The US Food and Drug Administration will approve a vaccine expected to prevent or mitigate the severity of COVID-19 in at least 50% of people vaccinated.
“Everyone understands the urgent need for a vaccine, but one of the reasons we put out our guidance was to be clear about what data we needed to make sure we made the absolute best decision on behalf of the American people,” Hahn told CBS12 New.
“The bottom floor that we would want with terms of effectiveness is 50% effective,” Hahn said. “But of course, we’re hoping a vaccine would be even more effective than that.”
The FDA, which has released requirements to vaccine manufacturers entitled Development and Licensure of Vaccines to Prevent Covid-19, mandated that, in effect, the approved COVID-19 vaccines successfully protect at least half of the patients they’re given to.
The guidance also requires that manufacturers ensure the drug works on a wide variety of people, regardless of age, gender and race.
US President Donald Trump‘s administration has bought virtually all the stocks for the next three months of one of the two drugs proven to work against COVID-19.
Remdesivir, the first drug approved by the Food and Drug Administration to treat COVID-19, is made by Gilead Sciences and has been shown to help people recover faster from the virus. The first 140,000 doses, supplied to drug trials across the world, have been exhausted. Trump has now bought more than 500,000 doses, which is all of Gilead’s production for July and 90% of August and September.
“President Trump has struck an amazing deal to ensure Americans have access to the first authorised therapeutic for Covid-19,” said the US Health and Human Services secretary, Alex Azar. “To the extent possible, we want to ensure that any American patient who needs Remdesivir can get it. The Trump administration is doing everything in our power to learn more about life-saving therapeutics for COVID-19 and secure access to these options for the American people.”
New cases of COVID-19 rose by nearly 50,000, according to a Reuters tally, marking the biggest one-day spike since the start of the coronavirus pandemic. More than half of new cases each day come from the states of Arizona, California, Florida and Texas, home to 30% of the country’s population. Brazil, South America, is the only country to report more than 50,000 new cases in a day.
The World Health Organization has warned that the Middle East is at a “critical threshold”. There are more than one million confirmed cases of COVID-19 across the 22 countries, stretching from Morocco to Pakistan.
Over 80% of all deaths in the region were reported in Egypt, Iran, Iraq, Pakistan and Saudi Arabia.
“We are at a critical threshold in our region,” the WHO’s Middle East head, Ahmed al-Mandhari, said in an online press conference.
“The number of cases reported in June alone is higher than the total number of cases reported during the four months following the first reported case in the region on 29 January,” he said.
More than 10.6 million people around the world have been diagnosed with the coronavirus, over 5.6 million have recovered, and more than 515,000 people have died, according to Johns Hopkins University.