The resurgence of cases that affects more than half of U.S. states and territories fueled concerns among health experts on Tuesday, as new diagnoses continue to rise within U.S. borders.
With infections increasing in the Sun Belt states, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told a Senate committee Tuesday that he is very concerned about the growing trend in cases.
“I wouldn’t be surprised if we go up to 100,000 a day if this doesn’t change,” Fauci warned.
To date, the highest single-day case count in the US was over 47,000 on June 26. According to Fauci, the country is adding 40,000 cases a day on average, double the previous average of 20,000 cases a day in the U.S.
However, the director of the Centers for Disease Control (CDC), Robert Redfield, recently said that the case count in the US is probably ten times more than what has been reported. On Tuesday, he told lawmakers that up to 8% of the US population has likely experienced the virus.
The United States continues to be a global epicenter of the pandemic, with more than 2.6 million reported cases and more than 126,000 deaths. The global count continues to have increased 10.3 million and more than 506,000 have died; However, the data shows that at least half of all infected have recovered.
Reflecting its status as a COVID-19 access point, the European Union reopened its borders to international travel on Tuesday, but the world’s largest economy is not on the list, unlike Canada, which has also maintained its closed borders to the US
Meanwhile, New York, New Jersey and Connecticut expanded the list of states where travelers must self-quarantine for at least 14 days if they travel to the three-state area.
FDA vaccine guidelines
A volunteer receives an injection from a medical worker during the country’s first human clinical trial for a potential vaccine against the new coronavirus, at the Baragwanath hospital in Soweto, South Africa, June 24, 2020. REUTERS / Siphiwe Sibeko TPX IMAGES OF THE DAY
In his comments, Fauci also reiterated his cautious optimism about a possible coronavirus vaccine, with a group of key pharmaceutical firms spearheading the effort.
The FDA released a 24-page guidance document Tuesday outlining the safety measures that pharmaceutical companies must take to receive emergency use authorization and eventual approval of any COVID-19 vaccine.
Despite the urgency and ambitious floating calendars, Commissioner Stephen Hahn reiterated Tuesday that the regulatory body will not be cutting corners to approve a vaccine
The agency’s guide noted that “immune responses to vaccines that could predict protection against COVID-19 are currently limited and evolving.” The FDA does not anticipate a high efficacy rate, but has said that at least 50% would be acceptable.
However, companies involved in the vaccine race, such as Johnson & Johnson (JNJ), are setting a relatively high standard for their experimental candidates. A senior JNJ executive told Yahoo Finance earlier this month that he points to a success rate in at least 70% of his clinical trials.
And while the FDA required testing of the vaccine in older and higher-risk individuals, it encouraged “the inclusion of diverse populations in all phases of the vaccine’s clinical development.” This inclusion helps ensure that vaccines are safe and effective for everyone in the right populations. “
The FDA also addressed a much-debated strategy of intentionally infecting individuals for trial in case decline, making it more difficult to assess the effectiveness of a vaccine.
“If it is no longer possible to demonstrate the effectiveness of the vaccine by conducting clinical studies of disease endpoint efficacy, the use of a controlled human infection model can be considered to obtain evidence to support the efficacy of the vaccine.” the FDA said.
However, the agency said that many issues “including logistics, protection of human subjects, ethical and scientific issues, would have to be satisfactorily addressed.”
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