Tag Archives: COVID-19 vaccine

U.S. CDC panel backs COVID-19 vaccine now cleared for adolescents

By Michael Erman and Manojna Maddipatla

(Reuters) -U.S. states are set to begin using the vaccine from Pfizer Inc and BioNTech SE to inoculate younger adolescents against COVID-19 after advisers to the U.S. Centers for Disease Control and Prevention (CDC) backed the plan in a unanimous vote on Wednesday.

The U.S. Food and Drug Administration on Monday authorized the vaccine for children aged 12 to 15, offering relief to parents eager to get their children back to schools and summer camps, and the action by the CDC group is an important, but not required, final seal of federal regulatory approval.

Some states, including Georgia, Delaware and Arkansas, began offering the vaccine to younger teens on Tuesday.

The Advisory Committee on Immunization Practices (ACIP), which provides recommendations to the CDC, voted 14-0 to back the vaccine, after reviewing trial evidence that showed no one in the 12-15 age group who received the vaccine got COVID-19, and there were no cases of Bell’s Palsy or severe allergic reactions.

Moreover, the vaccine produced robust antibody responses in the age group and showed 100% efficacy in the trial, with no cases of symptomatic COVID-19 among the fully vaccinated adolescents.

“This will provide protection for 12 to 15 year old’s,” said Dr. Henry Bernstein, a member of the advisory committee and professor of pediatrics at Zucker School of Medicine at Hofstra/Northwell. “It will decrease transmission within their family. It will contribute to community immunity, and it allows the kids to more safely go back to camps this summer, and back for in-person school.”

About a third of all Americans have been fully-vaccinated according to the CDC data. But the pace of vaccination has slowed in the recent weeks.

The rollout of a vaccine for adolescents should help further limit the spread of the virus at a time when more contagious variants are circulating, and could shorten the road to normalcy for Americans.

“I think we should be in full school, full in-person school, in the fall,” CDC Director Rochelle Walensky said at a CNBC health summit on Tuesday.

Children have been considered by health officials as being at a lower risk for severe COVID-19, but they can still spread the virus. More than 1.5 million cases have been reported among 12- to 17-year-olds, and as more adults become vaccinated, adolescents are accounting for a higher proportion of total cases.

Adjusted for underreporting, the working group estimated 22.2 million U.S. COVID-19 infections in those aged 5 to 17.

Pfizer is running a separate trial testing the vaccine in children as young as 6-months-old, and has said it expects data on its use in 2- to 11-year-olds in September. The 2,260 participants in the 12-to-15 age group – half of whom were given placebo – were tested as an expansion of Pfizer’s more than 46,000-person trial.

The committee will hear from Pfizer about the vaccine’s safety and efficacy in adolescents and will consider the views of a handful of CDC officials on its implementation.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Caroline Humer, Peter Henderson and Bill Berkrot)

‘Want the COVID-19 vaccine? Have a U.S. visa?’ Latinos travel north for the shot

By Anthony Esposito, Cassandra Garrison and Marco Aquino

MEXICO CITY/LIMA (Reuters) – “Want the COVID-19 vaccine? Have a U.S. visa? Contact us,” reads a travel agency advertisement, offering deals to Mexicans to fly to the United States to get inoculated.

From Mexico to far-flung Argentina, thousands of Latin Americans are booking flights to the United States to take advantage of one of the world’s most successful vaccination campaigns, as rollouts in their own countries sputter.

Latin America is one of the regions worst affected by the coronavirus pandemic, with the death toll set to pass 1 million this month, and many do not want to wait any longer for their turn to get vaccinated.

Some people are going it alone, while others have tapped travel agencies, which have responded by offering packages that arrange the vaccine appointment, flights, hotel stay and even offer extras such as city and shopping tours.

Gloria Sanchez, 66, and her husband, Angel Menendez 69, traveled in late April to Las Vegas to get Johnson & Johnson’s single dose vaccine.

