July 12 coronavirus news

"Nothing has changed" following Monday’s briefing between Pfizer and federal health officials, according to a person present for the virtual meeting.

It was largely seen as a courtesy after the two sides disagreed on when a booster shot for the coronavirus vaccine might be needed, leading to rare pushback from the US Food and Drug Administration and US Centers for Disease Control and Prevention that fully vaccinated Americans don't need a booster right now. 

Following the meeting, that guidance has not changed. They met for about an hour as Pfizer presented data. 

Separately, a US Department of Health and Human Services spokesperson told CNN: "Health officials are routinely briefed by manufacturers and others on the latest data on COVID-19 vaccines, and today Pfizer offered to brief officials on their latest preliminary data. We appreciate the information they shared, and officials continue to engage in a science-based rigorous process to consider whether, when, or for whom a booster might be necessary."

"As CDC and FDA said last week, this process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies, but does not rely on those data exclusively. At this time, fully vaccinated Americans do not need a booster shot. The vaccines available now offer a very high degree of protection. The administration is prepared for booster doses if and when the science demonstrates that they are needed, and any recommendation by CDC and FDA would come after their thorough review process."

The official added, "Officials will continue to review any new data as it becomes available and will keep the public informed."

Pfizer has called its meeting with US public health officials about the potential need for boosters “productive,” according to a new company statement.

The meeting is seen as a courtesy, and federal guidance on boosters is not expected to change immediately following the meeting, a senior health official said. 

A Pfizer spokesperson told CNN last week that “We regularly discuss our entire research program with regulators and public health authorities in the U.S. and other countries around the world.”

Pfizer emphasized that it will be publishing “more definitive data in a peer-reviewed journal and continuing to work with regulatory authorities to ensure that our vaccine continues to offer the highest degree of protection possible,” according to Monday’s statement.

The briefing between Pfizer and federal health officials has now ended, according to a source familiar with the meeting. 

CNN reported earlier that Pfizer would virtually brief US government officials Monday evening regarding the potential need for booster shots of its Covid-19 vaccine.

The meeting is seen as a courtesy, and federal guidance on boosters is not expected to change immediately following the meeting, a senior health official said.

Last week, Pfizer said it was seeing waning immunity among people who received its vaccine, and reiterated earlier statements saying people might need boosters in six months to a year. They did not provide any data to back that up.

Pfizer said it would seek emergency use authorization for a booster from the US Food and Drug Administration in August. Hours after that announcement, two federal agencies issued a rare joint statement saying that Americans do not yet need booster shots.

The US Food and Drug Administration updated the label for Johnson & Johnson’s coronavirus vaccine Monday, saying there may be an increased risk of a rare neurological condition called Guillain-Barré Syndrome among people who have been recently vaccinated.

The FDA said it was not yet clear if the vaccine causes the condition, but noted an increase in reports of the sometimes paralyzing syndrome. 

“Today, the FDA is announcing revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccine to include information pertaining to an observed increased risk of Guillain-Barré Syndrome (GBS) following vaccination,” it said in a statement sent to CNN.

“Based on an analysis of Vaccine Adverse Event Reporting (VAERS) data, there have been 100 preliminary reports following vaccination with the Janssen vaccine after approximately 12.5 million doses administered,” the FDA said in the statement.

“Of these reports, 95 of them were serious and required hospitalization. There was one reported death. Each year in the United States, an estimated 3,000 to 6,000 people develop GBS. Most people fully recover from the disorder,” the agency added.

But it said the number of reports indicated there could be an increased risk of GBS with the Janssen vaccine.

“Additionally, the Fact Sheet for Recipients and Caregivers notes that vaccine recipients should seek medical attention right away if they develop any of the following symptoms after receiving the Janssen COVID-19 Vaccine: weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading to other parts of the body; difficulty walking; difficulty with facial movements, including speaking, chewing or swallowing; double vision or inability to move eyes; or difficulty with bladder control or bowel function,” the FDA said.

A study done in Israel shows the Pfizer/BioNTech coronavirus vaccine protects pregnant women well from infection.

A head-to head comparison of about 7,500 pregnant women who had been vaccinated to 7,500 similar pregnant women who had not been vaccinated showed the vaccine reduced the risk of infection by about 78%, the team at Israel’s Maccabi Healthcare Services reported in the Journal of the American Medical Association.

While that’s lower efficacy than reported for the general population, the researchers said, the statistics might be skewed because pregnant women in general have been taking more care to avoid infection.

“The benefit from the vaccine may be somewhat attenuated among this population compared with the general public because pregnant women were generally advised to take extra precautions during the pandemic and to maintain particular adherence to social distancing guidelines, regardless of vaccination status. Immunologic response may also be different among pregnant women compared with the general population,” they wrote.

But there are good reasons to vaccinate pregnant women, they said.

“During pregnancy, alterations in hormonal levels and immune system function may increase women's vulnerability to viral infections. Although SARS-CoV-2 infection in pregnant women is mostly asymptomatic or mild, it may result in severe complications, including admission to the intensive care unit and mechanical ventilation, particularly during the third trimester,” they wrote.

“Symptomatic SARS-CoV-2 infections in women also have been linked to a greater likelihood of preterm delivery and fetal intrapartum distress.”

Vice President Kamala Harris hailed Detroit's resilience during the pandemic and made an urgent call for the still hesitant to get vaccinations.

In working to convince vaccine skeptics, Harris said it was important not to appear judgmental: "Let’s not do this in a way where we judge anybody, not looking down on anybody," she said.

