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The World Health Organization remains “intimately” involved in global efforts to develop a vaccine against the novel coronavirus virus, according to a top federal government vaccine official.
“Right now the World Health Organization remains intimately involved working with a number of groups, working with an international vaccine group, working with GAVI for procurement of vaccine,” Dr. John Mascola, the director of the Vaccine Research Center at National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, said Friday.
Mascola added: “In the pool we swim in our level and those interactions with WHO, scientific interactions and public health interactions, are going as usual and it’s going to be absolutely critical for the US effort to be linked and coordinated with the international effort, too, with WHO."
Last month: President Trump said he was terminating the US’ relationship with WHO, withholding billions of dollars in support and launching an investigation into the global health agency’s response to the coronavirus pandemic.
Minority communities in the United States have been the most severely impacted by the coronavirus pandemic, but questions remain about whether they will have the greatest access to a potential vaccine, two vaccine experts said Friday.
Another question: whether minorities trust the government enough to participate in the crucial trials needed to develop a vaccine, Dr. John Mascola, the director of the NIH’s National Institute of Allergy and Infectious Disease, said Friday at a town hall on Covid-19 vaccines.
“As we think about how to test the vaccines and find out if they work … the question is can we make enough so that we can make it available to large parts of the population, and can it be accessible and can it be affordable,” Mascola said.
Some context: When the US government is involved, as it is with the development of a coronavirus vaccine, there are a number of agencies that will make decisions during the development process. For example, the US Centers for Disease Control and Prevention will make the recommendations on who gets it, Mascola said.
“But there are built in provisions already that when the US government is involved in a substantial part of the funding for the effort, as it is here that in the United States, that vaccine will be available to the US government for distribution,” he said.
Since the government is helping fund the development of a coronavirus vaccine, that should help make it affordable, Mascola said.
But before that can even happen, clinical trials involving thousands of people are needed to help decide if a vaccine candidate is effective.
“We are working with HHS and predictive analytics to be able to track where the virus is to match that with where we do the vaccination campaigns, and also to make sure that we enroll the populations that are at highest risk,” said Dr. Larry Corey, a leading expert in virology, immunology and vaccine development and a member of the Fred Hutchinson Cancer Research Center’s vaccine and infectious disease division.
As national protests over police brutality and the US judicial system continue into a second week, vaccine developers may have a harder time convincing people of color to participate in the trials. “And frankly, this is one of the new worries,” Corey told the town hall.
“Our underserved populations are Black and Hispanic populations. We are going in as a US government organization and whether events these last couple of few weeks are going to affect our ability to establish medical trust through the kinds of things that we need to do with community outreach, that becomes really a central issue for us to be able to enroll the people who have been most affected by Covid-19,” he said.
“It is showing the health disparities in our country,” Corey said.
The largest shopping mall in the US is set to reopen next week.
The Mall of America – which is located in Bloomington, Minnesota – will open on June 10 for the first time since March. The mall’s website says the facility initially will have a limited number of stores open, and some will offer curbside pickup.
The Mall of America originally was scheduled to reopen on June 1, but that was pushed back in the wake of protests and violence following the killing of George Floyd in nearby Minneapolis.
The city of Miami Beach announced in a news release Friday that certain businesses may reopen starting Monday June 8.
Those businesses include gyms, fitness studios, tattoo parlors, massage studios and summer camps if they meet the guidelines for reopening, according to the release.
Movie theaters, concert houses, auditoriums, playhouses and bowling alleys may be permitted to reopen if they submit a Covid-19 mitigation plan to the city and county and it is approved, the release said.
Bars, pubs and nightclubs that are licensed by the state can reopen if they sell food, the release said.
Legal short-term rentals that have licenses from the city can reopen today, per the emergency order guidelines, the release said.
The emergency order in the city was extended to June 12, according to the release.
Infectious disease experts from the National Institutes of Health and the Fred Hutchinson Cancer Research Center said the chances of developing a successful Covid-19 vaccine by January is an extremely ambitious challenge, but it’s possible.
“Everything will have to go incredibly perfectly if that's going to happen,” said Dr. Larry Corey, a leading expert in virology, immunology and vaccine development and a member of Fred Hutch’s vaccine and infectious disease division. “Obviously the first vaccine out of the box, which is this RNA vaccine, whether it's Pfizer or Moderna, are going to have to work terrifically well to get an answer by January."
“The higher the efficacy or the better the efficacy, the shorter the time is needed to show that a vaccine actually shows an effect as the number of cases occur are much fewer in the vaccine group than they are in the placebo group. So, could that potentially happen by January? Yes, it could potentially happen by January,” Corey added.
Vaccine trials are now underway and Corey said they will require the cooperation and collaboration of the pharmaceutical industry, academia, research centers, the biotech industry and the NIH.
