A version of this story appeared in the August 31 edition of CNN's Coronavirus: Fact vs. Fiction newsletter. Sign up here to receive the need-to-know headlines every weekday.
The agency's boss Dr. Stephen Hahn told the Financial Times that it's up to the vaccine developer to apply for authorisation or approval. "If they do that before the end of Phase Three, we may find that appropriate. We may find that inappropriate, we will make a determination," Hahn told the newspaper.
At the moment, an OK from the FDA is what's needed to put a vaccine on the market. However, several prominent physicians and experts are calling for the creation of an independent commission to review data from coronavirus vaccine trials before a vaccine is allowed on the market.
The physicians cite public distrust of vaccines and criticism of government agencies during the pandemic. They say that while they trust the US scientific and ethical rigor, they think many Americans will be skeptical of the findings of an FDA committee, especially since some of its members work for pharmaceutical companies and government agencies, according to the roster currently on the FDA website. Adding a layer of independent review may reassure Americans that the shot is safe and effective.
A CNN poll this month showed that 40% of Americans do not want to get a coronavirus vaccine when it becomes available, even if it's free and easy to access. Such a low uptake of the vaccine could hinder the ability to get the virus under control and return to normalcy.
The willingness of Americans to get a shot may be hurt further by the fact that people will likely need two doses, rather than just one. There are also potential logistical issues. America's poor record of distributing protective equipment and test kits shows that medical supply chains are far from efficient. Manufacturing and distributing double the amount of vaccines, vials and syringes will be a tall order.
YOU ASKED. WE ANSWERED
Q: If a pregnant woman gets Covid-19, will her baby be infected? And can babies get coronavirus through breastfeeding?
A: About 2% to 5% of babies born to mothers with Covid-19 tested positive for coronavirus within the first four days of life, according to the American Academy of Pediatrics.
But infected mothers are unlikely to pass coronavirus to their newborns when appropriate precautions are taken. A study published in The Lancet Child & Adolescent Health found no cases of viral transmission among 120 babies born to 116 mothers with coronavirus — even when both shared a room and the mothers breastfed.
But the babies remained 6 feet apart from their mothers, except while breastfeeding. The moms also wore surgical masks when handling their newborns and followed proper hand and breast washing procedures.
Send your questions here. Are you a health care worker fighting Covid-19? Message us on WhatsApp about the challenges you're facing: +1 347-322-0415.
WHAT'S IMPORTANT TODAY
India becomes the world's third deadliest Covid-19 country
India reported 971 Covid-19 deaths yesterday, bringing the total to 64,469 and surpassing Mexico as the country with the third highest number of Covid-19 deaths globally, according to the latest data released by the countries' health ministries and Johns Hopkins University.
The country of 1.3 billion saw 78,512 new Covid-19 infections yesterday, the fifth consecutive day of more than 75,000 daily new cases. Despite the high numbers, the union territory, which includes Delhi, prepares to resume metro rail services, which cater to an estimated 1.5 million people per day.
More than 25 million people have now been infected around the world. The US leads the grim tally, with its case count fast approaching 6 million. Brazil and India have both reported well over 3.5 million cases. Russia looks set to become the fourth country to reach 1 million cases later this week.
With borders shut, Americans are trapped in their own healthcare system
Pandemic travel restrictions have made Americans prisoners of their country. Even within North America, Mexico and Canada have closed thousands of miles of border to all but essential travel, roiling plans for vacation, work, and school. For cash-strapped Americans, it has also cut off access to medicines and healthcare services that they can't afford at home -- at a time when money is tighter than ever.
Stephanie Boland's nine-year-old son was diagnosed with diabetes in December. Traveling to Canada to fill his insulin prescription took a half-day's drive from where they live in Brainerd, Minnesota, but it was worth it -- the purchase was a simple, over-the-counter affair. One pack of injection pens, which would last several months, cost less than a hundred dollars, she says, compared to a list price of $530 at home.
As their son's disease began to rewrite the routines of daily life, the Bolands planned to cross into Canada again to restock. Then the pandemic hit. Caitlin Hu reports on the dwindling options of Americans who can't afford to be sick in the United States.
Is the $5, five minutes coronavirus test any good?
The FDA granted emergency use authorization to another antigen test last week, bringing the total to four. Compared to the most commonly used type of coronavirus test -- molecular diagnostic tests, also called PCR tests -- these antigen tests don't need complicated chemicals, viral transport media or RNA extraction kits. They don't require highly specialized technicians and labs and thus can provide a result in minutes, rather than hours or days. They are also much, much cheaper.
