The first large study of the safety and efficacy of a coronavirus vaccine in the United States began Monday morning, according to the National Institutes of Health and the modern biotech company, which collaborated to develop the vaccine.
A volunteer in Savannah, Georgia received the first injection at 6:45 am, said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, at a press conference.
The study, a phase 3 clinical trial, will enroll 30,000 healthy people at approximately 89 sites across the country this summer. Half will receive two injections of the vaccine, 28 days apart, and the other half will receive two injections of a salt water placebo. Neither the volunteers nor the medical personnel administering the injections will know who will receive the actual vaccine.
The researchers will then monitor the subjects for side effects. And its main goal will be to see if a significantly smaller number of vaccinated people get Covid-19, to determine if the vaccine can prevent the disease. The study will also try to find out if the vaccine can prevent severe cases of Covid and death; if you can block the infection completely, based on laboratory tests; and if only one injection can prevent the disease.
A second company, Pfizer, announced Monday afternoon that it had also begun a late-stage study of a coronavirus vaccine. Pfizer has been working with a German company, BioNTech. Their study will also include 30,000 people, from 39 states in the United States, and from Brazil, Argentina, and Germany.
The first subjects received injections at the University of Rochester on Monday.
The government announced last week that it had reached a $ 1.95 billion deal to buy 100 million doses of the Pfizer vaccine by the end of the year, but only if the trial shows that it is safe and effective.
Dr. Fauci estimated that the full enrollment of 30,000 people in the Moderna trial would be completed in late summer, and that the results may be available by November. The findings could emerge even sooner, he said, but added that he doubted it. He said high transmission rates in some parts of the country, while unfortunate, would help speed up the process of determining if the vaccine works.
Dr. Mark Mulligan, director of NYU’s Langone Vaccine Center in New York, which will begin administering injections of the Pfizer vaccine on Tuesday, said he thought full enrollment would take two months, and that it would take four to six months. determine if the vaccine worked.
Overall, a total of 150 to 160 coronavirus infections in the study will be enough to determine if the Modern vaccine is acceptably effective, that is, if it protects 60 percent of those who receive it, Dr. Fauci said.
Ideally, he would like the number to be higher, but said 60 percent “would be a great step to control this outbreak; we will take that amount.”
Dr. Francis Collins, director of the National Institutes of Health, said the US government was reaching out to the groups most affected by Covid: older people, people with chronic illnesses, blacks, Latinos, and Native Americans, to encourage them to participate in studying. He said the pandemic had put health disparities into “acute relief” and that additional efforts were needed to gain the trust of people in those groups who might be reluctant to enroll in a medical experiment.
Previous tests of the Moderna vaccine showed that it stimulated a strong immune response, with minor and transient side effects such as arm pain, fatigue, pain, and fever. But exactly what kind of immune response is needed to prevent the disease is not known, so Phase 3 studies are essential to determine if a vaccine really works.
The coronavirus outbreak>
Frequent questions
Updated July 27, 2020
-
Should I refinance my mortgage?
- It could be a good idea, because mortgage rates have never been lower. Refinancing applications have taken mortgage applications to some of the highest levels since 2008, so be ready to get online. But the defaults have increased, too, so if you’re thinking about buying a home, be aware that some lenders have tightened your standards.
-
What will school be like in September?
- Many schools are unlikely to return to normal hours this fall, requiring the routine of online learning, impromptu child care, and delayed work days to continue. California’s two largest public school districts, Los Angeles and San Diego, said July 13 that instruction will be remote only in the fall, citing concerns that rising coronavirus infections in their areas pose too serious a risk to students and teachers. Together, the two districts enroll about 825,000 students. They are the largest in the country so far to abandon plans for a partial physical return to classrooms when they reopen in August. For other districts, the solution will not be an all-or-nothing approach. Many systems, including the country’s largest New York City, are developing hybrid plans that involve spending a few days in classrooms and other days online. There is no national policy on this yet, so check with your municipal school system regularly to see what’s going on in your community.
-
Is the coronavirus in the air?
- Coronavirus can remain in the air for hours in tiny droplets in stagnant air, infecting people as they inhale, growing scientific evidence suggests. This risk is highest in crowded interior spaces with poor ventilation, and may help explain overcast events reported in meat packing plants, churches, and restaurants. It is unclear how often the virus is transmitted through these tiny droplets or sprays, compared to larger droplets that are expelled when a sick person coughs or sneezes, or is transmitted through contact with contaminated surfaces, Linsey said. Marr, Virginia Tech aerosol expert. Aerosols are released even when a symptom-free person exhales, speaks or sings, according to Dr. Marr and more than 200 other experts, who have summarized the evidence in an open letter to the World Organization. Of the health.
-
What are the symptoms of coronavirus?
-
Does Covid-19 transmit asymptomatic?
- So far, the evidence seems to show that it does. A widely cited article published in April suggests that people are most infectious approximately two days before the onset of coronavirus symptoms, and estimated that 44 percent of new infections were the result of transmission from people who still had no symptoms. Recently, a senior expert from the World Health Organization stated that transmission of the coronavirus by people without symptoms was “very rare,” but later withdrew that claim.
In a statement, Dr. Collins said: “Having a safe and effective vaccine distributed by the end of 2020 is a difficult goal, but it is the right goal for the American people.” He said that despite the unprecedented speed to bring this experimental vaccine to human testing, “the strictest safety measures were maintained.”
Moderna said in a statement that it could deliver approximately 500 million doses a year, and possibly up to a billion doses per year, as of 2021. The Massachusetts-based company, which has received nearly $ 1 billion from the federal government to Developing a coronavirus vaccine, he has said he will not sell the vaccine at cost, but for profit.
Moderna has not said what it will charge. “We will assign it a responsible price during the pandemic, to make sure it is widely accessible,” a spokesman, Ray Jordan, said in an email. The company may change the price later, when the virus becomes endemic, “but that is not something we have solved at the moment,” Jordan said.
Moderna’s shares rose more than 9 percent on Monday.
Pfizer has also said it would sell its product at a profit; the government contract is about $ 20 per injection, and people will need two.
Both the Moderna and Pfizer / BioNTech vaccines use a synthetic version of genetic material from the coronavirus, encased in tiny particles made of fat that help it enter human cells. The genetic material, called messenger RNA or mRNA, prompts cells to make a small part of the virus, which the immune system sees as foreign and learns to recognize. If the person is later exposed to the real virus, the immune system will attack it.
Messenger RNA has yet to produce any approved vaccines, but other companies have also invested in the approach, due to its potential to rapidly produce vaccines. CureVac and Sanofi are also working on mRNA vaccines.
At the press conference, Dr. Collins said another three Phase 3 trials would soon begin, each of which would require 30,000 patients. Those trials will include vaccines made by Novavax, Johnson & Johnson and a collaboration of the University of Oxford and AstraZeneca. All three companies are part of the Trump administration’s Operation Warp Speed. Pfizer is not.
Adults interested in participating in the trials can visit coronaviruspreventionnetwork.org.
