‘It was like a cold’: infections after J&J jabs proving to be ‘mild to moderate’

Healthcare workers in SA are getting “breakthrough infections” of Covid-19 during the rising third wave in SA, but more than 90% of these cases are mild to moderate, said the scientists in charge of the Sisonke implementation study which delivered the life-saving J&J shots to them from February to May.

Sisonke co-principal investigators profs Glenda Gray and Linda-Gail Bekker said: “Of the cases we have so far validated we have found that 93% are asymptomatic or mild — not requiring hospital admission.”

Dr Erica Lazarus, site principal investigator of the Chris Hani Baragwanath Sisonke vaccination site, hears of breakthrough infections every day but most of them are mild, like her own infection, she said.

Lazarus, who got vaccinated on February 19, developed symptoms of Covid on May 16 and on May 18 got a positive test result.

“It was the day before my birthday,” she said. “I had a very minor sore throat, a postnasal drip and coughed once or twice. I occasionally got a fever, and I lost my sense of smell and taste.

“It was like a cold, not even flu. At that stage the Delta variant had not spread in SA,” said Lazarus, who had to be in isolation even though she felt well enough to work.

After developing Covid symptoms on Friday, Wits senior clinical researcher Dr Nomathemba Chandiwana got a positive test result on Sunday.

“After a busy week of seeing Covid-19 positive patients, I started feeling unwell on Thursday night,” said Chandiwana, who was vaccinated in February with the first batch of healthcare workers.

To date, her symptoms feel mostly “like a bad cold”, but some doctors have experienced fevers and other debilitating symptoms.

I had a very minor sore throat, a postnasal drip and coughed once or twice. I occasionally got a fever, and I lost my sense of smell and taste.

—  Dr Erica Lazarus, site principal investigator of the Chris Hani Baragwanath Sisonke vaccination site

In reply to queries, Gray and Bekker said: “We have had breakthrough infections 28 days post vaccination and are carefully tracking these and making contact to understand severity and outcome.

“We are encouraged by the results (93% symptomatic or mild disease) and look forward to analysing the effectiveness data soon.”

The efficacy of Covid-19 vaccines is measured by “how they modify Covid-19 disease and whether they prevent Covid-19 death”, not the prevention of SARs-COV-2 infections.

“The vaccines hopefully reduce disease in all but especially the most vulnerable (which Covax estimates is about 10 to 20% of the population).

If 70% to 80% of the population is vaccinated “an extra bonus is that they would then provide herd protection”, they said.

The J&J Covid-19 vaccine is being used in SA’s national rollout alongside the Pfizer vaccine.

“The Ensemble phase 3 study (on the J&J vaccine), reassured us that while overall vaccine efficacy worldwide for moderate Covid-19 was 66%, it was 72% in USA and 64% in SA. The reason for the discrepancy here is probably due to the Beta variant, which we know was circulating here at the time.”

Importantly, in all three regions involved in the clinical trial, the impact on severe disease and death was consistent at 83%.

“We don’t yet know what the impact was on prevention of infection from the phase 3 trial,” they said.  

“We hope infection may be prevented altogether, yet we do not know how often this occurs.”

The Sisonke phase 3B study was more than 15 times bigger than the Ensemble trial.

To evaluate vaccine effectiveness, Sisonke is collecting all reports of breakthrough infections 28 days after vaccination.

The scientists said: “To do this, we are relying on the vaccinated healthcare workers or their employers or other stakeholders to report their infections to the Sisonke safety desk.

We follow up every reported death and scrutinise the death register to ensure we capture every death to assess possible Covid-related deaths post vaccination.

—  Sisonke co-principal investigators profs Glenda Gray and Linda-Gail Bekker

“We also follow up with the national laboratory services and the database that records all Covid-related hospital admissions.

“By triangulating these three data sources we can get a good handle on all the infections occurring post vaccination on Sisonke.”

The Sisonke Study evaluates the history of each person with a breakthrough infection, determines the severity of their symptoms (if any), gets diagnostic swabs and does further evaluations for “viral genomic assessment”, which relates to the variant driving the infection.

“We also follow up every reported death and scrutinise the death register to ensure we capture every death to assess possible Covid-related deaths post vaccination,” said Gray and Bekker.

People inoculated with the J&J vaccine had “robust antibody responses” against the virus for seven to eight months, according to earlier studies.

“Similarly, the Ensemble phase 3 data suppors increasing vaccine efficacy over time well beyond the 28 days,” said Gray and Bekker.

“The Sisonke 3B interim effectiveness analysis will be conducted after we have closed the data base at the end of July, when we have had sufficient wave three exposure to give an adequate assessment,” they said of the study, which is ongoing until July 2024.

“We have had a close eye on safety and can certainly reassure all that generally this vaccine is as safe as any Covid vaccine. The risk-benefit ratio falls strongly in favour of vaccination compared with Covid-19 disease.”