Johnson & Johnson expects the critical results of its Covid-19 vaccine study to be released in just two weeks – a potential boon to efforts to protect Americans from the coronavirus – but most likely not as many doses will be given this spring as the federal government had promised due to unexpected delays in manufacturing.
If the vaccine can protect people strongly against Covid-19, as some outside scientists expect, it would offer great advantages over the two US-approved vaccines. Unlike products that require two doses, Johnson & Johnson may only need one, making logistics a lot easier for local health departments and clinics that are struggling to hug. In addition, the vaccine can remain stable in the refrigerator for months while the others have to be frozen.
However, the encouraging prospect of a third effective vaccine is tempered by apparent delays in the company’s production. In the company $ 1 billion contract Johnson & Johnson, which was signed with the federal government in August, pledged to have 12 million doses of its vaccine ready by the end of February, bringing the total to 100 million doses by the end of June.
Federal officials were told that the company was up to two months behind the original production schedule and won’t catch up until the end of April, when, according to two known people, it should have dumped more than 60 million cans with the situation who were not authorized to to discuss it publicly. Carlo de Notaristefani, senior manufacturing advisor for Operation Warp Speed, the federal vaccine development program, admitted a delay but said the company may be able to meet original production targets by March.
“I agree there was a problem,” said Dr. de Notaristefani. But he added, “Pharmaceutical manufacturing is not a black box where you turn the key and start counting.”
Any delay could be critical as the federal government has only secured enough vaccine doses to vaccinate 200 million of the roughly 260 million eligible adults in the first half of this year. With the nation hit by the biggest surge in coronavirus yet, with the death toll rising to 4,000 a day, Americans desperate to get vaccinated line the sidewalks outside vaccination centers.
Fears about the virus have only increased with the scientific discovery last month that the country has been colonized with a new, highly contagious variant. On Tuesday the Trump administration did announced It would no longer hold back vaccine supplies for second doses in order to get more people to vaccinate, at least partially, faster.
Dr. Paul Stoffels, chief scientist at Johnson & Johnson, said he expected data from clinical trials to show whether his company’s vaccine is safe and effective in late January or early February. However, he declined to provide details about the company’s production capacity.
“We are currently not ready to publish the numbers month after month as we are in discussion with the F.D.A.,” he said.
If the data is positive and the Food and Drug Administration approves the emergency vaccine, he added, “Hopefully sometime in March we can make a contribution to the country’s vaccination campaign.”
Johnson & Johnson’s schedule slipping is not uncommon given the breakneck pace of vaccine development amid the worst pandemic in a century. The delay also underscores the unrealistic promise of Operation Warp Speed.
The premise of the program was that the federal government would cover the cost of development and manufacturing so that vaccine manufacturers could mass-produce doses before the vaccines were proven to work. Moncef Slaoui, Chief Scientific Advisor for Warp Speed, said in December that the Johnson & Johnson vaccine would be a game changer in the pandemic.
At a press conference on Tuesday, Dr. Slaoui, however, that the company is expected to be in the single-digit million range instead of the 12 million cans scheduled in the contract by the end of February. He also said the company “tried to get that number as close to a double-digit number as possible, and then a larger number in March and a much larger number in April.” Another person familiar with the company’s advancements said it was ready to only be delivering maybe three or four million doses of its vaccine by the end of next month.
In a statement, a Johnson & Johnson spokesman said, “We are confident we can meet our contractual obligations to deliver our vaccine candidate to the US government.”
Dr. en Notaristefani, chief of production for Operation Warp Speed, said the government’s contracts with vaccine manufacturers were made at a time of great uncertainty, understanding that unforeseen obstacles could affect schedules. “Numbers are never set in stone when you start a new process,” he said, adding that the company had to move manufacturing from the Netherlands to a facility in Baltimore. “I really think that technically they couldn’t make it earlier.”
Dr. Marcus Plescia, the chief medical officer for the Association of State and Territorial Health Officials, said state health officials are clearly excited about Johnson & Johnson’s single-dose vaccine.
While the exact order of vaccine recipients may vary from state to state, most doctors and residents of long-term care facilities will come first. If you want to understand how this decision is made, This article will help.
Life will only get back to normal once society as a whole receives adequate protection against the coronavirus. Once countries approve a vaccine, they can only vaccinate a few percent of their citizens in the first few months. The unvaccinated majority remain susceptible to infection. A growing number of coronavirus vaccines show robust protection against disease. However, it is also possible for people to spread the virus without knowing they are infected because they have mild or no symptoms. Scientists don’t yet know whether the vaccines will also block the transmission of the coronavirus. Even vaccinated people have to wear masks for the time being, avoid the crowds indoors and so on. Once enough people are vaccinated, it becomes very difficult for the coronavirus to find people at risk to become infected. Depending on how quickly we as a society achieve this goal, life could approach a normal state in autumn 2021.
Yeah, but not forever. The two vaccines that may be approved this month clearly protect people from contracting Covid-19. However, the clinical trials that produced these results were not designed to determine whether vaccinated people could still spread the coronavirus without developing symptoms. That remains a possibility. We know that people who are naturally infected with the coronavirus can spread it while they don’t have a cough or other symptoms. Researchers will study this question intensively when the vaccines are introduced. In the meantime, self-vaccinated people need to think of themselves as potential spreaders.
The vaccine against Pfizer and BioNTech, like other typical vaccines, is delivered as a shot in the arm. The injection is no different from the ones you received before. Tens of thousands of people have already received the vaccines, and none of them have reported serious health problems. However, some of them have experienced short-lived symptoms, including pain and flu-like symptoms that usually last a day. It is possible that after the second shot, people will need to have a day off to work freely or go to school. While these experiences are not pleasant, they are a good sign: they are the result of your own immune system’s encounter with the vaccine and a strong reaction that ensures lasting immunity.
