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FDA advisers endorse 1-shot covid vaccine

by Compiled Democrat-Gazette Staff From Wire Reports | February 27, 2021 at 5:37 a.m.
A patient is assisted by National Guardsmen upon arriving at the COVID-19 vaccination site at the Augusta Civic Center, Friday, Feb. 26, 2021, in Augusta, Maine. Gov. Janet Mills said Mainers ages 60 and older may get the vaccine starting Wednesday, March 3. (AP Photo/Robert F. Bukaty)

WASHINGTON -- U.S. health advisers on Friday endorsed a one-dose covid-19 vaccine from Johnson & Johnson, putting the nation on the cusp of adding an easier-to-use option to fight the pandemic.

The Food and Drug Administration is expected to quickly follow the recommendation and make Johnson & Johnson's shot the third vaccine authorized for emergency use in the U.S. Vaccinations are picking up speed, but new supplies are urgently needed to stay ahead of a mutating virus that has killed more than 500,000 Americans.

After daylong discussions, the FDA panelists voted unanimously that the benefits of the vaccine outweighed the risks for adults. If the FDA agrees, shipments of a few million doses could begin as early as Monday.

"There's an urgency to get this done," said Dr. Jay Portnoy of Children's Mercy Hospital in Kansas City, Mo. "We're in a race between the virus mutating -- and new variants coming out that can cause further disease -- and stopping it."

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More than 47 million people in the U.S., or 14% of the population, have received at least one shot of the two-dose vaccines from Pfizer and Moderna, which FDA authorized in December. But the pace of vaccinations has been strained by limited supplies and delays from winter storms.

While early Johnson & Johnson supplies will be small, the company has said it can deliver 20 million doses by the end of March and 100 million by the end of June.

Johnson & Johnson's vaccine protects against the worst effects of covid-19 after one shot, and it can be stored up to three months at refrigerator temperatures, making it easier to handle than the previous vaccines, which must be frozen.

One challenge in rolling out the new vaccine will be explaining how protective the Johnson & Johnson shot is after the success of the first U.S. vaccines.

"It's important that people do not think that one vaccine is better than another," said panelist Dr. Cody Meissner of Tufts University.

The two-dose Pfizer and Moderna shots were found to be about 95% effective against symptomatic covid-19. The numbers from Johnson & Johnson's study are not that high, but it's not an apples-to-apples comparison. One dose of the Johnson & Johnson vaccine was 85% protective against the most severe covid-19. After adding in moderate cases, the total effectiveness dropped to about 66%.

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Some experts fear that lower number could feed public perceptions that Johnson & Johnson's shot is a "second-tier vaccine." But the difference in protection reflects when and where Johnson & Johnson conducted its studies.

The vaccine was tested in the U.S., Latin America and South Africa at a time when more contagious mutated versions of the virus were spreading. That wasn't the case last fall, when Pfizer and Moderna were wrapping up testing, and it's not clear if their numbers would hold against the most worrisome of those variants.

Importantly, the FDA reported this week that, just like its predecessors, the Johnson & Johnson shot offers strong protection against the worst outcomes, hospitalization and death.

While Johnson & Johnson is seeking FDA authorization for its single-dose version, the company also is studying whether a second dose boosts protection.

Panel member Dr. Paul Offit warned that offering a two-dose version of the vaccine down the road might cause problems.

"You can see where that would be confusing to people thinking, 'Maybe I didn't get what I needed,'" said Offit, a vaccine expert at Children's Hospital of Philadelphia. "It's a messaging challenge."

Johnson & Johnson representatives said they chose to begin with the single shot because the World Health Organization and other experts agreed it would be a faster, more effective tool in an emergency.

Cases and hospitalizations have fallen dramatically since their January peak that followed the winter holidays. But public-health officials warned that those gains may be stalling as more variants take root in the U.S.

"We may be done with the virus, but clearly the virus is not done with us," Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said during a White House briefing Friday. She noted that new coronavirus cases have increased over the past few days.

While it's too early to tell if the trend will last, Walensky said adding a third vaccine "will help protect more people faster." More vaccines are in the pipeline.

On Sunday, a CDC panel is expected to meet to recommend how to best prioritize use of the Johnson & Johnson vaccine.