“We don’t trust the public health services in this country,” said Sanchez, now back in Mexico. “If we hadn’t traveled to the United States where I felt a little more comfortable I wouldn’t have gotten vaccinated here.”

A travel agent in Mexico City organized the trip for them and an associate in Las Vegas handled things on the U.S. side, Sanchez said.

The U.S.-based associate signed them up for a vaccine appointment, then drove them to a Las Vegas convention center where they presented their Mexican passports and received their shots.

“We decided to make it a vacation and we went for a whole week, walked like crazy, ate really expensive but good food, and did some shopping,” said Sanchez.

As demand has boomed, flight prices from Mexico to the United States have risen an average of 30%-40% since mid-March, said Rey Sanchez, who runs travel agency RSC Travel World.

“There are thousands of Mexicans and thousands of Latin Americans who have gone to the United States to get vaccinated,” he said, adding that the top destinations have been Houston, Dallas, Miami and Las Vegas.

Reuters was unable to find official data on how many Latin Americans are traveling to the United States to get vaccinated. Travelers do not generally state vaccination as a reason to travel.

But U.S. cities have caught on to the trend, which is ushering much needed business into cash-strapped hotels, restaurants and other service activities.

“Welcome to New York, your vaccine is waiting for you! We’ll administer the Johnson & Johnson vaccine at iconic sites across our city,” New York City’s government announced on Twitter on May 6.

The U.S. embassy in Peru recently advised residents on Twitter that travelers could visit the United States for medical treatment, including vaccinations.

Latin Americans who had traveled on a U.S. tourist visa that Reuters spoke to said they were able to obtain shots with IDs from their home countries.

As far south as Argentina, travel agencies are selling vaccination tourism trips.

An advertisement in Buenos Aires details the estimated cost of getting vaccinated in Miami: air ticket $2,000, hotel for a week $550, food $350, car rental $500, vaccine $0. For a total of $3,400.

NO HOPE OF A VACCINE SOON

While initially it was mostly wealthy Latin Americans looking to travel, increasingly people with more modest means are making bookings. For many, the cost of lengthy flights makes it a major undertaking.

“I’m getting money together to travel to California in June,” said a worker at a car parts store in Lima, who asked not to be named for fear it could jeopardize his travel plans. “Considering how things are going here, there’s no hope of a vaccine shot soon.”

The slow rollout of vaccinations in most Latin American countries was a common reason cited for traveling to the United States, said Sanchez.

With little to no infrastructure to make vaccines domestically, campaigns in Latin America have been hampered by supply delays and shortages. The United States has administered nearly 262 million vaccine doses, some 2.3 times the number of shots given in all of Latin America, which has roughly twice the population, according to figures from the U.S. Centers for Disease Control and Prevention and Our World in Data.

Distrust in vaccination campaigns in Latin America is also a factor, said Sanchez.

Reports of batches of fake doses being seized by authorities or the required second dose not being available when it was time are some of the reasons Latin Americans gave for their distrust.

Vaccine tourism has fueled a jump in air travel to the United States, with fares for some last-minute flights doubling or even tripling since January, even as airlines increase capacity, according to Rene Armas Maes, commercial vice president at MIDAS Aviation, a London-based consultancy.

LATAM Airlines Group, the region’s largest carrier, said on Thursday it was seeing increased demand from South Americans seeking to travel to the United States to get vaccinated against the coronavirus.

Aeromexico said passenger traffic between Mexico and the United States increased 35% from March to April.

And American Airlines also said it had seen demand growing rapidly from parts of Latin America in recent months and it had increased capacity, particularly to Colombia, Ecuador and Mexico.

“We’re matching the increased demand in many of these markets, with additional frequencies, new routes or with the use of widebody aircraft, resulting in more capacity,” said American Airlines.

