May 4 coronavirus news

Pfizer expects to submit for US Food and Drug Administration emergency use authorization for its Covid-19 vaccine for children ages 2 to 11 in September, the company said during its first quarter earnings teleconference on Tuesday. 

The pediatric safety and efficacy study in children ages 6 months to 11 years old is ongoing.  

Pfizer CEO Albert Bourla said in prepared remarks, adding that the readout and submission for children 6 months to 2 years is expected in the fourth quarter of 2021. 

Phase 2 safety data from Pfizer’s ongoing study in pregnant women is expected by late July or early August, Bourla said. 

Bourla also said the company expects to hear back shortly on its application for extended EUA for the vaccine to include 12-to-15-year-olds. On Monday, a federal government official said the FDA is poised to authorize the Pfizer coronavirus vaccine for that age group by early next week.

Pfizer has submitted information to the US Food and Drug Administration that may allow its Covid-19 vaccine to be stored at standard refrigerator temperatures, the company’s CEO said Tuesday. Such a change could help simplify distribution of the vaccine.

Pfizer CEO Albert Bourla said in an earnings meeting on Tuesday the company submitted new data to the FDA on Friday, and it may “soon” have an emergency use authorization to allow standard refrigeration for up to four weeks. 

Currently, Pfizer’s vaccine is authorized to be stored at ultra-cold temperatures, between -80 and -60 degrees Celsius, or in cold storage, between -25 and -15 degrees Celsius, for a maximum of two weeks, which can complicate distribution of the vaccine. 

According to Bourla, new data could allow the vaccine to be stored at standard temperatures, between 2 and 8 degrees Celsius, for up to four weeks. 

Bourla said Pfizer is working on additional formulations that could further extend the storage time of the vaccine in both standard and ultra-cold refrigerators. 

Nepal has recorded its highest daily Covid-19 death toll of the pandemic so far, with 55 deaths recorded on Tuesday.

The country has also recorded another 7,587 new coronavirus cases in the last 24 hours, according to government data. 

As neighboring India continues to grapple with an unrelenting second wave of Covid-19, Nepal is seeing its own surge in case numbers.

It has seen a more than 1,200% rise in seven-day average of daily new Covid-19 cases since mid-April, CNN's calculation of data from Johns Hopkins University showed.

On average, the country is reporting 200 new daily cases per million people.   

Across the country 46 out of 77 districts are in either partial or full lockdown, including the capital Kathmandu, according to an official government notice on Tuesday.   

Pfizer expects to file for full US Food and Drug Administration approval of its Covid-19 vaccine for 16-to-85-year-olds by the end of May, the company said during its first quarter 2021 earning teleconference Tuesday. 

“While we are currently distributing our vaccine in the US under an Emergency Use Authorization (EUA), we expect to submit this month a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) seeking full approval for our Covid-19 vaccine for individuals 16 years of age and older,” Pfizer CEO Albert Bourla said in his remarks.

The United States is providing more than $100 million worth of aid to India, including oxygen supplies and "critical PPE and therapeutics," a US Embassy spokesperson in New Delhi told CNN.

Five of six planes filled with aid supplies have already arrived in India and more shipments are on the way, the spokesperson added.

"At the request of the Government of India, USAID provided these urgently needed supplies to the Indian Red Cross to ensure that they reach those most in need, as fast as possible," the embassy added.

The spokesperson deferred questions about deployment and use of materials to the Indian government.

Delhi's deputy chief minister has asked India’s Ministry of Defense to deploy military aid to help manage the Covid-19 crisis unfolding in Delhi -- and across India. 

Manish Sisodia told CNN he wrote a letter to Defense Minister Rajnath Singh on Sunday, asking for extra support.

“Since the entire health infrastructure machinery is overwhelmed with the management of existing hospitals and the upcoming Cover Hospitals/Care Centers, it will be a timely help to the people of Delhi if the Ministry of Defense, with the considerable resources at its command, is tasked with the responsibility to provide and man the additional Covid health facilities,” Sisodia wrote in the letter.

Delhi is also currently facing an acute shortage of oxygen supplies and medical personnel.

Sisodia has requested for the Armed Forces to provide cryogenic tankers to transport liquid oxygen and for medical and paramedical teams “to supplement the medical manpower of Delhi.”

Sisodia told CNN that he has not yet received a response to his letter, but that the defense minister is examining his request.

Eight Asiatic lions housed in a zoological park in a southern Indian state tested positive for Covid-19 last month, according to the Indian government. 

The Nehru Zoological Park in Hyderabad collected samples after the animals showed signs of respiratory distress. 

The Nehru Zoological Park is currently closed to visitors and an advisory has been issued to other institutions that house animals. 

"Based on experience with zoo animals elsewhere in the world that have experienced SARS-COV2 positive last year, there is no factual evidence that animals can transmit the disease to humans any further," the ministry said.

The European Union's medicines regulator has begun a rolling review of a Covid-19 vaccine developed by Chinese biopharmaceutical company, Sinovac Life Science.

In a statement issued on Thursday, the European Medicines Agency (EMA) said:

The rolling review process will enable the EMA to evaluate the Sinovac vaccine more quickly, it said, but added that it “cannot predict overall timelines.”

The EMA said it will communicate when the marketing authorization application has been submitted by the company.

Screams pierce the air as their loved ones take their final breaths. Others sit on the floor gasping to fill their lungs.

CNN's Clarissa Ward went inside a coronavirus ward at a hospital in India's Uttar Pradesh state, where five doctors are struggling to treat more than 100 patients but there are only 55 beds.

Kavita, 32, said she's been on the floor at Lala Lajpat Rai Memorial Medical College hospital for four days, begging for oxygen.

A family desperately tried to care for their 55-year-old mother in the ICU. They said they had been in the hospital for six days before getting a ventilator and had to bring their own oxygen cylinder.

The woman later succumbed as the family cried out in anguish. Her body was left in the intensive care unit for nearly an hour before it was moved.

The hospital administrator, Dr. Gyanendra Kumar, said the supply of oxygen isn't the problem, but they are too short-staffed.

A group of men wearing masks but no other personal protective equipment tell Ward that they move about 12 bodies per day.

"We should be wearing proper PPE," one said, "but even the doctors don't have it, so how can we?" 

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