$1.2 Billion From U.S. to Drugmaker to Pursue Coronavirus Vaccine

This post was originally published on this site

Expanding its pursuit of an inoculation against the coronavirus, the U.S. Department of Health and Human Services said on Thursday it would provide “up to $1.2 billion” to the drug company AstraZeneca to develop a potential vaccine from a laboratory at Oxford University.

The deal with AstraZeneca is the fourth and by far the largest vaccine research agreement that the department has disclosed. The money will pay for a Phase 3 clinical trial of a potential vaccine in the United States this summer with about 30,000 volunteers.

The H.H.S. statement said the agency and AstraZeneca “are collaborating to make available at least 300 million doses,” and projected that the first doses could be available as early as October.

That is a very accelerated, ambitious timetable. Most public health experts and scientists caution that a viable, mass-produced vaccine would probably not be available until sometime next year, at the earliest. Plus, billions of doses would be needed around the world.

There is no proven treatment or vaccine against the virus, and infectious-disease experts also warn that many vaccine candidates take years to perfect. Some fail or cause such severe side effects that human trials are halted.

But even before any are approved, governments and other organizations like the Bill & Melinda Gates Foundation are spending millions of dollars to prepare for the manufacturing of several potential vaccines to make them broadly available as soon as possible.

In a separate statement, AstraZeneca said it had reached agreements with several governments and other organizations to produce at least 400 million doses, had “secured manufacturing capacity for one billion doses,” and will begin its first deliveries in September.

AstraZeneca said it was also discussing deals for simultaneous production by other companies, including the giant Serum Institute of India, a major supplier of vaccines to the developing world.

The Biomedical Advanced Research and Development Authority at H.H.S. is distributing billions of dollars to companies to develop vaccines, including the latest funding to AstraZeneca. The authority, known as Barda, has already agreed to provide up to $483 million to the biotech company Moderna and $500 million to Johnson & Johnson for their separate vaccine efforts. It has also agreed to provide $30 million to a coronavirus vaccine effort by the French company Sanofi, building on a larger contract announced last December for making flu inoculations.

Scores of vaccine efforts are underway around the world, and several potential vaccines are now in at least small-scale clinical trials. But the Oxford vaccine candidate, now licensed by AstraZeneca, has moved quickly into the kind of large-scale testing necessary to prove safety and effectiveness.

Building on efforts to develop a vaccine against a similar disease, the Middle East Respiratory Syndrome, the Oxford scientists last month began a Phase I trial of their potential vaccine against Covid-19 in Britain involving 1,100 participants. A combined Phase II and Phase III trial involving 5,000 participants is set to begin in Britain by the end of this month.

The researchers have said that if the vaccine is proven effective, they hope to have an approval for emergency use, worldwide, by September. But a steep decline in the rate of new infections in Britain may make it difficult to prove effectiveness. Ethics rules generally preclude deliberately infecting test participants. That means unless enough test participants who are given a placebo become infected with the virus in the community, the researchers cannot show that the potential vaccine does its job.

The large-scale tests in the United States this summer may provide another opportunity.

On Monday, Moderna announced partial data of its first-phase trial, saying its vaccine candidate had proven safe and that it had provoked an immune response in 8 of 45 people. It is also working on an accelerated timetable with partners at the National Institute of Allergy and Infectious Diseases and the Swiss company Lonza. Moderna received approval to move to a second phase involving 600 people and said it would also begin a third stage in July with thousands of healthy people.

  • Frequently Asked Questions and Advice

    Updated May 20, 2020

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

      Over 38 million people have filed for unemployment since March. One in five who were working in February reported losing a job or being furloughed in March or the beginning of April, data from a Federal Reserve survey released on May 14 showed, and that pain was highly concentrated among low earners. Fully 39 percent of former workers living in a household earning $40,000 or less lost work, compared with 13 percent in those making more than $100,000, a Fed official said.

    • 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.)

    • Is ‘Covid toe’ a symptom of the disease?

      There is an uptick in people reporting symptoms of chilblains, which are painful red or purple lesions that typically appear in the winter on fingers or toes. The lesions are emerging as yet another symptom of infection with the new coronavirus. Chilblains are caused by inflammation in small blood vessels in reaction to cold or damp conditions, but they are usually common in the coldest winter months. Federal health officials do not include toe lesions in the list of coronavirus symptoms, but some dermatologists are pushing for a change, saying so-called Covid toe should be sufficient grounds for testing.

    • 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.

    • How can I help?

      Charity Navigator, which evaluates charities using a numbers-based system, has a running list of nonprofits working in communities affected by the outbreak. You can give blood through the American Red Cross, and World Central Kitchen has stepped in to distribute meals in major cities.

The Trump administration’s efforts to stanch the pandemic have been troubled by a series of agency fumbles, starting with defective C.D.C. tests that stalled detection of the virus’s spread for weeks and limited diagnoses for patients at hospitals and clinics.

Recently, President Trump reorganized vaccine and treatment efforts after he dismissed last month the head of Barda, Rick Bright, who then filed a whistle-blower complaint contending he had been pressured to seek approval for certain treatments for Covid-19. Just last week, Mr. Trump named Moncef Slaoui, a venture capitalist who was a longtime vaccine executive at GlaxoSmithKline and most recently a board member for Moderna, to help oversee “Operation Warp Speed,” the federal drive to accelerate ways to combat the virus.

As lead scientist of the effort, Dr. Slaoui’s myriad financial and drug company ties have come under scrutiny from watchdog groups. He is working as a contract employee and therefore exempt from conflict-of-interest and disclosure rules that pertain to many executive and federal employees. He did sell his stock in Moderna and donated some of his gains to cancer research, he said in an interview this week.

On Thursday, as Mr. Trump traveled to Michigan, he was asked about the $1 billion grant to AstraZeneca. While saying he was encouraged by recent vaccine developments, he also suggested — as he had earlier — that there would be “big, big announcements” within the next few weeks or so about treatment or therapeutic developments. But he offered no specifics.