For 29-year-old Giuliana Colameo, the chance to get vaccinated was a relief after she and her boyfriend in Mexico City were both infected by the coronavirus in 2020.

They traveled to New York City where they got vaccinated at a pharmacy last month. She said they were the only two people getting the shots.

“When they give you the vaccine it’s like you almost cry. It’s a relief: it gives you hope,” said Colameo. “I feel very happy I did it and hopefully more people can do it.”

(Reporting by Anthony Esposito and Cassandra Garrison in Mexico City and Marco Aquino in Lima; Additional reporting by Carolina Mandl in Sao Paulo and Anthony Boadle in Brasilia; Writing by Anthony Esposito; Editing by Rosalba O’Brien)

CDC advances plan for resumption of U.S. passenger cruise operations

By David Shepardson

WASHINGTON (Reuters) – The U.S. Centers for Disease Control and Prevention (CDC) has begun a key step for the eventual resumption of U.S. cruise industry operations by issuing new technical instructions.

In October, the CDC issued Conditional Sailing Order for operators, which acted as a guidance for a phased resumption of cruise ship passenger operations.

On Wednesday, it announced two new phases and said operators now have all necessary requirements needed “to start simulated voyages before resuming restricted passenger voyages and apply for a COVID-19 conditional sailing certificate to begin sailing with restricted passenger voyages.”

The CDC said on April 28 it was “committed” to the resumption of cruise industry passenger operations by mid-summer as it issued some clarifications of its earlier order.

The agency also released the COVID-19 Conditional Sailing Certificate application, “the final step before restricted passenger voyages.”

The new guidance includes eligibility and requirements for conducting a trial voyage in preparation for restricted passenger voyages and for CDC cruise ships inspections during simulated and restricted passenger voyages.

Once cruise ships operators receive approved COVID-19 Conditional Sailing Certificate applications, they will be permitted to sail with passengers.

The Cruise Lines International Association, which represents Carnival Corp, Norwegian Cruise Line and Royal Caribbean Cruises, said Wednesday it was reviewing the CDC’s latest instructions. The association said last week it was optimistic that CDC “clarifications show positive progression—and, importantly, a demonstrated commitment to constructive dialogue, which is key to restarting cruising.”

The group added “plenty of work remains in order to achieve our mutual goal of responsible resumption from U.S. ports this summer.”

Florida and Alaska have filed a lawsuit seeking to force the CDC to immediately allow the resumption of cruise operations.

The CDC said COVID-19 vaccines “play a critical role in the safe resumption of passenger operations, but not all cruise ship operators have announced plans to mandate passenger vaccinations.”

The agency said it “recommends that all port personnel and travelers (passengers and crew) get a COVID-19 vaccine.”

(Reporting by David Shepardson; Editing by Aurora Ellis)

White House to shift COVID-19 vaccine to states with more need

WASHINGTON (Reuters) -The White House told U.S. states on Tuesday they can no longer carry over unordered doses of their weekly COVID-19 vaccine allocations and that unused doses will instead be shifted to states with greater demand, the Washington Post reported.

COVID-19 vaccines are currently allocated state by state based on population – a formula the Biden administration held to even as some states such as Michigan saw recent surges of the coronavirus.

But White House Coronavirus Task Force Coordinator Jeff Zients told the Washington Post in an interview that the change in allocation reflects the next phase in the White House’s efforts to inoculate the population.

“There is a need to add more flexibility to the current system,” he told the news outlet.

The shift also comes as new U.S. COVID-19 cases fell for the third week in a row. About 30.5% of the U.S. population, or about 101,407,318 people, have been fully vaccinated as of last week.

Representatives for the White House could not be immediately reached for comment on the report.

(Reporting by Susan Heavey; Editing by Tim Ahmann and Nick Macfie)

Fully vaccinated people can unmask outdoors in some cases: U.S. CDC

(Reuters) – Fully vaccinated people can safely engage in outdoor activities like walking and hiking without wearing masks but should continue to use face-coverings in public spaces where they are required, U.S. health regulators said on Tuesday.

