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 medic prepares a dose of the Pfizer/BioNTech Covid-19 vaccine at the Maccabi Healthcare Services in Tel Aviv, Israel, on June 6.

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 delivers remarks at a vaccine mobilization event at the TCF Center in Detroit, Michigan, on July 12.

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.

A member of the Philadelphia Fire Department prepares a dose of the Johnson & Johnson COVID-19 vaccine at a vaccination site setup in Philadelphia on March 26.

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.”

A member of the National Guard checks on people after they received a Covid-19 vaccine at the Atlantic County vaccination megasite in Atlantic City, New Jersey, on April 8.

Gov. Phil Murphy announced today that to date, more than 5 million New Jersey residents have been fully vaccinated against Covid-19.

Speaking at a coronavirus press briefing on Monday afternoon, Murphy urged residents to continue getting vaccinated to protect themselves against the Delta variant.

Murphy, accompanied by New Jersey Secretary of Higher Education Brian Bridges, also announced $30 million in federal support for the state’s institutions of higher education to help recover from the virus’ impact and aid the students most affected.

“We know that Covid-19 has exacerbated preexisting racial equity gaps,” said Bridges. “We owe it to students most negatively impacted – in particular, low income, minority, and underserved students … to ensure all students are supported.”

The money will go toward implementing best practices to increase college completion as well as address student food insecurity at 30 colleges across the state.

Vermont currently leads the nation with two-thirds of residents fully vaccinated (66.5%), according to the latest data published Monday by the US Centers for Disease Control and Prevention.

So far, 20 states have fully vaccinated more than half of their residents: California, Colorado, Connecticut, Delaware, Hawaii, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Rhode Island, Vermont, Virginia, Washington and Wisconsin, as well as Washington, DC.

About 48% of the US population is fully vaccinated (159,499,224 people).

A dose is drawn from a vial of the Johnson & Johnson COVID-19 vaccine on March 6 in Thornton, Colorado.

Federal health officials are investigating the possibility that Johnson & Johnson’s coronavirus vaccine might slightly raise the risk of a rare neurological complication known as Guillain-Barré syndrome, a spokesperson from the US Centers for Disease Control and Prevention said in a statement to CNN on Monday.

But even if the vaccine does raise the risk, it’s still better to get vaccinated, the CDC stressed.

“CDC and FDA are monitoring reports of Guillain-Barré Syndrome (GBS) after receiving Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 Vaccine,” the spokesperson said.

“Reports of GBS after receipt of the J&J/Janssen COVID-19 Vaccine in the Vaccine Adverse Event Reporting System (VAERS) are rare, but do likely indicate a small possible risk of this side effect following this vaccine. Around 100 preliminary reports of GBS have been detected in VAERS after 12.8 million doses of J&J/Janssen COVID-19 Vaccine administered. These cases have largely been reported about two weeks after vaccination and mostly in males, many aged 50 years and older.”

The same pattern is not seen with the other two vaccines authorized in the United States, made by Moderna and Pfizer. The spokesperson said the CDC’s Advisory Committee on Immunization Practices would discuss the matter in an upcoming meeting.

“In the United States, nearly all COVID-19 hospitalizations and deaths are now occurring in unvaccinated people. The risk of severe adverse events after COVID-19 vaccination remains rare. Everyone age 12 years and older is recommended to receive a COVID-19 vaccine,” the statement added.

The CDC and FDA briefly paused use of the Johnson & Johnson vaccine earlier this year because of a risk of a rare type of blood clotting complication, but they lifted the pause in April after determining the risk was low and the condition was treatable. The vaccine’s label was updated to warn about the risk.

The Washington Post reported on Monday that the US Food and Drug Administration is preparing to announce a new warning for the Johnson & Johnson coronavirus that links it to Guillain-Barré syndrome.

CNN has reached out to Johnson & Johnson and the FDA for comment.

A nurse prepares a shot of BioNTech Comirnaty vaccine on June 29 at Republique square in Paris.

France will introduce mandatory Covid-19 vaccination for healthcare workers, French President Emmanuel Macron announced on Monday evening in a televised address. 

The measure was announced in a bid to speed up the country’s vaccination campaign as the Delta variant takes hold in France.

But “we have a key asset, which changes everything compared to the previous waves: the vaccine,” Macron explained.

Healthcare workers, workers in care homes and people working in contact with fragile people will have to be vaccinated by Sept. 15, Macron announced. 

