Beth Israel researcher awaits approval of the COVID-19 vaccine he helped create – The Boston Globe

So much is at stake. If the vaccine proves safe and effective, it could quickly become the third cleared for emergency use by the US government, which has ordered 100 million doses and has an option to buy 200 million more. Like the Pfizer-BioNTech and Moderna vaccines authorized by the Food and Drug Administration last month, it uses new technology. But it has two distinct advantages. It requires only one shot, not two, and doesnt need to be shipped frozen, as they do, which should simplify a rapid rollout.

Barouch, 47, says hes cautiously optimistic. The Johnson & Johnson vaccine relies on a design he pioneered nearly 20 years ago for two experimental vaccines that have shown promise against HIV and Zika and a third that won approval from the European Union in July to prevent Ebola. Unlike those efforts, however, this vaccine was created during the worst epidemic in a century, one that quickly upended life around the world.

The experience of developing a vaccine in a pandemic was truly surreal, Barouch said in a Zoom interview from his 10th-floor office in a building in the Longwood Medical Area, his white coat and a spare necktie hanging from a hook on the door. We have 4,000 people dying every day now [in the United States]. Think of it, every day we have a 9/11.

Last February, soon after the coronavirus began appearing in the United States, Barouch told the Globe that multiple vaccines would be needed to vanquish it because no single drug firm could produce enough doses to protect everyone.

Although Johnson & Johnson is one of the worlds biggest companies and has collaborated on a potential HIV vaccine with Barouchs lab for almost a decade, it is a relative newcomer in the vaccine market. The US government has pledged more than $1 billion to manufacture and deliver the firms coronavirus vaccine, which the company has agreed to provide on a nonprofit basis during the pandemic.

Dr. Moncef Slaoui, the outgoing head of Operation Warp Speed, the federal program that bankrolled several vaccine candidates to spur development and manufacturing, said last month that Johnson & Johnsons one-shot vaccine would be a game changer.

The Pfizer-BioNTech and Moderna vaccines require two doses a few weeks apart, and their slow deployment so far has caused widespread frustration among health officials and the public. As of Friday nearly 10.6 million people in the United States have gotten at least one dose of either vaccine, according to the Centers for Disease Control and Prevention, far below federal officials goal of at least 20 million by the end of 2020. The vaccines were the first to use a new technology called messenger RNA and were a remarkably 95 percent effective at preventing COVID-19 in late-stage trials.

Production of the vaccine by Johnson & Johnsons subsidiary, Janssen, is behind schedule because of unexpected manufacturing delays, according to news reports. At a news conference Tuesday, Slaoui said that instead of 12 million doses anticipated in the contract with the firm by the end of February, Johnson & Johnson was likely to have in the single-digit millions. If regulators approve the vaccine, distribution could start in February.

Johnson & Johnson said in a statement Wednesday that it is premature to discuss vaccine supply specifics but that the New Brunswick, N.J.-based company remains confident in our ability to meet our 2021 supply commitments. The firm has set a goal of delivering 1 billion doses worldwide this year.

Ordinarily, vaccines take years, if not decades, to develop. Creating a new vaccine and getting it into peoples shoulders in only a year or so is breathtakingly fast.

Barouch, who oversees a lab of about 60 researchers, seems to have spent much of his life preparing for this moment.

Although he enjoyed playing classical music growing up in Potsdam, N.Y., and passed that interest on to his two school-age daughters (both study violin and play with him at their Newton home), he eventually opted to focus on medicine.

After graduating from Harvard, he was named a Marshall Scholar and studied at Oxford University in England under Sir Andrew McMichael, a world-famous biomedical researcher known for his work on T cell responses to viral infections such as influenza and HIV. Barouch completed his PhD in immunology in just two years.

He returned to Harvard, where he earned his medical degree and met his future wife, a classmate who stored her microscope in a locker next to his. (Dr. Fina Barouch is an ophthalmologist.) He finished his clinical training in internal medicine and infectious diseases at Massachusetts General Hospital and Brigham and Womens Hospital while completing a postdoctoral research fellowship in the lab of the HIV pioneer Dr. Norman Letvin.