The updated health advice comes as more than half of all adults in the United States have now received at least one dose of COVID-19 vaccine, according to the U.S. Centers for Disease Control and Prevention (CDC).

“The release of these new guidelines is a first step at helping fully vaccinated Americans resume activities they had stopped doing because of the pandemic, while being mindful of the potential risk of transmitting the virus to others,” the CDC said.

Wearing face masks has been considered by experts as one of the most effective ways of controlling virus transmission. With most COVID-19 transmission occurring indoors, and vaccinations on the rise, the use of masks outdoors has been under public debate for weeks in the United States as Americans look to enjoy the benefits of being fully vaccinated.

New COVID-19 cases have dropped 16% in the last week as the U.S. surpassed 140 million people having received at least one shot of authorized vaccines from Pfizer/BioNTech, Moderna or Johnson & Johnson’s one-dose vaccine.

This was the biggest percentage drop in weekly new cases since February, according to a Reuters analysis of state and county data.

SMALL OUTDOOR GATHERINGS

The agency said fully-vaccinated Americans can safely dine outdoors with friends from multiple households at restaurants and attend small outdoor gatherings with a mixture of fully vaccinated and unvaccinated people.

CDC continues to recommend masking for crowded outdoor events such as parades and sporting events and indoor visits to the hair salon, shopping malls, movie theaters and houses of worship.

The agency classified activities as “red,” “yellow” and “green” based on level of safety for unvaccinated people.

It said unvaccinated people can also walk and run unmasked with household members outdoors safely and attend small outdoor gatherings with fully vaccinated family and friends.

Data on whether vaccinated people can spread infection to those who did not receive their shots is limited and the CDC warned that people should evaluate risk to friends and family before going out without masks.

This is an update to the CDC’s guidance, which in March said people who have been fully vaccinated against COVID-19 can meet without masks indoors in small groups with others who also have been inoculated.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Caroline Humer and Bill Berkrot)

Return the favor: South Korea looks to U.S. for COVID-19 vaccine aid

By Sangmi Cha

SEOUL (Reuters) – South Korea hopes the United States will help it tackle a shortage of coronavirus vaccine in return for test kits and masks Seoul sent to Washington earlier in the pandemic, the foreign minister said on Wednesday.

The government has drawn fire from the media for not doing enough to secure enough vaccines early, with just 3% of the population inoculated, due to tight global supply and limited access.

“We have been stressing to the United States that ‘A friend in need is a friend indeed,'” the minister, Chung Eui-yong, told reporters at the Kwanhun Club of South Korean journalists.

He said South Korea had airlifted Washington a large volume of coronavirus test kits and face masks in the early stages of the pandemic “in the spirit of the special South Korea-U.S. alliance,” despite tight domestic supply at the time.

“We are hoping that the United States will help us out with the challenges we are facing with the vaccines, based on the solidarity we demonstrated last year.”

The allies were in talks, added Chung, who also flagged South Korea’s potential contribution to preserving a global semiconductor supply chain U.S. President Joe Biden is keen to maintain.

Diplomatic efforts have not yielded any concrete steps, however, as the talks with Washington are still in an early stage, health ministry official Son Young-rae told reporters.

Opposition lawmaker Park Jin urged more aggressive vaccine diplomacy, calling for the government to invoke its free trade pact (FTA) with Washington to secure pharmaceutical products.

“The government needs to be more proactive,” Park told Reuters.

“The FTA provides us a legal base to demand (vaccines) as it stipulates the two countries’ commitment to promoting the development of, and facilitating access to, pharmaceutical products.”

The U.S. embassy in Seoul did not immediately reply to a Reuters’ request for comment.

About 1.77 million people in South Korea have had their first dose of the AstraZeneca Plc or Pfizer vaccines. The low rate compares with a 40% vaccination rate in the United States, according to Reuters data.