The only thing that matters at the end of the day is the vaccine data, said Dr. John Mascola, the director of the Vaccine Research Center at NIH’s National Institute of Allergy and Infectious Disease, who was also part of the town hall.
“All the vaccine scientists in the world, political scientists in the world can make predictions or be encouraged by the data, but the only data that matters at the end of the day is if we do a placebo-controlled study and can confidently say the vaccine works, it reduces the risk that somebody gets severe Covid,” Mascola said.
New York City's Metropolitan Transportation Authority Chairman and CEO Patrick Foye announced a 13-point action plan ahead of the start of New York’s phased reopening Monday.
The 13 points include increasing the presence of New York Police Department and MTA police officers systemwide, staggering hours for MTA employees, using contactless payment systems and having floor markings for social distancing he said.
Foye also urged businesses to stagger hours for their own employees in order to avoid overwhelming the system during rush hour.
Here's a look at all 13 points:
As the United States continues to reopen, inaccurate diagnostic tests may undermine the country's ability to keep the Covid-19 pandemic from spreading, experts on health policy argued Friday in the New England Journal of Medicine.
Some antibody tests, the tests that can identify if someone had a prior infection, have come under criticism from the US Centers for Disease Control and Prevention and the US Food and Drug Administration for being inaccurate, but the diagnostic tests used in this pandemic have also had their share of problems, the experts argued.
Someone who has a false positive on a coronavirus test may quarantine unnecessarily and resources would be wasted on unnecessary contact tracing. A false negative diagnostic test may be an even bigger problem, since it might mean that someone who is asymptomatic doesn’t stay home and will continue to spread the disease, argued Dr. Steven Woloshin of the Center for Medicine in the Media at the Dartmouth Institute for Health Policy and Clinical Practice, Dr. Aaron S. Kesselheim, who founded the Harvard Program on Regulation, Therapeutics, and Law and colleagues.
The tests can be inaccurate by either giving a false positive result or a false negative. One study that hasn’t been peer reviewed yet in patients in China found false negatives ranging between 2 to 29%. Another found that 40% of throat samples taken from hospitalized patients in the study in China were false negatives.
The sensitivity rates of these tests used in these studies was about 70%. Sensitivity is the ability to correctly identify who is infected. At this level, with a pretest probability of 50%, the post-test probability with a negative test would be 23% - and that’s “far too high to safely assume someone is uninfected,” they wrote.
Call for action: The authors urge the FDA and clinical researchers to review the accuracy of the tests currently on the market. They also want manufacturers to provide details about how they proved the test sensitivity was accurate.
Measuring test sensitivity in asymptomatic people should be an “urgent priority” and, they say, doctors should keep in mind that negative results even on tests that are considered highly sensitive cannot rule out infection if the pretest probability is high. So doctors should not trust negative results if they don’t match up with the symptoms they are seeing in patients.
If the tests were perfect, a positive test would mean someone carries the virus and a negative test would mean that they don’t. Yet with imperfect tests, we can only assume that a person is “less likely to be infected,” the authors argue - and that’s not enough to help keep the pandemic from spreading further.
Minnesota Gov. Tim Walz announced the reopening of indoor dining, gyms and entertainment venues beginning Wednesday as part of the state's phase three of reopening.
Occupancy will be limited based on risk, with an overall occupancy maximum of 250 people, the statement said.
“Thank you, Minnesotans, for the sacrifices you’ve made to slow the spread of Covid-19,” Gov. Walz said in a statement. “Thanks to your dedication, we are now in a position to carefully turn the dial toward reopening society. As we move forward, it is more important than ever that we each do our part as we trust and rely on each other to keep our state safe.”
Here are the guidelines for phase three:
- Restaurants can begin offering indoor dining while maintaining social distancing, requiring reservations and seating no more than 50% occupancy.
- Indoor social gatherings can take place with 10 people or fewer.
- Outdoor social gatherings can take place with 25 people or fewer.
- Gyms, personal fitness and yoga studios and martial arts may open at 25% capacity
- Indoor entertainment venues, such as theaters and concert halls, can open at 25% capacity.
- Recreational indoor entertainment venues, such as bowling alleys, arcades, and museums may open at 25% capacity.
- Personal services, such as salons, tattoo parlors, and barbershops, may increase occupancy rates to 50% while requiring reservations.
- Outdoor entertainment venues, such as sporting events, concerts and theaters may open at 25% capacity.
- Places of worship can increase occupancy rates to 50%.
Fears protests could cause surge in Covid-19 cases: This reopening announcement comes as the the state deals with ongoing protests following the death of George Floyd in Minneapolis.
State officials have expressed fear that coronavirus could spread rapidly during these demonstrations, with Gov. Walz saying on May 30 that he is "deeply concerned about a super-spreader type of incident" and that a spike in Covid-19 cases is "inevitable."