"The PCR molecular tests actually test for the virus' genetic material and the antigen test is testing for one of the viral proteins, so a piece of the virus," said Dr. Jonathan Quick, managing director for pandemic response, preparedness and prevention at the Rockefeller Foundation. The downside? They are not as sensitive and therefore less reliable than the traditional PCR tests. Quick said the PCR test will always have a role as a highly accurate diagnostic test, but the antigen test will be used as a screening test for asymptomatic people.
Europe's fight against Covid-19 shifts from hospitals to the streets
In the last week, several European countries have seen record infection rates. Not since the spring have countries like France, Germany, Italy and Spain seen such a surge in the number of new cases. Even nations like Greece and Croatia, largely spared by the first wave, have seen fast rises in August.
With authorities determined to avoid a second wave of lockdowns, legislation has been introduced to try and stop the spread of the virus. Nightclubs have been closed in Italy and in Greece, curfews introduced in Spain, Italy and Greece and facemasks made mandatory in an ever-growing number of public, outdoor spaces, in most EU countries: a gradual tightening of regulations that will now have to be enforced. The fight against Covid-19 has become a matter of law and order, Melissa Bell reports.
A growing pushback from Europeans is putting a further strain on police resources. Berlin police was forced to halt a protest against the regulations on Saturday, citing the 20,000-strong crowd's failure to abide by social distancing guidelines. In London, a large crowd of protesters gathered in Trafalgar Square to demonstrate against the UK's government's coronavirus measures, with video and still photos of the event indicating the attendance was in the thousands.
Once again, there's one rule for elites and another for everyone else
EU Commissioner Phil Hogan, who resigned from his post last week for breaking Ireland's coronavirus restrictions by attending a political golf society event with 80 other people, was just the latest member of the political elites to be caught flouting the rules. On the other side of the world, New Zealand's health minister, David Clark, was forced to resign last month after missteps including breaking the country's stay-at-home order to take his family to the beach. And in the US, social distancing appears to have been largely disregarded at Republican National Convention events last week.
Such examples have a lasting impact on the public's willingness to abide by restrictions, Laura Smith-Spark writes. Susan Michie, a professor of health psychology at University College London and a member of a behavioral advisory group for the UK government's Scientific Advisory Group for Emergencies said data shows that trust and adherence to lockdown rules dropped significantly in the UK after Prime Minister Boris Johnson's chief adviser, Dominic Cummings, drove the length of England with his wife and child during lockdown, while his wife was sick with suspected coronavirus. "Trust is very difficult to build up again -- it's easy to lose, difficult to build up," Michie said.
ON OUR RADAR
- An unidentified US Open player won't compete in the event that starts today after testing positive for the coronavirus, the United States Tennis Association said Sunday.
- US colleges and universities are struggling to contain outbreaks of Covid-19 and enforce policies meant to prevent its spread: 36 US states have reported a total of 8,700 cases at colleges and universities.
- Temporary drinking restrictions are back in vogue worldwide, thanks to coronavirus.
- Colorado Girl Scout troop uses cookie money to make PPE for elementary school during the pandemic.
- Companies that aim to make home a bit cozier, or a bit more functional, are benefiting from Americans having nothing better to do -- and few other places to go.
- Lionel Messi failed to show up for a coronavirus test at Barcelona's training ground on Sunday, club sources have confirmed to CNN, casting further doubt on his future at the La Liga powerhouse.
- Unable to open its concert hall, the New York Philharmonic brings its music to the streets.
- Professional cake decorator helped a couple DIY their dream wedding cake after Covid-19 forced them to cancel their plans.
- The real winner of the MTV Video Music Awards? Lady Gaga's masks.
Planet-friendly activities that are good for your body and pandemic possible
What's the perfect pandemic hobby? As people across the globe have adjusted their lives to Covid-19, activities as varied as bread baking and gaming have trended.
But while carbs and screen time can bring a satisfying rush of endorphins, the ideal Covid pastime should offer more sustaining thrills.
Here's a whole list of activities good for your body, mind and the planet.
TODAY'S PODCAST
"When you walked those floors in April, a total quiet, everybody either on a vent or in ICU ... and you walk down the hall and you know a good percent of these people probably won't make it. That was our reality." -- Michael Dowling, Northwell Health CEO
Northwell Health in New York has treated more Covid-19 patients than any other hospital system in the country. CNN's Chief Medical Correspondent Dr. Sanjay Gupta talks to Northwell CEO Michael Dowling about the important lessons his team learned throughout the crisis. His new book is called "Leading Through a Pandemic". Listen Now.
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