Soon after opening his own research lab in 2002, Barouch set a characteristically ambitious goal: creating a vaccine for HIV. Although antiretroviral drugs have made HIV a manageable infection since the late 1990s, the virus continues to exact a devastating toll, particularly in developing countries. About 38 million people were living with the virus worldwide in 2019, according to the World Health Organization.

Following many failed efforts by other scientists, Barouch chose a new approach: using another virus to deliver HIV proteins into cells to stimulate an immune response. By 2007, he had picked a relatively rare virus that causes colds, adenovirus serotype 26 or Ad26 as a Trojan horse to penetrate human cells and generate HIV antibodies without making people sick.

In experiments on monkeys, the Ad26 vaccine provided protection against HIV. In early-stage trials on humans, it was safe and stimulated a robust immune response in blood samples. Two late-stage trials are underway to see if it protects people from contracting HIV, which mutates rapidly and is considered far more challenging than the coronavirus.

Barouchs lab collaborated on the HIV vaccine with Crucell, a Dutch biotech acquired by Johnson & Johnson in 2011. Maria Grazia Pau, a Crucell biologist who began working with him nearly 20 years ago and now helps run Johnson & Johnsons HIV program, describes him as brilliant and energetic.

Theres not a single e-mail from me that he doesnt reply to within the same day or, at a maximum, the day after, she said in a Zoom call from her office in Leiden, Netherlands.

Although Barouchs lab is still working on potential vaccines against HIV and other diseases, it pivoted to COVID-19 a year ago. On Jan. 10, 2020, he hosted his labs annual retreat at the Museum of Science. Amid presentations and refreshments, he and other researchers discussed reports of a puzzling cluster of 41 cases of pneumonia in Wuhan, China.

We thought it was important, Barouch recalled. Never in our wildest imagination did we think it would grow to 90 million cases [worldwide] a year later.

That Friday night, Chinese scientists posted the genetic sequence of the coronavirus online. Researchers in Barouchs lab frantically began designing an Ad26 vaccine that would deliver part of the distinctive spike protein on the coronavirus into cells to trigger an immune response.

Two weeks later, Barouch contacted executives at Janssen to see if they were interested in collaborating with his lab, as they had on HIV, Zika, and Ebola. They were. Beth Israel soon signed an agreement with the company, which has licensed the technology from the hospital. A Beth Israel spokeswoman declined to share the terms of the deal.

Researchers worked marathon days at Barouchs lab designing multiple versions of the vaccine that were tested in mice, ferrets, hamsters, and rhesus monkeys. Outside, the streets of Boston were almost deserted because of the lockdown.

With Dans expert guidance, the teams were able to identify a COVID-19 vaccine candidate for clinical trials in just a few weeks, said Dr. Paul Stoffels, chief scientific officer for Johnson & Johnson.

The collaborators began testing it in an early-stage trial on about 1,000 volunteers during the summer. Updated results published Wednesday in the New England Journal of Medicine showed that the vaccine generated antibodies in the blood after one shot, but that two doses produced more.

But no one will know whether the vaccine prevents COVID-19 until results of the much bigger late-stage trial come in. Johnson & Johnson is also enrolling an estimated 30,000 volunteers for a second late-stage study that will examine whether two shots are more effective than one.

Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and an authority on vaccines, said he never thought the two mRNA vaccines would be the workhorses of a vaccination campaign on this vast scale, in part because of their cold-storage requirements. Hes more optimistic about the vaccine from Johnson & Johnson and a two-shot vaccine developed by AstraZeneca that uses a similar technology.

Barouch doesnt have time to bask in his new, if quiet, fame, but he is certainly aware of the many people counting on him, and his invention.

For one thing, they write to him. Although virologists dont typically get fan mail, Barouch said he has received more than 100 e-mails and letters from strangers who are rooting for him. One was from a woman in Ireland who read that Barouch plays violin with his daughters. She told him she loves all music, from Beethoven to Bruce, and offered a traditional Gaelic toast for good health.

My knowledge of science is a laywomans, but I am hopeful that you and all who work for and with you will succeed, wrote Ginny McNamara. So from Dublin, I will later raise a glass and say Slainte.

Jonathan Saltzman can be reached at jonathan.saltzman@globe.com.

Excerpt from:

Beth Israel researcher awaits approval of the COVID-19 vaccine he helped create - The Boston Globe