A one-shot vaccine could be in use by February if Johnson & Johnson’s jab is approved, according to Operation Warp Speed leader Dr Moncef Slaoui.
Slaoui on Wednesday said the Janssen could prove to be a ‘game-changer’ for the United States, which has recorded more than 19.6 million infections and at least 340,956 deaths.
According to Slaoui, Phase 3 trial recruitment for the vaccine has been completed and Johnson & Johnson is currently working with the Operation Warp Speed team to accelerate the availability of the vaccine doses.
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A one-shot vaccine could be in use by February if Johnson & Johnson’s jab is approved, according to Operation Warp Speed leader Dr Moncef Slaoui (pictured on Wednesday)
Single-dose shots would mean faster rollout, and that people would likely be protected from coronavirus in a matter of weeks after the injection – rather than the about one-month period it takes for Moderna or Pfizer‘s shots to reach their protective peak.
Slaoui also announced that the US is expected to approve the low-cost AstraZeneca/Oxford vaccine in April.
The Operation Warp Speed chief advisor, told reporters that US trials and assessments would be complete for approval ‘sometime in early April’.
‘Several tens of millions of doses will have been manufactured… and therefore will be available for use if the data supports its approval,’ he said.
He did not allege that Britain rushed its decision and praised Britain’s MHRA regulatory agency as ‘science-based’.
‘Therefore I am not raising any question as to the decision that they have made,’ he said.
‘Having said that, the requirements of the decision process as we have built it here in the US is what I can really comment on.’
Earlier this month, Johnson & Johnson said it had enrolled about 45,000 participants for the first late-stage trial of its COVID-19 single-dose vaccine candidate and that it expects interim data by late-January.
Earlier this month, Johnson & Johnson said it had enrolled about 45,000 participants (one participant pictured) for the first late-stage trial of its COVID-19 single-dose vaccine candidate and that it expects interim data by late-January
The US has a contract with J&J for 100 million doses of its COVID-19 vaccine, with the option to buy another 200 million.
The enrollment of 45,000 participants in J&J’s trial means it can focus all its energy and resources on vaccinating and gathering data on trial participants
Now, it will face a waiting game.
A sufficient number of trial participants have to develop COVID-19 for J&J to assess whether there were significantly fewer cases among people who got the real vaccine, compared to the placebo.
J&J’s study, named Ensemble, is being conducted by its unit Janssen, the drugmaker said in a statement.
The company also confirmed that it plans to submit an emergency use authorization application to the US Food and Drug Administration (FDA) in February if the data from the study is safe and effective.
The Ensemble trial was paused for over a week in October after a patient developed an ‘unexplained illness’ during the study.
The company later said it would resume the trial after an evaluation found no clear cause for the illness.
Meanwhile, the US has only vaccinated a total of 2.6 million people, according to data from the Centers for Disease Control and Prevention (CDC).
The Trump administration’s Operation Warp Speed had goals to vaccinate 20 million people by the end of 2020.
More than 12 million doses have been shipped to the US, but the distribution of the vaccines are moving slowly.
‘We agreed that the number is lower than what we hoped for,’ Slaoui said during a Wednesday briefing.
‘We know that it should be better and we are working hard to make it better,’ he added, of the distribution process.
The vaccine rollout in the US lags behind other wealthy nations. In the 16 days since the US began vaccinating people, 2,589,125 Americans have gotten their first dose.
That means an average of about 40 out of every 100,000 people in the US are getting vaccinated a day, compared to 60 per capita in the UK, which approved the Oxford University-developed vaccine made by AstraZeneca on Wednesday.
President-elect Joe Biden criticized the Trump administration Tuesday for the pace of distributing COVID-19 vaccines and predicted that ‘things will get worse before they get better’ when it comes to the pandemic.
‘We need to be honest – the next few weeks and months are going to be very tough, very tough for our nation. Maybe the toughest during this entire pandemic,’ Biden said during remarks in Wilmington, Delaware on Tuesday.