No. Moderna and Pfizer vaccines use a genetic molecule to boost the immune system. This molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse with a cell, allowing the molecule to slide inside. The cell uses the mRNA to make proteins from the coronavirus that can stimulate the immune system. At any given moment, each of our cells can contain hundreds of thousands of mRNA molecules that they produce to make their own proteins. As soon as these proteins are made, our cells use special enzymes to break down the mRNA. The mRNA molecules that our cells make can only survive a few minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a little longer, so the cells can make extra viral proteins and trigger a stronger immune response. However, the mRNA can hold for a few days at most before it is destroyed.
“You can get it and you’re done,” he said. “Everyone is excited to have it out there. It has a lot of potential. “
But even if Johnson & Johnson’s vaccine fails, it won’t be enough, said Dr. Plescia. He predicted that state health departments would need a total of four vaccines over the next six months if they are to meet their goals of offering a vaccine to every American who wants one.
“Otherwise the public will be very frustrated because they are willing to open it and there is insufficient supply to do so,” said Dr. Plescia.
Johnson & Johnson is by no means alone in its manufacturing delays. Dr. Pfizer chief executive Albert Bourla told investors last fall that his company had agreed to ship 40 million doses of its vaccine to the federal government in 2020, provided it was shown to be successful in clinical trials. In the end, the company only had half as many ready for dispatch.
Nobody – including company executives – knows if the Johnson & Johnson vaccine will work. However, Lynda Coughlin, a virologist at the University of Maryland School of Medicine who is not involved in the study, said the vaccine design and the results of early studies made her optimistic.
“Hopefully the Johnson & Johnson results will really knock it out,” she said.
The Johnson & Johnson Covid vaccine is fundamentally different from the approved vaccines from Moderna and Pfizer-BioNTech. These two are made up of genetic molecules trapped in oily bubbles. Johnson & Johnson built their vaccine from a virus that causes colds and is known as adenovirus.
When testing the vaccine on monkeys, the researchers found that a single shot was enough to protect the animals from infection. When they tried different formulations of the vaccine in early clinical trials, they were delighted to see that the vaccine produced a strong antibody response with a single dose.
When the results of the early clinical trials became known over the summer, the company had to make a hard-hitting decision: move on to a two-dose clinical trial that was most likely to be successful, or try a single dose far more useful for getting shots out to the masses – if it worked. The company decided to throw the dice with a single shot attempt.
“We know from vaccination campaigns that the simpler the logistics, the more successful the program,” said Dr. Dan Barouch, a virologist at Beth Israel Deaconess Medical Center who pioneered adenovirus vaccines in the early 2000s and worked with researchers at Johnson & Johnson’s trial.
If many people started developing immunity to a single dose, it could make it harder for the virus to get from person to person, lowering the high rates of new cases and reducing the burden of the pandemic.
“A single-dose vaccine would have a huge public health impact, of course for low-income countries, but also for high-income countries,” said Ruth Faden, professor of biomedical ethics at Johns Hopkins University.
While other vaccine developers were quick to move into late-stage studies, Johnson & Johnson deliberately slowed down to focus on moving its vaccine manufacture forward. In a facility in the Netherlands, researchers grew cells in which their adenoviruses could multiply. Scientists adjusted the chemistry in huge vats and found a recipe for making the vaccine quickly and reliably.
Johnson & Johnson also began working with other companies early on to prepare to manufacture the vaccine worldwide. In April, it announced a partnership with Emergent BioSolutions in Maryland to manufacture the vaccine for the United States. Johnson & Johnson researchers visited Emergent BioSolutions starting this month to prepare to manufacture the adenoviruses.
“It was much more than a paper exercise:” Here is the recipe, follow this “, said Remo Colarusso, Vice President at Janssen Supply Chain.” This is a complex production. “
In the fall, Emergent BioSolutions grew cells that spit out new adenoviruses. At Johnson & Johnson announced the start In the last phase 3 study, executives made aggressive projections. “We are now determined to deliver more than a billion doses in 2021 and beyond,” said Dr. Stoffels at a press conference in September.
The company then secured additional contracts to supply the vaccine to countries around the world. In 2021, Johnson & Johnson promised to provide 200 million doses to Covax, an international partnership that aims to bring coronavirus vaccines to countries they otherwise could not afford. Covax will deliver another 300 million in 2022.
Shortly after Johnson & Johnson began its trial, cases increased worldwide. All Phase 3 clinical trials of Covid vaccines have been accelerated as the trials only end after a certain number of volunteers – from both the placebo and vaccinated groups – become ill. In November, the vaccine trials with Pfizer-BioNTech and Moderna delivered impressive results with an efficacy rate of around 95 percent.
The F.D.A. Both vaccines were approved for the US and other countries soon followed suit. However, both of these vaccines had some major shortcomings that soon became irreversible. Both vaccines must be frozen so that they do not break down. Once they reach a hospital or clinic, they must be used before they spoil. In New York City and elsewhere, unused vaccines have ended up in the trash.
Once the data collection is completed in late January or early February, an advisory board will review the data and report to Johnson & Johnson on its safety and efficacy analysis. F.D.A. Regulators are evaluating manufacturing data weeks before Johnson & Johnson’s likely application for emergency approval. Hiccups, as small as mold in any part of a plant, can cause further delays.
Katie Thomas contributed to the coverage.