Describing her own experience getting a second shot, she said, "I wasn't feeling so well the second day," but said it side-effects only lasted a few hours. 

"That’s part of it. A few hours. It could save your life," she said.

Harris ended by appealing to people's faith, saying, "I do believe the act of getting vaccinated is the very essence of what the Bible tells us when it says love thy neighbor."

She also marked the “incredible” progress the country has made in getting vaccinated but said now is the time to build on that progress and get more people both in Detroit and across the country vaccinated. Last week, the Biden administration officially missed their July Fourth goal to get 70% of Americans partially vaccinated. Harris’ event today served as just one of the administration's recent events looking to get more Americans to get shots in their arms.

“So, I'm here to say, thank you. Congratulations and we have more work to do,” she said.

Harris streamlined the initiatives Biden laid out last week to enable more Americans to get their vaccines, saying it boiled down to two parts: “bringing the facts” and more vaccines. Harris insisted that going door-to-door to provide information was necessary to reach people who were receiving bad information.

"Sadly there’s a lot of misinformation. Let’s know what it is and talk to our neighbors and say these are the facts," she said of the strategy. "Let's take it to the streets, take it to the people."

Harris called the Delta variant "no joke" and noted that most hospitalizations and deaths are currently among people who haven't been vaccinated.

It was a similar stance the speakers who came before Harris, including Detroit Mayor Mike Duggan and Michigan Gov. Gretchen Whitmer, the Delta variant loomed large, and both framed their remarks around the need for more people to get vaccinated to not contract the highly contagious strain.

Vaccine maker Johnson & Johnson confirmed Monday it’s talking to the US Food and Drug Administration about an increase risk of a rare neurological complication among people who received its single-dose Covid-19 vaccine.

“We have been in discussions with the U.S. Food and Drug Administration and other regulators about rare cases of the neurological disorder, Guillain-Barré syndrome, that have been reported following vaccination with the Janssen COVID-19 vaccine,” the company said in a brief statement.

“Any adverse event report about individuals receiving Johnson & Johnson’s single-shot COVID-19 vaccine, as well as our own assessment of the report, is shared with the U.S. Food and Drug Administration, the European Medicines Agency and other appropriate health authorities. We strongly support raising awareness of the signs and symptoms of rare events to ensure they can be quickly identified and effectively treated.”

Earlier Monday, a US Centers for Disease Control and Prevention spokesperson told CNN the agency and the FDA were looking at reports of more cases than expected of Guillain-Barre among people who got the shot.

Over the past week, states that have fully vaccinated more than half of their residents have reported an average Covid-19 case rate that is about a third of that in states that have fully vaccinated less than half of their residents, according to a CNN analysis of data from Johns Hopkins University and the US Centers for Disease Control and Prevention. 

The states that have fully vaccinated more than half of their residents reported an average of 2.8 new Covid-19 cases per 100,000 people each day last week, compared to an average of about 7.8 cases per 100,000 people each day in states that have vaccinated less than half of their residents. 

In the United States overall, the average daily case rate was about 5.9 cases per 100,000 people over the past week, up 47% from the week before, according to JHU data. And 48% of the US population is fully vaccinated, according to the CDC. 

Only four states had more than a 10% decline in Covid-19 cases compared to last week. Among them were Maine and Rhode Island – both of which have fully vaccinated about 60% of their residents.

Vermont leads the nation with about 66% of its population fully vaccinated, and while case rates in the state have increased compared to last week, the state still had the lowest case rate in the country last week, with an average of less than 1 new case per 100,000 people each day. 

Meanwhile, Alabama, Mississippi and Arkansas are the only states to have fully vaccinated less than 35% of their residents. Average daily case rates in each of these states were among the 10 worst in the county last week, each of which increased at least 39% compared to last week. 

Teenagers should be able to get coronavirus vaccines without their parents’ permission – especially if physicians back the decision, a team of health policy specialists argued Monday.

They said older teens, especially, may understand the benefits of vaccination at least as well – and sometimes better than – as their parents do and argued that vaccinating children protects both the children and the population at large.

“In the context of vaccination, some older minors may possess a more accurate understanding of the risks and benefits of a vaccine than their hesitant guardians,” they wrote.

While coronavirus has not been hitting children and teens especially hard, more than 300 US children have died in the pandemic, the experts argued. Plus, they can be a reservoir for continued spread.

“Approximately one-third of confirmed COVID-19 cases in minors have been asymptomatic, creating an opportunity for minors to spread the virus unknowingly,” they wrote, adding, “The reduction of asymptomatic transmission is essential to slowing the spread of the virus, and growing evidence suggests that vaccination provides substantial public health benefits by decreasing transmission in addition to its direct, individual benefits.”

They suggested that healthy children under the age of 12 should still only be vaccinated with the permission of parents or guardians. “Children older than 9 years with underlying medical conditions for whom the vaccine could offer increased benefits, however, would be exempt from this general prohibition and, after an affirmative evaluation of their competency, may consent,” they wrote.

“In such cases, weighing the risk of parental retribution or the loss of the therapeutic relationship against the risk of minors contracting the virus would require a careful case-by-case determination.”

Teens over the age of 15 should be able to give consent for vaccination with no approval needed, they said.

Few states currently authorize vaccination without parental consent, they noted. “In four states, minors can consent to immunizations for sexually transmitted infections, such as human papillomavirus and hepatitis B, without parental permission. In five states, minors are allowed to consent to any medical intervention, including vaccines.”