U.K. Lab to Sidestep Drug Industry to Sell Potential Virus Vaccine

By
NYtimes
-
0
113


LONDON — A prominent British laboratory is forming a special partnership that would sidestep the drug industry to sell a potential vaccine against the coronavirus without profits or licensing fees in Britain and in low- and middle-income countries.

Scientists, nonprofit groups and public health experts have urged that any successful vaccine to combat the pandemic be distributed at the lowest possible cost and on the basis of need rather than profit. But for-profit drug giants or biotechnology start-ups have dominated the development race, especially in the United States, a vital market because of its high drug prices.

The British laboratory, at Imperial College London, could alter that landscape, in part because its technology has the potential to develop a vaccine that is cheaper and easier to manufacture than others, said Robin Shattock, the lead scientist on the project.

If successful, he said, the vaccine’s lower cost could appeal to the large donor organizations that typically supply low-income countries, which make up much of the world. It could also provide a cheaper alternative in affluent countries.

“Somebody who’s developing a product that’s going to be of very high cost will actually ultimately lose out if the high-volume market doesn’t support that,” Professor Shattock said.

Clinical trials are beginning this month, and if the vaccine is proven safe and effective, the first doses could be available early next year.

To make the vaccine as widely and cheaply available as possible, Professor Shattock said, Imperial College is creating what it calls a “social enterprise” — a special-purpose, for-profit company chartered to sell the inoculation.

Imperial College is forming the company in partnership with the investment firm Morningside Ventures, which is based in Hong Kong. The new entity will be called VacEquity Global Health.

Morningside Ventures was founded by the Chan family, which is also a major donor to the T.H. Chan School of Public Health at Harvard.

Imperial College has promised that VacEquity Global Health will make its vaccine available at the lowest possible cost in Britain, as well as in low- and middle-income countries. VacEquity would work with specialized drug manufacturers, in a process similar to the production and sale of generic drugs.

The new company may charge higher prices in wealthier countries such as the United States, Singapore, or the Persian Gulf monarchies.

A clinical trial involving 300 participants in Britain — an unusual combined phase one and two — is set to begin on June 15. If that shows the drug to be safe, Imperial College will conduct a 6,000-participant phase in October to test the vaccine’s effectiveness. The location of the later phase will depend on where the virus is spreading rapidly at the time.

The Imperial College is using a novel technology that has never before produced a licensed vaccine. It is described as self-amplifying RNA and was pioneered by Professor Shattock over decades of research. The vaccine consists of specially engineered genetic material — RNA — that instructs muscle cells in the body to produce a distinctive “spike” protein found on the surface of the coronavirus.

If the vaccine is successful, those proteins will trigger an immune response that will kill the virus.

  • Updated June 5, 2020

    • How many people have lost their jobs due to coronavirus in the U.S.?

      The unemployment rate fell to 13.3 percent in May, the Labor Department said on June 5, an unexpected improvement in the nation’s job market as hiring rebounded faster than economists expected. Economists had forecast the unemployment rate to increase to as much as 20 percent, after it hit 14.7 percent in April, which was the highest since the government began keeping official statistics after World War II. But the unemployment rate dipped instead, with employers adding 2.5 million jobs, after more than 20 million jobs were lost in April.

    • Will protests set off a second viral wave of coronavirus?

      Mass protests against police brutality that have brought thousands of people onto the streets in cities across America are raising the specter of new coronavirus outbreaks, prompting political leaders, physicians and public health experts to warn that the crowds could cause a surge in cases. While many political leaders affirmed the right of protesters to express themselves, they urged the demonstrators to wear face masks and maintain social distancing, both to protect themselves and to prevent further community spread of the virus. Some infectious disease experts were reassured by the fact that the protests were held outdoors, saying the open air settings could mitigate the risk of transmission.

    • How do we start exercising again without hurting ourselves after months of lockdown?

      Exercise researchers and physicians have some blunt advice for those of us aiming to return to regular exercise now: Start slowly and then rev up your workouts, also slowly. American adults tended to be about 12 percent less active after the stay-at-home mandates began in March than they were in January. But there are steps you can take to ease your way back into regular exercise safely. First, “start at no more than 50 percent of the exercise you were doing before Covid,” says Dr. Monica Rho, the chief of musculoskeletal medicine at the Shirley Ryan AbilityLab in Chicago. Thread in some preparatory squats, too, she advises. “When you haven’t been exercising, you lose muscle mass.” Expect some muscle twinges after these preliminary, post-lockdown sessions, especially a day or two later. But sudden or increasing pain during exercise is a clarion call to stop and return home.

    • My state is reopening. Is it safe to go out?

      States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.

    • What’s the risk of catching coronavirus from a surface?

      Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.

    • What are the symptoms of coronavirus?

      Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.

    • How can I protect myself while flying?

      If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)

    • Should I wear a mask?

      The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.

    • What should I do if I feel sick?

      If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.

Moderna, a biotechnology company based in Cambridge, Mass., has started clinical trials for a vaccine using similar technology, known as messenger RNA. The U.S. government has agreed to provide as much as $483 million to Moderna to advance its research, and reports of positive results in the trial’s early stages have sent the company’s stock soaring.

Imperial College’s self-amplifying RNA vaccine, Professor Shattock said, would require a much smaller dose than the Moderna vaccine — 50 to 100 times smaller — which would greatly lower the cost per dose. The Imperial College vaccine would also require smaller and less costly manufacturing facilities than vaccines using other technologies, such as those involving the neutralized or modified versions of existing viruses, he said.

The British government has provided more than $50 million in financial support for the Imperial College effort, and it has also attracted $5 million from other donors.

The University of Oxford, which is beginning phase three clinical trials of an alternate potential vaccine, has tried a different approach to low-cost distribution. The university reached an unusual agreement with the British pharmaceutical giant AstraZeneca, which has pledged to distribute the potential vaccine at no profit for the duration of the pandemic.

AstraZeneca has already received hundreds of millions of dollars from the U.S. government, the British government and major nonprofit organizations to begin manufacturing as many as two billion doses of Oxford’s potential vaccine even before its effectiveness has been proven.

If demand persists after the pandemic has faded — perhaps persisting as a seasonal virus — AstraZeneca has said it may seek to profit from the sale of the vaccine.



Source : Nytimes

RELATED ARTICLESMORE FROM AUTHOR