The latest on the Covid-19 pandemic in the US

By Melissa Mahtani, Melissa Macaya and Veronica Rocha, CNN

Updated 8:00 p.m. ET, September 17, 2021
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2:26 p.m. ET, September 17, 2021

CDC urges local and state health officials to wait to administer boosters until FDA and CDC sign off

From CNN’s Nadia Kounang

The US Centers for Disease Control and Prevention is urging state and local health officials to wait to administer vaccine booster doses until after the US Food and Drug Administration has OK’d them and the CDC has recommended how to use them.

In a letter sent Thursday and obtained by CNN, the CDC said the Biden administration has been making preparations to begin a Covid-19 booster shot rollout as early as the week of Sept. 20, but “any implementation of booster programs should begin after FDA takes a regulatory action and ACIP and CDC make clinical recommendations for use.”

The FDA’s vaccine advisers are meeting about boosters for Pfizer’s Covid-19 vaccine today, and the CDC’s Advisory Committee on Immunization Practices is scheduled to meet about boosters on Sept. 22-23.

The Pfizer/BioNTech Covid-19 vaccine is already approved by the FDA, and third doses have already been authorized for people who are immunocompromised. 

State health officials told CNN this week there was some confusion about rolling out boosters, but health officials are already preparing to administer them to eligible people as early as next week.

1:18 p.m. ET, September 17, 2021

Biden officials say Covid-19 vaccine booster plan was rolled out for transparency and planning

From CNN’s Betsy Klein

Biden administration officials defended the controversial announcement by the White House in which it said it was preparing to roll out booster Covid-19 shots for most Americans by Sept. 20 – well ahead of any consideration by the US Food and Drug Administration and the US Centers for Disease Control and Prevention – saying they were just trying to plan ahead.

The announcement prompted a flurry of criticism from health experts, including former FDA officials, who have told CNN it was unhelpful and unseemly for the White House to make such an announcement ahead of the regulators who are tasked with such decisions.

Vaccine advisers to the FDA are meeting today to discuss the question of giving booster shots.

“Let me go back to why we made the announcement in August that we did. There were two reasons: transparency and planning,” US Surgeon General Dr. Vivek Murthy told reporters Friday.

Scientific leaders in the administration, Murthy said, “had said publicly that we were following the data closely, and if we saw a signal that indicated to us that protection was starting to wane, and that additional shots may be required, that we would be transparent and open with the public about that. That was one of the reasons we felt it was important to speak up when we saw that signal in the data.” 

“The second reason is planning, you know, if you want to roll out booster shots to the population, you can't flip a switch and make that happen overnight. There’s important planning that has to take place with localities, with state governments, with community organizations. And so we laid out an initial plan for that purpose: to allow the time that we’ve now been using for the last few weeks to do that all-important coordination so the public can be confident that, if and when boosters were required, they would be there for them,” he continued.

Murthy noted that administration officials have always been clear that the plan “would be contingent on the FDA and the CDC’s independent evaluation” and that they will follow that evaluation and the recommendations. 

White House Covid-19 response coordinator Jeff Zients suggested that the decision to announce the plan publicly was made with the hindsight from the previous administration’s handling of vaccine emergency use authorization last year.

“In December, when the vaccines were initially authorized for emergency use, there was not a strong plan in place, and we saw that there was a lag in terms of getting shots in arms. So we want to make sure we're ready, whatever decision the agencies make,” Zients said. 

As CNN’s Elizabeth Cohen has reported, Friday’s scientific back and forth is happening against the backdrop of friction between members of the FDA’s vaccines advisers and the Biden administration. Advisers to the FDA told CNN they're upset that Biden announced a booster program before government scientists reviewed the data.

1:21 p.m. ET, September 17, 2021

CDC-led study finds Moderna Covid-19 vaccine most effective, but Pfizer and J&J shots also protect well

From CNN's Maggie Fox

Moderna vaccine vials are seen at a mass Covid-19 vaccination event on September 15 in Dusun Bambu, Indonesia.
Moderna vaccine vials are seen at a mass Covid-19 vaccination event on September 15 in Dusun Bambu, Indonesia. (Algi Febri Sugita/SOPA Images/LightRocket/Getty Images)

A head-to-head study of all three authorized coronavirus vaccines in the United States finds the Moderna vaccine is slightly more effective than Pfizer’s in real-life use in keeping people out of the hospital, and Johnson & Johnson’s Janssen vaccine comes in third, but still providing 71% protection.

Pfizer’s vaccine provided 88% protection against hospitalization, and Moderna’s was 93% effective.

The US Centers for Disease Control and Prevention led a nationwide study of vaccination involving more than 3,600 adults hospitalized for Covid-19 between March and August.

