Monthly Archives: May 2021

Passengers, some wearing protective face coverings and some not, travel during rush hour on the London Underground last month. Tolga Akmen/AFP via Getty Images hide caption

Passengers, some wearing protective face coverings and some not, travel during rush hour on the London Underground last month.

LONDON England, Scotland and Northern Ireland on Monday recorded no new COVID-19 deaths a milestone that health experts said represents an encouraging sign, but caution could be temporary.

Meanwhile, Wales recorded just four coronavirus-related deaths. Even so, it's a sharp contrast to a January peak across the U.K., when about 1,800 deaths were recorded in a single day.

Although it is likely that because of reporting delays, more deaths will be reported in the coming days, the number of confirmed infections in the U.K. is also down, suggesting the trend is heading in the right direction.

Dr. Michael Head, a senior research fellow in global health at the University of Southampton, told The Guardian that reported deaths often reflect "lag time in system."

"However, regardless of reporting idiosyncrasies, the daily numbers of COVID-19 deaths are much lower than even three months ago," he said.

Experts said the improving numbers were an indication that vaccinations now hovering around 600,000 people per day for both first and second doses were having a positive impact.

The latest numbers come as the U.K.'s coronavirus alert level has been lowered from four to three, meaning the virus is still in general circulation, but that transmission is no longer rising exponentially.

Prime Minister Boris Johnson on Monday also confirmed that restrictions put in place to contain the spread of coronavirus were set to be eased. He said people in England would be able to hug loved ones, dine and drink inside restaurants and pubs, and travel abroad on vacation from May 17.

As lockdown has gradually eased, the country is rumbling back to life. London tube trains, largely empty for months, are becoming packed again and traffic has returned to London's suburbs.

Many commuters on public transport continued to don masks as required, but fewer are wearing them while walking along the streets.

In Scotland, indoor seating in pubs and restaurants has already returned, but with an 8 p.m. close and no alcohol service indoors. Coronavirus restrictions are managed on a regional basis with the governments of Wales, Scotland and Northern Ireland making their own rules.

NPR's Scott Neuman reported from Washington.

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No New COVID-19 Deaths Reported In Most Of U.K., As Restrictions Set To Ease - NPR

For Immediate Release: May 10, 2021

Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.

The FDAs expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic, said Acting FDA Commissioner Janet Woodcock, M.D. Todays action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.

From March 1, 2020 through April 30, 2021, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention (CDC). Children and adolescents generally have a milder COVID-19 disease course as compared to adults. The Pfizer-BioNTech COVID-19 Vaccine is administered as a series of two doses, three weeks apart, the same dosage and dosing regimen for 16 years of age and older.

The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria to amend the EUA, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccines use in this population.

Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic, said Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research. With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older.

The FDA has updated the Fact Sheets for Healthcare Providers Administering the Vaccine (Vaccination Providers) and for Recipients and Caregivers with information to reflect the use of the vaccine in the adolescent population, including the benefits and risks of the Pfizer-BioNTech COVID-19 Vaccine.

The EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine was issued to Pfizer Inc. The issuance of an EUA is not an FDA approval (licensure) of a vaccine. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated, and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance or to protect public health or safety.

The available safety data to support the EUA in adolescents down to 12 years of age, include 2,260 participants ages 12 through 15 years old enrolled in an ongoing randomized, placebo-controlled clinical trial in the United States. Of these, 1,131 adolescent participants received the vaccine and 1,129 received a saline placebo. More than half of the participants were followed for safety for at least two months following the second dose.

The most commonly reported side effects in the adolescent clinical trial participants, which typically lasted 1-3 days, were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain. With the exception of pain at the injection site, more adolescents reported these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose. The side effects in adolescents were consistent with those reported in clinical trial participants 16 years of age and older. It is important to note that as a general matter, while some individuals experience side effects following any vaccination, not every individuals experience will be the same and some people may not experience side effects.

