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A volunteer receives an injection for a possible COVID-19 vaccine at Baragwanath Hospital on June 28, 2020, in Soweto, South Africa.
- Johnson & Johnson’s Covid-19 vaccine is now under evaluation for formal registration in South Africa, the first to reach that stage.
- The tests show antibodies in 99% of the participants.
- The vaccine candidate, known as JNJ-78436735, is administered by a harmless virus called Adenovirus 26.
- For more articles, go to www.BusinessInsider.co.za.
Johnson & Johnson became the first company to apply for registration in South Africa for its Covid-19 vaccine, and the South African Health Products Regulatory Authority (Sahpra) confirmed that it is evaluating the application.
Earlier this month, the regulator said it had “taken approaches, which seek to accelerate access to quality, safe and effective vaccines for the South African public,” including interim registration if any information it would normally require is still pending.
While the first results of Johnson & Johnson’s vaccine trial are only expected in January, the company said in October that it led to detectable antibodies in 99% of participants.
Here’s what we know about the vaccine that is now being considered for formal registration in South Africa.
It uses a modified virus as a delivery mechanism.
The candidate vaccine, known as JNJ-78436735, is delivered by a harmless virus called Adenovirus 26, a rare human virus in nature, so most people have not developed immunity against it, USA Today reports.
The virus is very good at invading human cells, but it has been modified to not replicate. The Johnson & Johnson vaccine uses the modified version of the virus to carry a coronavirus gene into human cells. It then produces coronavirus proteins in cells, but not the virus itself. This should help prime your immune system to attack the coronavirus when it enters your body, reports the New York Times.
Other vaccines, such as the Pfizer / BioNTech and Moderna vaccines, do not use modified viruses, but rather synthetic RNA molecules.
Using the same adenovirus, Johnson & Johnson recently developed a candidate Ebola vaccine. That immunization was approved by the European Union in July.
It is currently being tested in South Africa.
Of the 170 Covid-19 vaccines being tested around the world, the candidate proposed by Johnson & Johnson is considered one of the ten pioneers. It is currently in its final phase before approval, the so-called phase three, when tested in humans.
Its proposed Covid-19 vaccine is currently in an advanced stage of testing among 60,000 people, including in South Africa, Brazil, Mexico and the United States.
He briefly stopped his trials in the US after a participant became seriously ill in September
Johnson & Johnson also recently confirmed that it will now only test its vaccine among 40,000 people in the US, compared to an expected 60,000, as Covid-19 cases skyrocket in that country.
“Given the high incidence of Covid-19 among the general population, we expect approximately 40,000 participants to generate the data necessary to determine the safety and efficacy of our investigational Covid-19 vaccine candidate,” J&J told the Financial Times. The company already has about 40,000 people registered in the US.
On average, more than 200,000 Americans now test positive for the coronavirus every day, according to data from Johns Hopkins University. This means that participants are much more likely to be exposed to the virus, testing the efficacy of the vaccine.
Can be packed in Port Elizabeth.
Up to 300 million doses of a proposed new Johnson & Johnson Covid-19 vaccine could be packaged at a Port Elizabeth factory, starting 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 will supply it to Johnson & Johnson.
If the vaccine is approved and an agreement is concluded between the two companies, Aspen could begin manufacturing the vaccine in the second quarter of 2021, Aspen Deputy CEO Gus Attridge told Business Insider South Africa.
For its part, Johnson & Johnson told Business Insider SA that it wants to allocate up to 500 million doses of vaccines to lower-income countries, with delivery beginning in the middle of 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 SA experts are excited about.
“A single dose is a huge advantage for us, rather than having to get two doses,” Professor Salim Abdool Karim, who serves as chair of the ministerial advisory committee on Covid-19, recently told Business Insider.
“If you have a single dose, you need half the health care infrastructure. If we choose a two-dose vaccine, that will double the cost. [because] we have to buy twice as many vaccines. “
Does not require a deep freeze
Unlike Moderna and Pfizer / BioNtech vaccines, which require low-temperature freezers, the J&J vaccine may only need regular refrigeration.
It should be cheaper than some other vaccines.
Also, it should be much cheaper. In an agreement with the U.S. government, Johnson & Johnson priced its vaccine at approximately $ 10 (R150) per dose, much lower than the Pfizer ($ 19 per dose) and Moderna ($ 25 per dose) vaccines. $ 37 per dose), Forbes reported.
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