“Among U.S. adults without immunocompromising conditions, vaccine effectiveness against COVID-19 hospitalization during March 11–August 15, 2021, was higher for the Moderna vaccine (93%) than the Pfizer-BioNTech vaccine (88%) and the Janssen vaccine (71%),” the team wrote in the CDC’s weekly report on death and disease, the MMWR.

“Although these real-world data suggest some variation in levels of protection by vaccine, all FDA-approved or authorized COVID-19 vaccines provide substantial protection against COVID-19 hospitalization.”

They found that the biggest difference between the vaccine made by Moderna and Pfizer/BioNtech’s vaccine was driven by a decline that started about four months after people were fully vaccinated with Pfizer’s vaccine.

“Differences in vaccine effectiveness between the Moderna and Pfizer-BioNTech vaccine might be due to higher mRNA content in the Moderna vaccine, differences in timing between doses (3 weeks for Pfizer-BioNTech versus 4 weeks for Moderna), or possible differences between groups that received each vaccine that were not accounted for in the analysis,” the team wrote.

“A single dose of the Janssen viral vector vaccine had comparatively lower anti-SARS-CoV-2 antibody response and vaccine effectiveness against COVID-19 hospitalizations,” they added. “Understanding differences in vaccine effectiveness by vaccine product can guide individual choices and policy recommendations regarding vaccine boosters. All FDA-approved or authorized COVID-19 vaccines provide substantial protection against COVID-19 hospitalization.”

CDC worked with researchers across the country to study 3,689 patients at 21 hospitals in 18 states for the study. They also looked at antibodies in the blood of 100 healthy volunteers after they’d been vaccinated with one of the three available vaccines.

The news comes as vaccine advisers to the US Food and Drug Administration meet Friday to discuss whether many Americans need to start getting booster doses of coronavirus vaccine.

12:39 p.m. ET, September 17, 2021

FDA vaccine advisers reconvene for public hearing

From CNN's Jacqueline Howard

After taking a 15-minute break, the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC) has resumed its meeting with an open public hearing.

The hearing is scheduled for one hour.

12:33 p.m. ET, September 17, 2021

"Vaccination requirements work," White House says

From CNN’s Betsy Klein

White House Covid-19 response coordinator Jeff Zients, center, speaks at a briefing on September 17.
White House Covid-19 response coordinator Jeff Zients, center, speaks at a briefing on September 17. (White House)

The White House touted the efficacy of vaccination requirements both in increasing vaccinations and boosting economic growth Friday. 

“Vaccination requirements work. And they're good for the economy,” White House Covid-19 response coordinator Jeff Zients said. He went on to highlight a few examples, including a jump from 59% to 90% since United Airlines imposed its own mandate six weeks ago, and success in getting first shots to 89% of US active duty troops, up from 76% three weeks ago.  

The White House is still working to put the new mandates Biden announced last week into effect, and the Labor Department is still writing the rule requiring large employers to require vaccinations among employees. Many businesses have voiced support but some have been skeptical. 

“Vaccination requirements work. They get more Americans vaccinated, which is the best path out of the pandemic. Plain and simple, private and public sectors implementing vaccination requirements have seen their vaccination rates increased by double digits in just a few weeks. And early adopters of vaccination requirements from private employers to healthcare systems to the military have already reached vaccination rates of about 90%, well ahead of the deadlines they've set,” Zients said. 

He went on to tie vaccination rate increases to US economic recovery. 

“By increasing the number of workers that are vaccinated, vaccination requirements will keep workplaces safe and help curb the spread of the virus in communities. That means more Americans getting back to work. It means safer schools and healthier families. It means more consumers dining out and shopping at their local small businesses. Look, you don't have to be an economist to understand why vaccination requirements will boost more than vaccination rates. They will also boost job growth, the labor market, and the overall economy,” he continued. 

Zients also made an appeal for businesses, colleges, healthcare systems, and venues that do not yet have vaccination requirements to “step up and do your part.”

“It’s the right thing to do. You have the power to save lives and help accelerate our path out of this pandemic,” he said. 

Earlier this week, Biden hosted a group of business leaders to highlight support for his administration’s measures. 

12:21 p.m. ET, September 17, 2021

FDA vaccine advisers are taking a 15-minute break

From CNN's Maggie Fox, Jamie Gumbrecht and Jacqueline Howard

The Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC) is taking a break until the open public hearing portion of the meeting, which begins at 12:30 p.m. ET.

The committee started meeting Friday morning to discuss whether many Americans need to start getting booster doses of coronavirus vaccine.

The meeting has been packed with presentations, including from Pfizer/BioNTech, which is arguing that there's enough evidence of waning immunity to justify giving booster doses to people. The FDA will present its own take on the data that's been sent to the agency so far — although written briefing materials published before the meeting suggest the agency is remaining neutral for the time being.

The meeting, which will be streamed online, is expected to last until 4:45 p.m. ET or later, with a period for discussion and vote scheduled to start at 2:25 p.m. ET and to last at least two hours.