Tuesday’s 731 new coronavirus infections, up from 549 cases a day earlier, took South Korea’s tally to 115,926, with 1,806 deaths.

J&J stands ready to roll out COVID-19 vaccine in Europe as regulators weigh risks

By Manas Mishra and Carl O’Donnell

(Reuters) -Johnson & Johnson said on Tuesday it stands ready to resume rolling out its COVID-19 vaccine in Europe, where the region’s medical regulator said the benefits of the shot outweigh the risk of very rare, potentially lethal blood clots.

Use of the company’s one-dose vaccine was temporarily halted by U.S. regulators last week after the rare brain blood clots combined with a low blood platelet count were reported in six women, prompting the company to delay its rollout in Europe.

Europe’s health regulator, the European Medicines Agency, on Tuesday recommended adding a warning about blood clots with low blood platelet count to the vaccine’s product label, but said the benefits of the one-dose shot outweigh its risks.

J&J earlier on Tuesday said it was set to resume vaccinations in Europe and was working with European countries to resume ongoing clinical trials for its shot.

“It’s an extremely rare event. We hope by making people aware as well as putting clear diagnostic and therapeutic guidance in place that we can restore the confidence in our vaccine,” said J&J’s Chief Scientific Officer Paul Stoffels.

The United States is also reviewing a handful of potential cases of severe side effects in addition to those that led to the pause.

“The outcome of the vaccine review is important for overall global vaccination efforts, given J&J’s vaccine does not have the extreme cold storage requirements of the mRNA vaccines,” Edward Jones analyst Ashtyn Evans said, referring to vaccines from Moderna Inc and Pfizer Inc with partner BioNTech SE.

Meanwhile, J&J is working with U.S. regulators to get clearance for its Baltimore-based vaccine production plant, owned by Emergent BioSolutions Inc, and expects feedback in the coming days. Emergent shut down production at its plant earlier this month after manufacturing errors ruined millions of J&J doses in March.

“We are remediating what we need to remediate. We think that will lend itself to a positive outcome,” said J&J Chief Financial Officer Joseph Wolk during a call to discuss quarterly results. He said J&J “should know more in the next couple of days.”

Nearly 8 million people had received the J&J vaccine in the United States prior to the halt.

J&J said it would fulfill its commitments to ship 200 million doses in Europe and 100 million in the United States.

The company said it recorded $100 million in COVID-19 vaccine sales. J&J has said the vaccine will be available on a not-for-profit basis until the end of the pandemic.

An advisory committee to the U.S. Centers for Disease Control and Prevention is expected to meet on Friday to address the pause after it delayed making any recommendations in a meeting last week and called for more data.

Johnson & Johnson reported first-quarter earnings that exceeded Wall Street expectations and raised its dividend payouts to shareholders.

The company said it expects a big improvement in sales from its medical device business in the second quarter of 2021 compared with a year earlier, when COVID-19 lockdowns took a toll.

J&J slightly raised its full-year adjusted profit forecast and now sees earnings of $9.42 to $9.57 per share, up from its prior view of $9.40 to $9.60 per share.

Total sales rose 7.9% to $22.32 billion, beating estimates of $21.98 billion.

(Reporting by Manas Mishra, Manojna Maddipatla in Bengaluru and Carl O’Donnell in New York; Editing by Anil D’Silva and Bill Berkrot)

India to allow COVID-19 vaccines for all adults as cases surge

By Neha Arora and Anuron Kumar Mitra

NEW DELHI (Reuters) – India will let all citizens over 18 have COVID-19 vaccinations from May 1, the government said on Monday, as the health system creaked under the weight of record-high cases and the capital region of New Delhi ordered a lockdown.

Facing growing criticism over its handling of the second wave of the pandemic, Prime Minister Narendra Modi’s administration said vaccine manufacturers would have to supply 50% of doses to the federal government and the rest to state governments and the open market at a pre-declared price.