NOT TIME TO 'RELAX'

Meanwhile, the federal government warned governors against relaxing pandemic control measures Friday, saying that a recent steep drop in U.S. coronavirus cases and deaths "may be stalling" and "potentially leveling off at still a very high number" -- a worrisome development that comes as more cases of concerning new variants have been found and could suggest that a return to normalcy is not yet quite as near as many Americans had hoped.

"Things are tenuous," Walensky said. "Now is not the time to relax restrictions."

Her warning was bolstered by Dr. Anthony Fauci, the government's top infectious-disease specialist, as the Biden administration scrambled to stay ahead of any new wave. President Joe Biden flew to Houston to showcase the government's latest mass vaccination site.

According to a New York Times database, virus cases across the United States appear to be leveling off from the steep decline that began in January, with figures comparable to those reported in late October. Cases have slightly increased week over week in recent days, although severe weather limited testing and reporting in Texas and other states the previous week, and not all states reported complete data on the Washington's Birthday holiday. The seven-day average of new cases was 77,800 as of Thursday.

While deaths tend to fluctuate more than cases and hospital admissions, Walensky said at the briefing Friday, the most recent seven-day average is slightly higher than the average earlier in the week. The seven-day average of newly reported deaths was 2,165, as of Thursday.

"We at CDC consider this a very concerning shift in the trajectory," she said, adding, "I want to be clear: Cases, hospital admissions and deaths -- all remain very high, and the recent shift in the pandemic must be taken extremely seriously."

Walensky said some of the rise may be attributable to new variants of the coronavirus that spread more efficiently and quickly. The so-called B.1.1.7 variant, which first emerged in Britain, now accounts for approximately 10% of all U.S. cases, up from 1% to 4% a few weeks ago, she said. The U.S. ability to track variants is much less robust than Britain's.

"I know people are tired; they want to get back to life, to normal," she said. "But we're not there yet."

As cases had declined, some governors around the United States have begun to relax pandemic restrictions. States with Republican governors appeared to be more eager to make rollbacks, although New York, which has a Democrat as governor, also has been easing restrictions on a variety of activities.

On Friday, Gov. Henry McMaster of South Carolina, a Republican, announced that on Monday, restaurants would be able to serve alcohol past 11 p.m., and residents would not need approval from the state to hold events with more than 250 people. To try to limit the spread of the virus, the state last year ordered bars to stop serving alcohol after 11 p.m., which is three hours earlier than the late-night bar crowd was used to.

On Thursday, Gov. Greg Abbott of Texas said he was considering lifting a statewide mask mandate in place since July.

In Mississippi, Gov. Tate Reeves said he also was considering pulling back some restrictions, particularly mask mandates for people who have been fully vaccinated. As of Friday, 13% of the state's population has received at least one shot, and 6.2% have received two, according to a New York Times database.

Fauci echoed Walensky's warnings that more rollbacks at state or local levels would be unwise, noting that case levels remained at a "very precarious position."

"We don't want to be people always looking at the dark side of things, but you want to be realistic," he said. "So we have to carefully look at what happens over the next week or so with those numbers before you start making the understandable need to relax on certain restrictions."

CANADA GETS ASTRAZENECA

Separately, Canadian regulators on Friday authorized AstraZeneca's coronavirus vaccine for all adults.

It is the third covid-19 vaccine given the green light by Canada, after those from Pfizer and Moderna.

"This is very encouraging news. It means more people vaccinated, and sooner," Prime Minister Justin Trudeau said, adding that the nation of 38 million people will now get 6.5 million doses in total before the end of March, 500,000 more now with the new approval.

The Canadian health agency approved the AstraZeneca vaccine for use in people 18 and over, expressing confidence it would work for the elderly even though some countries, including France, have authorized it only for use in people under 65, saying there is not enough evidence it works in older adults.

With trials showing about 62% efficacy, the vaccine appears to offer less protection than those already authorized, but experts have said any vaccine with an efficacy rate of over 50% could help stop the outbreak

"It's a good option," said Dr. Supriya Sharma, the health agency's chief medical adviser.

Sharma said no one has died or become severely ill in trials of the vaccines now approved by Canada or in those of Johnson & Johnson and Novavax shots, which could be approved soon.