12:13 p.m. ET, September 17, 2021

Covid-19 booster doses have similar safety profile as first and second doses, Israeli health official says

From CNN's Jacqueline Howard

Covid-19 booster doses appear to have no additional adverse events or safety concerns compared with the first and second doses of vaccine, according to data from Israel.

"We didn't see any new types of adverse events and the rate, to be modest, is at least the same if not lower," Dr. Sharon Elroy-Preiss, director of public health services at Israel's Ministry of Health, told the US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC) in a meeting Friday.

The committee is meeting to discuss Pfizer/BioNTech's application for the administration of a booster dose of its Covid-19 vaccine in the United States.

Among more than 2.8 million booster doses administered in Israel, there were 1,328 non-serious adverse events reported and only 19 serious reports following that third dose, according to the safety data that Elroy-Preiss presented in Friday's meeting.

Seven of the serious adverse events were in people ages 12 to 64. Two were allergic reactions. There was one case of myocarditis that is still under investigation and a case of Guillain-Barré syndrome that could be possibly associated with the vaccine.

The other events, which included blood clots, had no causality connected to the vaccine, according to the data. The remaining serious reports were in people ages 65 and older and included encephalitis and hemorrhage with possible connections to the vaccine. The rest of the serious events had no causality tied to the vaccine, the data showed.

Overall, "if we look at local adverse events, we would still see sort of the same trend. We don't see any new adverse events. We know that there's more lymphadenopathy, but we're not seeing any new adverse events and the rate is smaller," Elroy-Preiss said, adding that she is presenting the data with caution. Lymphadenopathy is swollen lymph nodes.

She noted that the risk of myocarditis — inflammation of the heart — is small, and far higher from coronavirus itself than from the vaccine. Almost all the vaccine-linked myocarditis cases in Israel were not severe, she said.

12:11 p.m. ET, September 17, 2021

WHO reiterates call for wealthy nations to wait on Covid-19 boosters

Tedros Adhanom Ghebreyesus, director-general of the World Health Organization, attends a conference in Geneva, Switzerland, on September 13.
Tedros Adhanom Ghebreyesus, director-general of the World Health Organization, attends a conference in Geneva, Switzerland, on September 13. (Fabrice Coffrini/AFP/Getty Images)

WHO Director-General Tedros Adhanom Ghebreyesus reiterated his call last week for wealthy nations to refrain from boosting their Covid-19 vaccinations until shots are available to more of the world.

In a media briefing on Sept. 8, he urged countries to wait until at least the end of the year – a longer timeline than WHO's initial call to wait till the end of September.

"A month ago, I called for a global moratorium on booster doses at least until the end of September, to prioritize vaccinating the most at-risk people around the world who are yet to receive their first dose. There has been little change in the global situation since then, so today I am calling for an extension of the moratorium until at least the end of the year, to enable every country to vaccinate at least 40% of its population," Tedros said.

"Low and lower-middle income countries are not the second or third priority. Their health workers, older people, and other at risk groups have the same right to be protected," he continued said.

"I will not stay silent when the companies and countries that control the global supply of vaccines think the world's poor should be satisfied with leftovers."

"As the world’s largest producers, consumers and donors of vaccines, the world’s 20 leading economies hold the key to vaccine equity and ending the pandemic. Now is the time for true leadership, not empty promises," Tedros said.

White House press secretary Jen Psaki has reiterated the Biden administration's view that the US can offer Covid-19 booster shots to Americans this fall while at the same time working to provide vaccines to people around the world who have not yet received a shot.

"Our view is that this is a false choice," Psaki told reporters at a White House briefing last week. "And the United States has donated and shared about 140 million doses with over 90 countries – more than all other countries combined."

12:26 p.m. ET, September 17, 2021

Fauci says he thinks data "strongly suggests" a third Covid-19 vaccine dose will be approved

From CNN's Virginia Langmaid

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, speaks during a hearing in Washington, DC, on May 11.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, speaks during a hearing in Washington, DC, on May 11. (Greg Nash/Pool/AFP/Getty Images)

Data shared ahead of key Covid-19 vaccine booster decisions supports moving forward with an additional dose of a Covid-19 vaccine for many people, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told MSNBC on Friday. 

“Are you expecting Pfizer booster shots to be approved?” MSNBC’s Craig Melvin asked Fauci.

“I don't want to get ahead of the FDA deliberations. The data that I've seen, I believe, strongly suggests that that will be the case,” Fauci said. 

The Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee is meeting Friday to review data on a potential third dose of Pfizer/BioNTech’s Covid-19 vaccine.

“The FDA, with their advisory group, the VRBPAC, will very carefully look at every single piece of data and make that determination. So, you know, rather than get ahead of them, our position about at least planning for the evaluation that we might have to give boosters we certainly have planned and are ready to go pending the decision that's made from a regulatory standpoint, by the FDA and their advisers,” Fauci said.