Daily Mail Online: LONDON, England – The US is getting a third vaccine to prevent COVID-19, as the Food and Drug Administration on Saturday cleared a Johnson & Johnson shot that works with just one dose instead of two.
Health experts had been anxiously awaiting a one-and-done option to help speed vaccinations, as they race against a virus that already has killed more than 510,000 people in the US and is mutating in increasingly worrisome ways.
The FDA panel voted unanimously – 22 to zero – in favor of the vaccine saying J&J’s vaccine offers strong protection against what matters most: serious illness, hospitalizations and death.
A third vaccine is seen as a vital means to ramp up the immunization rate.
Together with Pfizer and Moderna doses, it gives the US enough doses to fully vaccinate every adult in the country.
In large clinical trials that spanned three continents, the J&J vaccine’s efficacy against severe disease was 85.9 percent in the United States, 81.7 percent in South Africa, and 87.6 percent in Brazil, where the variants of most concern are spreading.
Overall, among 39,321 participants across all regions, the efficacy against severe Covid-19 was 85.4 percent, but it fell to 66.1 percent when including moderate forms of the disease.
Crucially, analyses of various demographic groups revealed no marked differences across age, race, or people with underlying conditions.
“The more vaccines that have high efficacy that we can get into play, the better,” Dr Anthony Fauci, the top US infectious disease expert, said ahead of the FDA´s ruling.
Shipments of a few million doses to be divided among states could begin as early as Monday.
With 100 million doses of the single-shot expected by the end of June, the additional doses could boost the US stockpile enough to have enough vaccine to inoculate every American.
But Johnson & Johnson admitted earlier this month that only three or four million doses will be available immediately upon authorization but with some 800,000 of that expected to go directly to pharmacies., 70,000 would be sent to community centers; and 90,000 would go to federally qualified health centers.
President Joe Biden called the FDA approval “exciting news for all Americans, and an encouraging development in our efforts to bring an end to the crisis”.
“We know that the more people get vaccinated, the faster we will overcome the virus, get back to our friends and loved ones, and get our economy back on track…. But I want to be clear: this fight is far from over.
“There is light at the end of the tunnel, but we cannot let our guard down now or assume that victory is inevitable. We must continue to remain vigilant, act fast and aggressively, and look out for one another — that is how we are going to reach that light together,” he continued.
By the end of March, J&J has said it expects to deliver 20 million doses to the US, and 100 million by summer. Together with Moderna and Pfizer it’s enough for every person in the US.
Saturday’s figures show there are currently 51,116 people in hospital with virus and 2,137 deaths in the last 24 hours
On Friday, during a visit to Houston, Biden described the federal government’s mass inoculation drive as “the most difficult operational challenge this nation has ever faced logistically”.
He said there were to be expected challenges in reaching people in remote areas, and in persuading others who were ‘hesitant to take the shots.’
“We all know there’s a history in this country of subjugating certain communities to terrible medical and scientific abuse, but if there’s one message that needs to cut through all this: The vaccines are safe. I promise you,” Biden said.
The panel was particularly glad that vaccine can be easily stored, at just refrigerator temperatures of between 35.6 and 46.4F, making distribution easier than that of the Pfizer Inc/BioNTech SE and Moderna Inc vaccines that use mRNA technology and must be shipped and stored frozen
That is ‘very practical for rural areas in the US and across the world,’ said one of the panelists, Dr Ofer Levy, a professor at Harvard Medical School and director of Boston Children’s Hospital’s vaccine program.
J&J’s vaccine also had a low rate of side effects in a 44,000-person trial. Sixty-one percent of participants had some reaction, but just 2.3 percent were considered severe.
J&J’s vaccine uses a common cold virus known as adenovirus type 26 to introduce coronavirus proteins into cells in the body and trigger an immune response.
Three to four million doses of the vaccine are expected to be rolled out next week.
Most people who had side effects had nausea, fatigue, headaches, body aches or fevers.
There had been no severe allergic reactions to the vaccine documented in the trial data prior to Friday, but Johnson & Johnson scientists revealed that one person had since had an anaphylactic reaction to the shot.
A Johnson & Johnson scientist works in a laboratory during the development and testing of the Janssen coronavirus disease (COVID-19) vaccine
The vaccine was 66 percent effective at preventing moderate-to-severe cases of COVID-19 compared with a placebo in the context of trials in North America, South America and South Africa.
‘It gets way over the bar and it’s nice to have a single-dose vaccine,’ said Dr Stanley Perelman, another panelist and coronavirus expert at the University of Iowa.
He noted, however, that it is “a little challenging to know how to use it clinically right now”.
Dr Perelman did not elaborate on that, beyond to say that we are in a “shifting environment” but was perhaps referring to the possibility that Johnson & Johnson’s vaccine ends up being a two-dose vaccine.
The nation will now have a third vaccine from which to protect citizens with the Johnson & Johnson shot only requiring a single shot compared to Pfizer and Moderna’s jabs
By the end of March, J&J has said it expects to deliver 20 million doses to the US, and 100 million by summer.
