South Africa’s Health Ministry has said that protecting healthcare workers before the third wave of Covid-19 begins is a priority and that the third wave is predicted to begin in South Africa this winter.

Docrat said the system to vaccinate healthcare workers at Settlers Hospital will replicate the programme already started under the Sisonke Protocol. The difference would be in the handling steps.

The vaccinated healthcare workers are monitored closely for side effects.

“There have been very few side-effects – especially in the Eastern Cape,” Docrat said. “And none have been severe.”

Among the healthcare workers in the Makana Subdistrict, close to 70% had already been vaccinated, Docrat said.

“They have responded very positively and very few have refused the vaccine.”

Rollout phases and research phases

The vaccine rollout is currently in its first phase in South Africa. Healthcare workers are targeted in this phase being carried out under the Sisonke Protocol.

The research to complete the testing of the Ad26.COV 2.S (‘Johnson & Johnson’) vaccine is in Phase 3 of the Clinical Development stage. The research was done on 44 000 participants on four continents, including
7000 in South Africa. It was conducted by a group of scientists co-operating internationally in a research group called ENSEMBLE. Several South African scientists are part of the research team. The research article, with its findings, is published on 21 April 2021 in the New England Journal of Medicine.

There are 6 stages in a vaccine’s development (explanation summarised and paraphrased from the website of the Centre for Disease Control): Exploratory; Preclinical; Clinical development; Regulatory review and approval; Manufacturing; Quality control.

The J&J vaccine is in the Clinical Development stage.

Clinical development of any new vaccine has three phases:
Phase I – small groups of people receive the trial vaccine.
Phase 2 – groups of people receive the vaccine who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended.
Phase 3 – the vaccine is given to thousands of people and tested for efficacy and safety.
Phase 4 – post-development, formal, ongoing studies after the vaccine is approved and licensed.

Phase 3 of the Clinical development stage for the J&J vaccine has been completed. It this crucial stage that the article in the New England Journal of Medicine published recently reports on. The article makes important conclusions on the efficacy, safety and practicality of the Ad26.COV2.S (J&J) vaccine.

It concludes: “In this trial, we found that a single dose of Ad26.COV2.S protected against symptomatic Covid-19 and was particularly efficacious against severe – critical disease (including hospitalization and death), including in countries where variants that are considered to be relatively resistant to antibody neutralization predominate.

“Safety appeared to be similar to that seen in previous phase 3 trials of Covid-19 vaccines. The single-dose schedule and favorable storage conditions of this vaccine provide major advantages in its deployment and effect worldwide.”

Suspension on J&J vaccine lifted

On 13 April South Africa along with the US and the European Union temporarily stopped the rollout of the J&J Covid-19 vaccination.

Health Minister Zweli Mkhize announced on 13 April that South Africa would pause the rollout of the J&J vaccine in light of the decision taken by the US Food and Drug Administration to advise its temporary suspension there.

This was due to reports that six women among the 6.6 million US citizens inoculated developed unusual blood clots 6-13 days after vaccination. The women were between the ages of 18 and 48.

Mkhize emphasised that In South Africa, after innoculating 289 787 health care workers under the Sisonke Protocol, there had been no reports of clots that formed after vaccination.

Based on South African scientists’ advice, the Health Ministry decided to voluntarily suspend South Africa’s rollout “until the causal relationship between the development of clots and the Johnson and Johnson vaccine is sufficiently interrogated”.

A statement issued by the Government Communication and Information Services (GCIS) said in its meeting on 21 April, Cabinet welcomed the recommendation by the South African Health Products Regulatory Authority to lift the suspension of the J&J Sisonke Vaccination Programme.

“Our scientists will continue to monitor all South Africans as and when they are vaccinated. By mid-April 2021, more than 292 623 HCWs had been vaccinated under the Sisonke Vaccination Programme,” said Cabinet spokesperson Phumla Williams.

GMDirect understands recommendations are likely to include that pre-vaccination consent documents reflect the clotting risks as rare possible side effects. Because the current phase of vaccination falls under the Sisonke research protocol, it’s likely that approval by the National Health Research Ethics Council would be required to make such a change to the consent document.

Further progress in rollout

The Cabinet welcomed progress in the signing of the contract with J&J on the procurement of J&J vaccines for the full roll-out programme, and commended Mkhize and Minister of Trade, Industry and Competition, Ebrahim Patel, for resolving procurement issues.

The successful negotiation of an additional 10 million doses of the Pfizer vaccine was applauded. This brought the total doses of the Pfizer vaccine to 30 million, Willliams said.

“This means South Africa will be able to vaccinate 15 million people with the Pfizer vaccine instead of just 10 million,” the GCIS statement said.

Getting the Covid-19 vaccine in Makhanda

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