Daily COVID-19 cases in India jumped a record 273,810 on Monday, and deaths rose a record 1,619 to 178,769. Hospitals have a shortage of beds, oxygen and key medicines, and infections have passed 15 million, the world’s second highest total after the United States.

The New Delhi region ordered a six-day lockdown starting Monday night after its chief minister said the health system was unable to take more patients in big numbers.

“If a lockdown isn’t implemented now, the situation will go beyond control,” Chief Minister Arvind Kejriwal told a virtual media briefing on Monday.

Criticism of Modi’s administration has increased as he continued to address large state election rallies and let Hindu devotees congregate for a festival.

Kejriwal had said on Sunday that fewer than 100 critical care beds were available in the city of New Delhi, which has a population of more than 20 million people, and social media were flooded with complaints.

New Delhi joined 13 other Indian states that have decided to impose restrictions, curfews or lockdowns in their cities, including the richest state of Maharashtra and Modi’s home state of Gujarat, where the industrial city of Ahmedabad is also grappling with a shortage of beds.

Hong Kong said late on Sunday that the Asian financial hub will suspend flights from India, Pakistan and the Philippines from Tuesday for two weeks.

Britain has put India on a travel “red-list” and Prime Minister Boris Johnson cancelled a planned trip to India next week.

As of Monday, India had administered nearly 123.9 million vaccine doses – the most in the world after the United States and China, though it ranks much lower in per capita vaccination.

The current vaccination process is controlled by the federal government. Liberalizing it would augment vaccine production and availability, and attract new domestic and international vaccine manufacturers, the government said in its statement.

“It would also make pricing, procurement, eligibility and administration of vaccines open and flexible, allowing all stakeholders the flexibility to customise to local needs and dynamics,” it said.

(Reporting by Neha Arora in New Delhi, Anuron Kumar Mitra and Nivedita Bhattacharjee in Bengaluru; additional reporting by Sumit Khanna in Ahmedabad and Aftab Ahmed in New Delhi; Editing by Christian Schmollinger, Michael Perry, Nick Macfie and Timothy Heritage)

Native health providers drive Alaska’s vaccination success story

By Yereth Rosen

ANCHORAGE, Alaska (Reuters) Despite its sprawling geography and often-inhospitable climate, Alaska ranks among the top U.S. states for getting COVID-19 vaccine into the arms of its residents, and its indigenous population has played a major role in that achievement.

With a history and culture deeply shaped by deadly outbreaks of disease that have periodically ravaged remote corners of their subarctic homeland, Alaska Natives have aggressively led the way on inoculations against COVID-19 for the state as a whole.

Through their federally recognized sovereign powers, Alaska Native tribes has secured larger vaccine supplies from the U.S. Indian Health Service (IHS) than the state government has obtained for itself, said Tiffany Zulkosky, a Yup’ik and state legislator from the southwestern Alaska community of Bethel.

As a result, tribal health organizations primarily serving indigenous communities – representing just 18% of the state’s 730,000 inhabitants – have played an outsized role in the state’s overall vaccine campaign.

Acting Anchorage Mayor Austin Quinn-Davidson, who is white, tweeted a photo of herself getting a shot courtesy of a Native organization in early March.

“Alaska is leading the country in vaccinations because of the incredible work and generosity of our Tribal partners,” she wrote.

By early April, more than 42% of all Alaska residents aged 16 and older had received at least a first dose of a COVID-19 vaccine, ranking near the top among states with the highest rates of inoculation per capita and by percentage of population.

The percentages run higher in regions dominated by Native populations, which have been particularly hard hit by the pandemic.

Although precise figures are hard to come by, a significant number of shots received by the general public come from the IHS supply or are being administered by tribal networks, said Zulkosky, a vice president of the Yukon-Kuskokwim Health Corp, which serves a region the size of Oregon.

