Johnson & Johnson’s Covid-19 vaccine is now under evaluation for formal registration in South Africa, the first to reach that stage.
Trials show antibodies in 99% of participants.
The vaccine candidate – known as JNJ-78436735 – is delivered by a harmless virus called Adenovirus 26.
Johnson & Johnson became the first company to seek registration in SA for its Covid-19 vaccine, with the South African Health Products Regulatory Authority (Sahpra) confirming it is evaluating the application.
Earlier this month the regulator said it had “adopted approaches, which seeks to expedite access to quality, safe and efficacious vaccine to the South African public”, including provisional registration if some information it would normally require was still outstanding.
While the first results from Johnson & Johnson’s trial of the vaccine are only expected in January, the company said in October that that it led to detectable antibodies in 99% of participants.
Here’s what else we know about the vaccine now being considered for formal registration in South Africa.
It uses a modified virus as a delivery mechanism
The vaccine candidate – known as JNJ-78436735 – is delivered by a harmless virus called Adenovirus 26, a human virus uncommon in nature so most people have not developed immunity to it, reports USA Today.
The virus is really good at invading human cells, but has been modified not to replicate itself. The Johnson & Johnson vaccine uses the modified version of the virus to carry a gene from the coronavirus into the human cells. It then produces coronavirus proteins in the cells – but not the virus itself. This should help prime your immune system to attack the coronavirus when it enters your body, the New York Times reports
Other vaccines – like the Pfizer/BioNTech and Moderna vaccines –
don’t use modified viruses, but rather molecules of synthetic RNA.
Using the same adenovirus, Johnson & Johnson recently developed a Ebola vaccine candidate.
That immunisation was approved by the European Union in July.
It is currently being trialled in South Africa
From the 170 Covid-19 vaccines being tested around the world,
Johnson & Johnson’s proposed candidate is seen as one of the ten frontrunners.
It is currently in its last phase before approval – so-called phase three, when it is tested on humans.
Its proposed Covid-19 vaccine is currently in a late-stage testing among 60,000 people, including in South Africa, Brazil, Mexico, and the United States.
It briefly stopped its trials in the US after one participant fell seriously ill in September
Johnson & Johnson also recently confirmed that it will now only trial its vaccine among 40,000 people in the US –
down from the planned 60,000 –
as Covid-19 cases skyrocket in that country.
“Given the high incidence of Covid-19 among the general population,
we expect that approximately 40,000 participants will generate
the data needed to determine the safety and efficacy of our investigational Covid-19 vaccine candidate,” J&J told the Financial Times.
The company already has close to 40,000 people enrolled in the US.
On average, more than 200,000 Americans are now testing positive for the coronavirus every day,
according to data from Johns Hopkins University.
This means participants are much likelier to be exposed to the virus, testing the vaccine’s efficacy.
It could be packaged in Port Elizabeth
As many as 300 million doses of a proposed new Johnson & Johnson Covid-19 vaccine could be packaged in a Port Elizabeth factory,
from as early as in the second quarter of next year.
The US company announced a preliminary partnership with local drugmaker Aspen in November.
The local company will manage the formulation,
filling and secondary packaging of the vaccine and supply it to Johnson & Johnson.
If the vaccine is approved, and an agreement between the two companies is concluded,
Aspen could start manufacturing the vaccine in the second quarter of 2021,
Aspen’s deputy CEO, Gus Attridge .
For its part, Johnson & Johnson told SA TIMES NEWS that
it wants to allocate up to 500 million vaccine doses to lower income countries, with delivery beginning mid next year.
The vaccine only requires one dose
Unlike some of the other vaccines, which require two doses a few weeks apart, the J&J vaccine may only require one dose – which excites SA experts.
“A single dose is a big advantage for us, rather than having to get two doses,” professor Salim Abdool Karim,
who serves as the chair of the ministerial advisory committee on Covid-19, recently told Business Insider.
“If you have a single dose, you need half the medical care infrastructure.
If we choose a vaccine that is two doses, that will double the cost [because] we’ve got to buy twice as many vaccines.”
It doesn’t demand a deep freeze
Unlike the Moderna and Pfizer/BioNtech vaccines, which require low temperature freezers, J&J’s vaccine may only need regular refrigeration.
It should be cheaper than some other vaccines
Also, it should be much cheaper. In a deal with the US government, Johnson & Johnson priced its vaccine at about $10 (R150) per dose –
much lower than the Pfizer ($19 per dose) and Moderna ($25 to $37 per dose) vaccines, Forbes reported.