“We must aim to vaccinate all French people, because it is the only way to resume normal life,” Macron said.

Macron also encouraged the wider French population to get vaccinated, arguing that “we are a great nation, a nation of science, of the Enlightenments, of Pasteur, so, when science offers us the means to protect ourselves, we must use them, and have trust in reason and progress.” 

Macron said that the question of mandatory vaccination for the whole population may need to be considered but said he “chose trust, and solemnly calls on all unvaccinated citizen to go get vaccinated as quickly as possible.”

Some more context: Overall, more than 35 million people have received at least one dose of a Covid vaccine (53.1% of total population) and at least 27,385,182 are fully vaccinated (40.6% of the total population), according to numbers published by the national health agency on Sunday.

The briefing between Pfizer and federal health officials is scheduled to take place virtually at 5 p.m. ET, per two officials familiar with the schedule. 

CNN reported earlier that Pfizer will 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/BioNTech said they are seeing waning immunity among people who received their vaccine, and reiterated their expectations that people might need boosters in six months to a year. The company also 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.

World Health Organization leaders asked wealthy countries on Monday to hold off on giving booster doses of coronavirus vaccines to their residents before people in other countries can even get their first doses.

“Some countries and regions are actually ordering millions of booster doses before other countries have had supplies to vaccinate their health workers and most vulnerable,” WHO Director-General Dr. Tedros Adhanom Ghebreyesus said during a media briefing.

Tedros said vaccine access isn’t always a question of ability to pay, and many under-vaccinated countries are willing to pay for doses as long as they can get them. 

“When we say share, it’s not like giving it for free. I can bring you a long list of countries that are saying ‘We have money. Where can we buy the vaccines? Just give us the vaccines. We can pay for it,’” Tedros said.

“It’s becoming a two-tier system,” Tedros added. “That is dangerous. You have seen it, and everybody’s seeing it now — high income countries are starting to say, ‘We have managed to control it. It’s not our problem.’”

 Dr. Michael Ryan, Executive Director with the WHO Health Emergencies Program, agreed.

“We need to decide what our priority is, and what part of ‘this is a global crisis,’ are we not getting? This is still a global crisis,” Ryan told the briefing. “If we move on to other matters,” he said, “I think we will look back in anger, and we will look back and shame,” he added.

“There’s some people who want to have their cake and eat it, then they make some more cake, and they want to eat that as well.” 

WHO Chief Scientist Dr. Soumya Swaminathan said data do not yet support the use of booster vaccines or vaccine mixing, and that decisions about boosters should be led by research.

“It will be a chaotic situation in countries if citizens start deciding when and who should be taking a second or a third or fourth dose,” she said. 

More on the possible boosters: Last week, Pfizer/BioNTech said they are seeing waning immunity among people who received their vaccine and said they are picking up efforts to develop a booster dose that will protect people from variants. But in an unusual move, two top federal agencies — the FDA and the US Centers for Disease Control and Prevention — said Americans don’t need boosters yet and said it was not up to companies alone to decide when they might be needed.

Pfizer will virtually brief US government officials today about the potential need for booster shots of its Covid-19 vaccine.

White House press secretary Jen Psaki speaks during a press briefing at the White House on July 12 in Washington, DC.

White House press secretary Jen Psaki on Monday would not say whether the administration expects to reach any clarity during an upcoming meeting with Pfizer officials over whether to recommend a Covid-19 booster shot. 

CNN previously reported that Pfizer will virtually brief US government officials Monday evening regarding the potential need for booster shots of its Covid-19 vaccine, a company spokesperson and two administration officials confirmed. 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.

“We don’t see it as a disagreement, per se. But we provide public health information and make determinations on a large swath of data, and that relates to booster shots as well,” Psaki told reporters during the briefing. “And some of that information that the FDA and the CDC look at – and this was in their statement last week – does include some private sector data, and that can be part of how they assess what recommendations will be, but it’s a much broader swath of information and data than that.”

Last week, Pfizer/BioNTech said they are seeing waning immunity among people who received their vaccine and reiterated their expectations that people might need boosters in six months to a year. The company also said it would seek emergency use authorization for a booster from the US Food and Drug Administration in August. But some experts have argued the data is showing boosters are not necessary yet.

“Now, data – we continue to analyze. Science evolves. And we have long said that we will reserve options, optionality, including how we’re purchasing doses of vaccines to ensure we have maximum optionality for our own – the American public. But any assessment would be made by the CDC and the FDA and we made clear last week that wasn’t a recommendation being made at this time,” she continued.

