Pfizer-BioNTech vaccine could be ready for approval by mid-October -- but there are still 'unknowns'

Pfizer Inc. signage is seen on July 22 in New York City. Jeenah Moon/Getty Images

Pfizer and BioNTech are confident they can have a vaccine against the novel coronavirus ready for regulatory approval by the middle of October, BioNTech CEO and co-founder Ugur Sahin has told CNN.

"It has an excellent profile and I consider this vaccine ... near perfect, and which has a near perfect profile," Sahin said in an exclusive interview with CNN.

He added that the company's "understanding of the mode of action, in combination with the safety data coming in from the running trial" meant that they have "a lot of confidence" in it.

"Yes, we believe that we have a safe product and we believe that we will be able to show efficacy,” he said.

Sahin told CNN he believes that approval for emergency use will be granted quickly by regulatory authorities.

US drug giant Pfizer and German firm BioNTech say they plan to provide 100 million doses of their vaccine candidate, BNT162, by the end of the year, and up to 1.3 billion doses in 2021.

Watch:

As Spain struggles to reign in the fastest growing Covid-19 infection rate in Europe, it's grappling with how to ensure safety in classrooms this September, even as some schools in Madrid have been forced to delay the start of school by several days or even weeks.

Spain became the first country in western Europe to reach half a million confirmed coronavirus infections on Monday, and recorded its highest daily case count since May on Friday.

In order to stop the spread in schools, the country's government laid down the rules at the end of August: All students aged six and above must wear masks in class; class sizes are to be reduced; students are to be kept in assigned "bubbles" to prevent them mixing; desks must be positioned at least 1.5 meters apart; all schools must improve open-air ventilation, and provide hand disinfection stations.

The new Covid-19 regulations, however, risk widening the gap between rich and poor, by exacerbating the disparity between private and public schools -- especially in the hardest-hit neighborhoods of Madrid.

Read the full story here

Getting a flu shot is a safe, inexpensive way to stay healthy.

But in a typical year, less than half of Americans get the vaccination (just 45% last year). Rates in the United Kingdom are comparable, where just 44.9% of registered patients ages 6 months to 64 years old got a flu vaccination from 2018 to 2019. In the European Union, which committed in 2009 to vaccinate at least 75% of residents ages 65 and older, only 45% of people in that group received vaccines in 2018. 

The number is even lower for people of color, who have been especially vulnerable during the pandemic. In the 2017 to 2018 flu season, just 28.4% of Hispanic people in the United States got vaccinations against influenza. 

With the Covid-19 pandemic spreading rapidly around the globe, distributing the flu vaccine takes on new urgency, according to medical experts. 

It's not just to free up resources for Covid-19 patients, though. 

"Influenza is a deadly disease in its own right," Bailey said.

And because flu symptoms -- including fever, sore throat and cough --  look so similar to Covid-19 symptoms, it will be impossible to rule out a coronavirus diagnosis without a test. That means a case of the flu, even if it turns out to be mild, can cause substantial disruption to work and school.

Read the full story:

People sit on benches facing the ferris wheel in Ocean City, New Jersey on September 7. Alexi Rosenfeld/Getty Images

Ahead of Labor Day this year, health officials warned that how Americans chose to ring in the unofficial start of fall could shape what the next months in the country's battle against Covid-19 will look like.

The holiday crowds mark the unofficial end to a devastating summer across the country, with Covid-19 infections surging to more than 6.3 million and deaths topping 189,000. Experts have offered a grim prediction on what the fall and winter could look like, with the pandemic stacking up against flu season and new fronts opening up, including schools and college campuses. 

New challenges ahead: With cooler weather ahead, it's likely many of the gatherings that have already been taking place -- many against experts' advice -- will now move indoors, where health officials have said the virus can spread more easily.

Masks: Months into the pandemic, safety measures like face masks remain a point of contention nationwide -- despite experts' projections that more mask-wearing could mean thousands of lives saved by the end of the year.

Campuses and schools: With tens of thousands of students back on campus, institutions are facing massive challenges. Covid-19 cases in colleges have been linked back to activities including athletics, off-campus gatherings and Greek life.

Read the full story:

Social distancing guidance is posted on a sign in the check-in area at Hong Kong International Airport on September 4. Marc Fernandes/NurPhoto/Getty Images

Officials in Hong Kong said they are discussing a potential travel bubble with 11 countries, as the territory is set to relax social distancing measures on Friday.

