More than a year after people began getting coronaviruses shots, a new vaccine based on a classic, decades-old technology is expected to begin rolling out in the US this summer.
Advisers to the Food and Drug Administration are going to debate the safety and effectiveness of a vaccine developed by Novavax. It will become the fourth coronaviruses vaccine in the nation if the shot is approved.
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It's a puzzle for most people who have already received at least one shot from Moderna or Pfizer-BioNTech. Do you think now is the right time? What is the reason for bothering?
This is a moment of truth for a small group of holdouts who have been following the progress of the vaccine.
Some people can't take the vaccine and it's important to have a choice. She hopes her next shot will be from Novavax after receiving a Johnson & Johnson shot.
I'm being very careful. I'm staying at my apartment complex and not eating out. I stress the minute I wake up.
Even though Novavax lost the race to be first, company executives argue that their shot will help fill in the gaps of the vaccine campaign and help people live with the disease into the future.
They argue that their vaccine, which can stay stable at refrigerator temperatures long-term and may be better tolerated than alternatives, will have advantages once the exigencies of the swine flubate. The vaccine was not going to be an alternative for people worried about heart inflammation. There were five cases of inflammation, mostly in men, within two weeks of being vaccined, raising concern for a causality.
More than 75% of people over the age of 18 are already fully protected with the Novavax vaccine. Some of the unvaccinated are waiting for another option, but others are not interested. Novavax wants to be able to use the shot in adolescents.
The vaccine's availability is likely to be slower than previous coronaviruses, which were available days after FDA advisers met.
Testing and submission of manufacturing information about the vaccine was still in progress and would be essential to ensure the vaccine's quality and consistency for authorization. A meeting of vaccine advisers from the CDC has not been scheduled yet. John Trizzino, chief commercial officer at Novavax, said that the company would have shots ready to supply within a few weeks.
Novavax executives are still confident that the vaccine will fill a need.
"If you asked anyone in the space a year ago what would be happening now, they would have said, 'Oh, by now we'd be long past the epidemic,'" Trizzino said.
It's - - -
The Erlenmeyer flasks are in a brightly lit laboratory in Maryland. The glass containers are filled with cells from a pest called the fall armyworm moths.
The newest omicron subvariants, BA.4 and BA.5 are coronaviruses spike proteins, which are churned out by the tiny vaccine factories of the moths. Even as Novavax scientists wait for their first- generation vaccine to be authorized, they are working on new versions to be ready for any future outbreak.
The rapid development of the first vaccines is underscored by the winding path to this moment, a vaccine on the verge of authorization a year after it was shown to be effective. The growing pains of a small company that had to expand quickly are some of the factors that contribute to the time lag.
Novavax's vaccine is attractive to some people because of its older technology andTrademarkiaTrademarkiaTrademarkiaTrademarkiaTrademarkia is what made it trail other shots The shots are used against a number of diseases. The time it takes to develop them is long.
Cells inside the body of vaccine recipients are instructed to build a coronaviruses spikeProtein. The J&J shot uses a harmless virus to cause cells to make a spikeProtein. Novavax makes and purifies coronaviruses in a lab.
Scientists at Novavax started with a baculoviruses. The coronaviruses are engineered to carry genetic instructions for their build. The fall armyworm's cells are introduced into the cells of the baculoviruses. In larger vessels, researchers brew a cloud of moths cells that can produce spikes. There are 6,000-liter vats filled with insect cells in a factory in India.
Scientists purify and remove other cellular debris in order to recover the vaccine ingredient. They add detergent to make a bubble that looks similar to the virus. The immune system is revved up by the addition of an adjuvant.
The chief scientist at Novavax said he began working on the technology as a graduate student.
Smith said that he had a crazy idea when he was in graduate school. I know it's important, and I can tell you that hardly anyone shared that opinion.
The advantage of "bug cells" is that they are good at making complexproteins.
Novavax started out with disadvantages at the beginning of the Pandemic because of cool science alone. The company didn't launch a vaccine. After efforts to develop a vaccine against the respiratory syncytial virus (RSV) failed, key manufacturing capabilities were sold off to keep the company alive.
The federal program to accelerate vaccine development backed Novavax's coronaviruses vaccine. The shots were supported by the government's investment in the company. The scale-up challenges were enormous even with the cash.
At that time, we were not a developed company. Stanley C. Erck said that the company started with 100 people in the US. We had seven days a week for two years. We worked to get to the next experiment.
A new headquarters for Novavax is under construction and the workforce has exploded in the past two years. Every department shows the growth. Scientists receive samples from vaccine trials at a corridor.
About 100,000 samples were analyzed last year by a staff of 60. They have analyzed 87,000 so far this year and are hoping to double their capacity by next year.
The time it took to review the company's application for FDA authorization was due to the fact that the Serum Institute of India is manufacturing Novavax's vaccine.
Novavax lost time in manufacturing because of difficulties with testing the vaccine. Regulators want to know that the vaccine is consistent in batches and quantities.
Kathleen M Neuzil is the director of the Center for Vaccine Development and Global Health at the University of Maryland.
Emergency authorization was filed by the company.
It's - - -
Most people don't think a fourth shot will make a difference in vaccine rates. The promise of helping to close the vaccine hesitancy gap has been one of the selling points for Novavax executives.
There is a group of people in the US who connect on social media and hold out for the vaccine because they can't or won't take existing vaccines. The shot can be used as a booster or global. In more than 40 countries, it has been approved. If it is eventually authorized in adolescents and children, that could lead to more use.
There are a lot of people who haven't gotten boosted who are still nervous about the messenger RNAs. There is a niche for people who feel safer with the Novavax shot, according to a vaccine expert.
Adding another option to the arsenal could be important for the future.
In a world in which there are many choices, some people had hoped the protein shot would be an attractive option, especially since it has been shown to increase the risk of heart inflammation in young men. The five cases of heart inflammation identified in Friday's FDA review support a concern for causality.
Novavax disagreed with the FDA's conclusion that the vaccine and placebo groups had the same rate of heart inflammation. The company believes there is not enough evidence to establish a relationship.
The revelation that the same rare heart risk may exist with this vaccine is disappointing for Randy Cox.
Cox has been waiting on Novavax for months because he is afraid that the vaccine could cause a cyst in his heart and make it worse. Cox kept his mask on and wiped his groceries down despite the fact that most of the country was vaccine free.
Cox said that learning about heart inflammation associated with the Novavax shot came as a shock.
He watched enviously as other countries approved the vaccine. When Canada authorized the Novavax shot, Cox applied for a passport thinking he could make the five-hour drive, but was told that people who weren't Canadian citizens couldn't get a shot.
Cox said he is going to have to dig into the data, watch the FDA meeting and think about whether he still wants Novavax, or if he would settle for the Pfizer- BioNTech vaccine that has been more widely used.
Cox was really sad.
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