Psaki also said assessments may be made about specific swaths of the population, suggesting public health recommendations “may not be all or nothing.”

“If they make a conclusion that booster shots are recommended, we’ll provide that information publicly and based on a large range of data and information,” Psaki said, adding that recommendations are “not based on solely the information or data from one company.”

She would not say if any other companies making Covid-19 vaccines have raised the possibility of a booster shot with the administration.

Pedestrians wear face masks while walking down a street in London, on July 4.

UK Prime Minister Boris Johnson confirmed most of the remaining coronavirus restrictions will be lifted in England on July 19.

Johnson said the “single most crucial thing is you get that jab” as he warned “this pandemic is not over” and said life will not simply revert back to how it was before Covid-19.

However, despite rising Covid-19 infections due to the Delta variant, Johnson said the government will stick to its plan to lift restrictions on social contact on July 19.

It will also remove its mask mandate but Johnson said “we expect people to wear a face covering in crowded and closed spaces,” such as on public transport.

He said the government will keep its “tough border policy” and test, trace and isolate system.

People leave cafes and restaurants at midnight on July 10, at the start of the newly implemented curfew in Netherlands.

European leaders are renewing calls for citizens to get vaccinated and reimposing coronavirus restrictions as the more transmissible Delta variant takes hold in Europe.

“The currently observed and predicted continuing deterioration of the epidemiological situation in many countries is expected, given the rapid increase in the Delta variant,” the European Centre for Disease Prevention and Control (ECDC) explained in its latest Covid-19 overview published on Friday.

In June, the ECDC warned the Delta variant would represent about 90% of Covid-19 cases in the European Union by the end of August and emphasized the importance to “progress with the vaccine rollout at a very high pace.”

Around Europe, some leaders are now reimposing measures to fight the pandemi:

Meanwhile, in the UK, Prime Minister Boris Johnson is set to announce England will lift most of its final coronavirus restrictions next week— despite rising infections — due to the success of the country’s vaccination program. More than 87% of people have had a first dose and 66% have had two doses. The UK’s Health Secretary Sajid Javid said Monday the country could see 100,000 cases a day by the end of the summer due to the Delta variant but the government is confident the vaccine “wall” the country has built up will prevent a wave of deaths and the country’s healthcare system from being overwhelmed with hospitalizations.

The UK recorded 34,471 new cases and 6 deaths on Monday, according to the government’s dashboard.

People walk by an AMC movie theater in Times Square on June 8, in New York City.

AMC Theatres says 3.2 million people visited their theaters globally over this past weekend, from Thursday through Sunday. AMC says it was the busiest weekend since its theaters closed in March 2020 because of the pandemic.

In a release, AMC says for the third time since Memorial Day weekend and the second time in two weeks, AMC set another record for “post-reopening weekend attendance in the United States and globally.”

The biggest movie theater chain in the world says the industry box office was led by Disney’s Black Widow starring Scarlett Johansson, which brought in an estimated $80 million in its North America opening this weekend. 

AMC says nine other movies also posted “meaningful ticket sales and helped give the industry its first $100 million plus domestic box office weekend since early 2020.”

More than half of people in the United States who have not received a Covid-19 vaccine – more than 16 million people – live in a household with an annual income of less than $50,000, according to survey data from the US Census Bureau.

However, among those who have not yet been vaccinated, people who live in households with higher incomes were more likely to say that they “definitely” or “probably” will not get a Covid-19 vaccine, while those who live in households with lower incomes were more likely to say that they “definitely” or “probably” will get a Covid-19 vaccine.

Here’s the breakdown of those who have not yet been vaccinated:

Among those who have not been vaccinated, more than half cited concerns about possible side effects as a reason to not get vaccinated, according to the Census survey data. This was the most common reason for not getting a Covid-19 vaccine among all income brackets, but people living in households with higher incomes were more likely to say that they don’t trust the government or don’t believe they need a vaccine. Less than 2% of respondents in all income brackets said that they were concerned about the cost of the vaccine.

The latest data from the Census Bureau’s Household Pulse Survey was collected between June 9 and 21.

Median US household income was $68,700 in 2019, the highest since 1967, according to inflation-adjusted data released by the Census Bureau last year. But remember: those gains were upended by the coronavirus pandemic, which resulted in the steepest decline in employment on record.