J&J also is seeking authorization for emergency use of its vaccine in Europe and from the World Health Organization.
Worldwide, the company aims to produce about 1 billion doses globally by the end of the year.
On Thursday, the island nation of Bahrain became the first to clear its use.
The US Centers for Disease Control and Prevention said 72,806,180 doses of COVID-19 vaccines had been administered in the country as of Saturday morning and it had distributed 96,402,290 doses.
The tally is for both the Moderna and Pfizer/BioNTech vaccines as of 6am Saturday, the agency said. Both the Pfizer and Moderna vaccines involve two doses.
The CDC on Friday had reported a tally 70,454,064 vaccines doses administered and 94,300,910 doses distributed.
The agency said that as of Saturday, 48,435,536 people had received at least one vaccine dose while 23,698,627 had received the two doses.
A total of 7,043,540 vaccine doses have been administered in long-term care facilities, the agency said.
The United States has recorded about 28.5 million coronavirus cases and 510,373 deaths.
Daily case numbers are roughly where they were in October and well below the single-day record of about 300,000 infections set in early January, but federal health officials are warning impatient governors not to relax pandemic control measures, fearing a recent steep drop in cases and deaths could be about to level off.
Concerns have been raised after the seven-day average for new cases — 69,483 as of early Saturday — has been creeping upwards.
J&J VACCINE: THE FACTS
HOW EFFECTIVE WAS IT IN A LARGE STUDY?
Results from a trial of about 44,000 participants show the J&J vaccine was 66% effective in preventing moderate-to-severe COVID-19 globally.
A review of available data by an independent safety monitoring board indicated that a single-dose of the COVID-19 vaccine was generally well-tolerated.
DATA IN SOUTH AFRICA
In South Africa, where 95% of the cases in the trial were due to infection with the highly contagious B.1.351 coronavirus variant, the vaccine was 64% effective in preventing moderate-to-severe COVID-19 28 days after inoculation.
About 6,000 people in South Africa took part in the trial.
DATA IN UNITED STATES
The level of protection from the vaccine against moderate-to-severe COVID-19 infection was 72% in the United States after 28 days.
DATA IN LATIN AMERICA
The shot was 66% effective at stopping moderate-to-severe cases in Brazil after 14 days and 68% after 28 days. It was 66% effective in Latin America overall, which involved nearly 18,000 people in Argentina, Brazil, Chile, Colombia, Mexico and Peru.
About 34% of trial participants were over age 60.
17.2% of participants in the trial were Black, 8.3% were American Indian or Alaskan Native, 2.5% were Asian and 45% were Hispanic or Latino.
The FDA said the most common reactions were injection site pain at 48.6%, headache at 39%, fatigue at 38.2% and aches and pains at 33.2%. Other side effects included a fever in 9% of participants and a high fever in 0.2% of those who received the vaccine.
HOW DOES IT DIFFER FROM THE PFIZER AND MODERNA VACCINES?
The Pfizer/BioNTech and Moderna vaccines use new messenger RNA technology to create an immune response and both require two shots. The one-shot J&J vaccine involves a more conventional approach, using a common cold virus to introduce coronavirus proteins into cells to trigger an immune response.
J&J’s vaccine remains stable for at least three months at normal refrigerator temperatures, while the Moderna vaccine must be shipped frozen and the Pfizer/BioNTech option must be shipped and stored at even colder sub-Arctic temperatures.
These factors make it easier to vaccinate larger numbers of people, even in areas with poor transportation and storage infrastructure.
Pfizer/BioNTech and Moderna vaccines were about 94%-95% effective in trials conducted in the United States where variants were not circulating.
HOW DOES IT RANK NEXT TO THE OTHERS?
Both mRNA vaccines showed higher efficacy rates in their trials than J&J’s vaccine, but experts cautioned against drawing too much of a distinction between the vaccines because the trials had different endpoints and J&J’s was conducted while highly transmissible new variants of the virus were circulating.
Novavax Inc, which is testing its vaccine in South Africa, said it was 60% effective at preventing mild, moderate and severe COVID-19 in patients who did not have HIV. It said about 90% of cases in the study involved the new South African variant. The mid-stage South Africa trial included 4,400 patients.
The vaccine developed by AstraZeneca with Oxford University provided only minimal protection against mild-to-moderate COVID-19 from the South African variant in a relatively small trial. There was no data yet on its effectiveness in preventing severe disease in people who were infected by the variant because the study involved mostly young adults not considered to be at high risk for serious illness.
J&J expects to produce at least a billion doses of its vaccine in 2021 and has signed supply deals for most of that.
The United States agreed to pay over $1 billion for 100 million doses and may purchase an additional 200 million doses.
Other deals include 22 million doses for Mexico, 9 million for Colombia, 30 million the UK, 4 million to South Korea and 400 million for the European Union. It plans to supply 500 million to poorer countries, working with the COVAX alliance.