Besides the impetus of achieving herd immunity, “there is that cultural value of sharing and taking care of one another,” she said.

In some extremely remote Native villages vaccination rates are now approaching 90 percent, according to state data. Tribal providers prioritized those villages for early vaccine delivery because they tend to have limited medical services and often lack modern plumbing and sewage systems.

‘OVERWHELMING HAPPINESS’

Karma Ulvi, tribal leader in the onetime gold rush outpost of Eagle, home to about 120 people – half of them Alaska Natives – on the Yukon River near the Canadian border, said the arrival of vaccines there came as a great relief.

By early April, nearly the entire community was vaccinated, Ulvi told Reuters, stressing the importance of immunization in a place where only about three in every 20 households have running water, making good hand hygiene difficult.

“There was just an overwhelming happiness among people here that received it,” she said of the vaccines.

With limited phone and internet service and no wintertime road access, the nearest hospital is at least three hours away by aircraft. Even then “it’s very hard to be in touch with the plane if there’s an accident or if someone is sick,” Ulvi said.

To reach such communities, tribal health providers used bush planes, boats, snow machines and even sleds.

The campaign hearkened back to the famous 1925 Serum Run, when a dog-sled relay delivered life-saving diphtheria medicine to Nome. The Yukon-Kuskokwim Health Corp dubbed its COVID-19 vaccine-delivery system Project Togo, after a celebrated lead dog in the storied serum run.

CULTURAL SURVIVAL

Alaska Natives imposed some of the nation’s earliest and most robust lockdowns, mask mandates and other rules to curb the pandemic. The virus reached rural sites nonetheless, with some devastating results. Indigenous people accounted for 37 percent of COVID-19 deaths in the state last year, more than twice their proportion of the population, according to the state epidemiology office.

The Native COVID-19 death rate was nearly four times that for white Alaskans, according to state data.

The present-day tribal response is also colored by memories of past trauma, including the 1918 influenza pandemic that shattered Native communities, virtually wiping out entire villages.

The “Great Flu” is a particularly vivid cultural loss, said PJ Simon, chairman of the Tanana Chiefs Conference, a consortium of Athabascan tribes in interior Alaska.

“Some families will never know their last name because they all died,” he told Reuters. “People were reeling. Sometimes just a kid or a boy or girl survived and the rest of the family died and everyone else was trying to get back to normal, much like we are trying to do right now.”

Pfizer, BioNTech seek U.S. emergency nod for COVID-19 vaccine in adolescents

By Michael Erman and Mrinalika Roy

(Reuters) – Pfizer Inc and its German partner BioNTech SE on Friday asked U.S. regulators to allow the emergency use of their vaccine in adolescents aged 12 to 15.

The vaccine is currently authorized for emergency use in the United States for people aged 16 and up. The companies said on Friday that they requested an expansion of the authorization from the U.S. Food and Drug Administration to include the younger age group.

In March, the drugmakers said the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year old’s in a clinical trial.

It is unclear how long the regulator will take to review the data from the trial, although U.S. Centers for Disease Control director Rochelle Walensky told ABC news on Thursday that she expects the vaccine to be authorized for 12 to 15 year olds by mid-May.

It is also unclear whether the regulator will require a meeting of the independent advisory board that recommended the original authorization in order for the companies to receive the nod in the younger age group.

Moderna Inc and Johnson & Johnson are also testing their vaccines in 12- to 18-year old’s, and data from Moderna’s trial could come soon.

Pfizer and Moderna have also launched trials in even younger children, aged six months to 11 years old. Both companies have said they hope to be able to vaccinate children under 11 as soon as early 2022.

Inoculating children and young people is considered a critical step toward reaching herd immunity and taming the pandemic, according to many experts.

Pfizer and BioNtech said they plan to ask other regulatory authorities globally to allow the use of their vaccine in 12- to 15-year old’s in the coming days.