Health authorities in Germany and other countries have raised concerns that AstraZeneca didn't test the vaccine in enough older people to prove it works for them, and indicated they would not recommend it for people over 65. Belgium has authorized it only for people 55 and under

The Canadian health agency said its decision was based on pooled analyses from four ongoing clinical studies trials as well as data in countries where it has been approved.

"Based on the totality of the information, the benefit-risk profile of AstraZeneca covid-19 vaccine is positive for the proposed indication in adults 18 years and over," the agency said in information posted online.

"We're starting to get real world evidence. There is evidence that in older age group it would be effective," Sharma said.

Canada has now ordered 22 million doses of the AstraZeneca shot, which was co-developed by researchers at Oxford University. It also will receive up to 1.9 million doses through the global vaccine-sharing initiative known as Covax by the end of June.

Trudeau said 2 million of those doses will come from the Serum Institute of India, which Sharma said uses the same recipe but a slightly different method and also was approved.

The AstraZeneca vaccine has already been authorized in more than 50 countries. It is cheaper and easier to handle than the Pfizer-BioNTech vaccine, which needs deep-cold storage that is not widespread in many developing nations. Both vaccines require two shots, given weeks apart.

Information for this article was contributed by Lauran Neergaard, Matthew Perrone, Carla K. Johnson, Ricardo Alonso-Zaldivar and Rob Gillies of The Associated Press; and by Sheryl Gay Stolberg of The New York Times.

FILE - In this Feb. 10, 2021, file photo, a man receives a COVID-19 vaccine at the Martin Luther King Senior Center in North Las Vegas. The nation is poised to get a third vaccine against COVID-19, but health officials are concerned that at first glance the Johnson & Johnson shot may not be seen as equal to other options from Pfizer and Moderna. (AP Photo/John Locher, File)
FILE - In this Feb. 10, 2021, file photo, a man receives a COVID-19 vaccine at the Martin Luther King Senior Center in North Las Vegas. The nation is poised to get a third vaccine against COVID-19, but health officials are concerned that at first glance the Johnson & Johnson shot may not be seen as equal to other options from Pfizer and Moderna. (AP Photo/John Locher, File)
FILE - In this Feb. 25, 2021, file photo, vials for the Moderna and Pfizer COVID-19 vaccines are displayed on a tray at a clinic set up by the New Hampshire National Guard in the parking lot of Exeter, N.H., High School. The nation is poised to get a third vaccine against COVID-19, but health officials are concerned that at first glance the Johnson & Johnson shot may not be seen as equal to other options from Pfizer and Moderna. (AP Photo/Charles Krupa, File)
FILE - In this Feb. 25, 2021, file photo, vials for the Moderna and Pfizer COVID-19 vaccines are displayed on a tray at a clinic set up by the New Hampshire National Guard in the parking lot of Exeter, N.H., High School. The nation is poised to get a third vaccine against COVID-19, but health officials are concerned that at first glance the Johnson & Johnson shot may not be seen as equal to other options from Pfizer and Moderna. (AP Photo/Charles Krupa, File)
FILE - This September 2020, file photo provided by Johnson & Johnson shows a pharmacist preparing to give an experimental COVID-19 vaccine. The nation is poised to get a third vaccine against COVID-19, but health officials are concerned that at first glance the Johnson & Johnson shot may not be seen as equal to other options from Pfizer and Moderna. (Johnson & Johnson via AP, File)
FILE - This September 2020, file photo provided by Johnson & Johnson shows a pharmacist preparing to give an experimental COVID-19 vaccine. The nation is poised to get a third vaccine against COVID-19, but health officials are concerned that at first glance the Johnson & Johnson shot may not be seen as equal to other options from Pfizer and Moderna. (Johnson & Johnson via AP, File)
This Dec. 2, 2020 photo provided by Johnson & Johnson shows vials of the COVID-19 vaccine in the United States. The nation is poised to get a third vaccine against COVID-19, but health officials are concerned that at first glance the Johnson & Johnson shot may not be seen as equal to other options from Pfizer and Moderna. (Johnson & Johnson via AP)
This Dec. 2, 2020 photo provided by Johnson & Johnson shows vials of the COVID-19 vaccine in the United States. The nation is poised to get a third vaccine against COVID-19, but health officials are concerned that at first glance the Johnson & Johnson shot may not be seen as equal to other options from Pfizer and Moderna. (Johnson & Johnson via AP)
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