‘Green Light’: Potentially Game-Changing One-Shot Vaccine By Johnson & Johnson Eyes Imminent FDA Approval
America – and the rest of the world – could soon be getting yet another vaccine added to the arsenal against COVID-19… and this one could very well be the game-changer many have been hoping for.
Tomorrow, Johnson & Johnson’s vaccine is set to be discussed and potentially approved for emergency use in the States, but it’s already looking great for what would end up being many countries’ fourth vaccine.
In a number of documents released by the Food and Drug Administration yesterday, in fact, the vaccine was proved to be “safe and highly effective” (as much as 86%) against COVID-19’s most severe outcomes.
“The FDA went so far as to say the vaccine has a ‘favourable safety profile’ with no specific safety concerns identified that would preclude the issuance of an emergency use authorization,” former Department of Defense immunologist John Grabenstein told NBC News on Wednesday. “In other words, green light.”
The promising statistics don’t end there: the vaccine showed a 72% overall efficacy rate in the US and an improved 64% in South Africa, where a very contagious variant is currently wreaking havoc.
Side effects of the vaccine were generally limited to arm pain, headache and fatigue. Moreover, no deaths or hospitalisations were reported among study participants who received the jab after 28 days.
Because of all this, it’s now very widely expected that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will vote to recommend authorisation of the vaccine in the US. And while the FDA is not technically required to go along with this recommendation, it nearly always does.
“If authorised, we are ready to roll out this vaccine without delay,” Jeff Zients, coordinator for the Biden administration’s COVID-19 task force, said during a media briefing Wednesday.
And while initial supply of the vaccine might be limited at first – the US is scheduled to get four million doses by the end of February instead of the initially-promised 12 million – Johnson & Johnson has said it plans to fulfill its promise of 100 million doses by the end of June.
Beyond Johnson & Johnson’s promising study results, however, many are hailing the vaccine as a potential game-changer in the world’s battle against COVID-19 due to the simple fact that patients only need one dose.
Less than two weeks ago, in fact, Health Minister Chris Fearne had gone on TV to celebrate the imminent vaccine’s welcomed push.
“In March, we’re going to have the fourth vaccine, that of Johnson & Johnson,” Fearne had announced during a late-night interview on XTRA. “We have around 250,000 doses of that vaccine which we can add to the rest.”
“This means that, thanks to this vaccine and all the others, we’ll be in a much better position come April,” Fearne continued. “The initial plan was to open vaccinations to the general public towards the end of May. But since we’re already a couple of weeks ahead and are getting the Johnson & Johnson vaccine in March, we can approach even further. This means we might not open up to the general public towards the end of May, but maybe even closer to the beginning of May.”
What do you make of this? Let us know in the comments below
READ NEXT: As France Recommends Single Vaccine Dose For Previous COVID-19 Patients, Malta Doubles Down On Original Plan