The Pfizer-BioNTech COVID-19 Vaccine should not be given to anyone with a known history of a severe allergic reaction, including anaphylaxisto any component of the vaccine. Since its authorization for emergency use, rare severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine in some recipients.

The effectiveness data to support the EUA in adolescents down to 12 years of age is based on immunogenicity and an analysis of COVID-19 cases. The immune response to the vaccine in 190 participants, 12 through 15 years of age, was compared to the immune response of 170 participants, 16 through 25 years of age. In this analysis, the immune response of adolescents was non-inferior to (at least as good as) the immune response of the older participants. An analysis of cases of COVID-19 occurring among participants, 12 through 15 years of age, seven days after the second dose was also conducted. In this analysis, among participants without evidence of prior infection with SARS-CoV-2, no cases of COVID-19 occurred among 1,005 vaccine recipients and 16 cases of COVID-19 occurred among 978 placebo recipients; the vaccine was 100% effective in preventing COVID-19. At this time, there are limited data to address whether the vaccine can prevent transmission of the virus from person to person. In addition, at this time, data are not available to determine how long the vaccine will provide protection.

As part of the original EUA request, Pfizer Inc. submitted a plan to continue monitoring the safety of the vaccine as it is used under EUA. This plan has been updated to include the newly authorized adolescent population, and includes longer-term safety follow-up for participants enrolled in ongoing clinical trials, as well as other activities aimed at monitoring the safety of the Pfizer-BioNTech COVID-19 vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.

It is mandatory for Pfizer Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System for Pfizer-BioNTech COVID-19 Vaccine: all vaccine administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalization or death.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight...

People who need help getting to a vaccination site will be able to get free or discounted rides through Uber and Lyft, the White House says. Here, a woman receives her first dose of the Pfizer vaccine at a mass vaccination site in Aberdeen, Md., after getting a ride to the site from her landlord. Chip Somodevilla/Getty Images hide caption

People who need help getting to a vaccination site will be able to get free or discounted rides through Uber and Lyft, the White House says. Here, a woman receives her first dose of the Pfizer vaccine at a mass vaccination site in Aberdeen, Md., after getting a ride to the site from her landlord.

Anyone needing a ride to get a COVID-19 vaccine shot will be able to get a free trip from the ride-sharing companies Lyft and Uber, the White House announced Tuesday, in the latest push to encourage Americans to get vaccinated.

"The feature will launch in the next two weeks and run until July 4," the White House said.

People who want to use the program would need to select a vaccination site near them and then redeem the companies' offer of a free ride. The two ride-sharing firms will promote the offer in their apps.

The initiative is a new facet of President Biden's push to ensure 70% of all U.S. adults get at least one vaccine shot by July 4. The two companies are "driving America closer" to reaching that goal, the White House said.

More than 58% of American adults have now received at least one vaccination shot, the Centers for Disease Control and Prevention said on Tuesday. More than 44% of adults are fully vaccinated.

Lyft says it will offer a "ride code" to cover up to $15 of each trip to or from a vaccination site, adding that it expects the code will erase "most, if not all, of riders' fares." The offer covers daytime rides on bikes and scooters, as well as in cars. People will be able to sign up for their ride code by May 24, the company said.

Uber did not immediately provide details about its plan, but both Uber and Lyft have previously pledged to offer millions of rides to people who need help getting to a vaccine appointment.

In Uber's earlier effort, the company promised to provide up to 10 million free or discounted rides to help people get vaccinated, particularly "communities of color that have been disproportionately hurt by the pandemic," as the company said in December.

In another part of the U.S. effort to make it easier for people to get vaccinated, the White House says the government will broker partnerships between retail pharmacies and community colleges, which will then host vaccination clinics for students, staff and local communities.

The U.S. has reported more than 32.7 million COVID-19 cases, including more than 582,000 deaths, according to data compiled by Johns Hopkins University.

Read more:

Uber And Lyft Will Give Free Rides To COVID-19 Vaccination Spots, White House Says - NPR