Hong Kong Secretary for Commerce and Economic Development Edward Yau said five or six nations have shown an interest, including Japan and Thailand.

Other countries discussed for the travel bubble are South Korea, Australia, New Zealand, Germany, France, Switzerland, Vietnam, Malaysia and Singapore. 

Yau said that travelers within the bubble might be required to take a coronavirus test before departure and upon arrival, and could be limited to visit a few tourist attractions with quotas.

Cases ease: Hong Kong reported six new Covid-19 cases in the past 24 hours, three of which were were locally transmitted. This is the lowest number of daily cases announced since a third wave of the virus hit the city in July.

Chinese President Xi Jinping, center, stands with honourees (from left) Chen Wei, Zhang Boli, Zhong Nanshan, and Zhang Dingyu, as they receive awards during a ceremony to honor people who fought against the pandemic, in Beijing, on September 8. Nicolas Asfouri/AFP/Getty Images

Chinese President Xi Jinping said China acted in an "open, transparent, and responsible manner" in its handling of the coronavirus pandemic.

Xi made the comments while awarding medals to four people for their outstanding contributions during the pandemic at a ceremony today in Beijing.

Among the four were the country's top respiratory disease expert, Zhong Nanshan, according to Chinese state broadcaster CCTV. 

Xi said China reported information on the virus "at the earliest time possible" to the World Health Organization "and relevant countries, regions and organizations."

"China is the first major economy to resume growth after the heavy blow of Covid-19, and is leading the world in virus control and prevention and economic recovery, which shows China's great capacity for restoration and exuberant vitality," he said.

China has been criticized for downplaying or even covering up the severity of the virus at the start of the pandemic, and for ignoring evidence that it spread from person-to-person until it was too late.

China has repeatedly denied these claims.

Hong Kong will enter its third phase of relaxing social distancing measures on Friday, Secretary for Food and Health Sophia Chan said in a news conference today.

This phase will see the number of diners allowed to eat together at restaurants increased from two to four, and allows certain entertainment venues to reopen, such as arcades, performance venues, mahjong centers, indoor sports facilities and public entertainment venues.

The third phase will also allow up to four people to gather publicly instead of two.

Amusement parks -- including popular attractions Disneyland and Ocean Park -- can "hopefully" reopen on September 18, Secretary for Commerce and Economic Development Edward Yau added.

Travel bubble talks: Yau also said Hong Kong is discussing a potential travel bubble with 11 countries. Five or six nations have shown an interest, including Japan and Thailand, he said.

Other countries discussed for the travel bubble are South Korea, Australia, New Zealand, Germany, France, Switzerland, Vietnam, Malaysia and Singapore. 

Yau added that travelers within the bubble might be required to take a coronavirus test before departure and upon arrival, and could be limited to visit a few tourist attractions with quotas.

About 15,500 passengers traveled on the Delhi metro in India on Monday, the first day that subway trains came back into service after a five-month closure due to the pandemic.

That's a little over one-hundredth of the 1.5 million people who traveled on these trains daily prior to lockdown measures, according to the Delhi Metro Rail Corporation (DMRC). 

Trains had reduced operating times -- running for four hours in the morning and four hours in the evening -- and reducing the carrying capacity to just 20% compared to usual.

The metro resumed services of one of its busiest lines on Monday and its nine other routes will resume operations in a graded manner by September 12. DMRC has also advised passengers to avoid non-essential travel to avoid over crowding. 

All public transport, including suburban trains, was suspended when India announced a nationwide lockdown on March 24, amid a growing coronavirus epidemic.

Rising cases: The trains resumed operations as infections surged to a fresh daily high of 90,802 new cases Monday that saw India surpass Brazil as the country with the second-highest number of total cases, after the United States.

On Tuesday, India recorded 75,809 new coronavirus cases and 1,133 deaths, according to the Indian Ministry of Health. 

That brings the nationwide total to 4,280,422 cases, including 72,775 deaths, the ministry said.

The United States recorded 24,362 new cases of the novel coronavirus on Monday, bringing the nationwide total to at least 6,300,727 infections, according to Johns Hopkins University.

The death toll rose to at least 189,206 after 265 new virus-related fatalities were also recorded Monday.

The totals include cases from all 50 states, the District of Columbia and other US territories, as well as repatriated cases.  

CNN is tracking US coronavirus cases here: