April 13 coronavirus news

A decision on whether to extend emergency use of the Pfizer/BioNTech Covid-19 vaccine to people ages 12 to 15 could be made in “a couple of weeks,” Dr. Peter Marks, director of the US Food and Drug Administration's Center for Biologics Evaluation and Research, said Tuesday. 

Pfizer recently asked the FDA to expand the emergency use authorization of the vaccine to include people ages 12 to 15 years.

“Obviously we feel a sense of urgency of getting through these, and we'll do our best to be reviewing this,” Marks said in a webinar hosted by the American Medical Association. “If we can get down to age 12, we can get junior high and high school kids with a good vaccination campaign back to school, hopefully in the fall.”

Right now, the emergency use authorization for the Pfizer vaccine is for people 16 and older.

The interruption of the Johnson & Johnson vaccination could have a significant impact on college students, who were key targets for getting one shot before leaving school at the end of the spring semester.

While the White House downplayed the significance of the Johnson & Johnson pause, saying the Moderna and Pfizer vaccines were the predominant vaccinations being offered, officials in two states tell CNN that the fallout on college campuses was concerning. 

“There isn’t enough time to give two shots before many students leave for the summer,” according to one state official in Ohio, where Gov. Mike DeWine had been touting the Johnson & Johnson vaccination for college students. “This is a far bigger deal than the White House will acknowledge.” 

An official in another Midwestern state also said Tuesday that college campuses had been planning vaccination clinics for students in the remaining two weeks of April. The pause on the Johnson & Johnson vaccination makes those plans highly uncertain, the official said, depending on how long the interruption takes place.

The CDC and the US Food and Drug Administration have recommended that the United States pause the use of the Johnson & Johnson vaccine until the review is complete.

Johnson & Johnson has decided to pause vaccinations in all of its clinical trials while they “update guidance for investigators and participants,” according to a statement from the company on Tuesday.

The announcement follows a recommendation from US Centers for Disease Control and Prevention and the US Food and Drug Administration to pause the use of the Johnson & Johnson vaccine over blood clot concerns out of an “abundance of caution.”

The company also announced earlier that it would “proactively delay the rollout of our vaccine in Europe.”

The company currently has several ongoing trials including an ongoing Phase 2a trial and a Phase 3b trial in South Africa.

The Phase 2a trial has been ongoing since September and was initially designed to study single-dose and two-dose regimens of the vaccine, at different dose levels and schedules, in healthy adults ages 18 to 55 and 65 and older. The study expanded this study to adolescents age 12 to 17 on April 2.

Though the cases of severe blood clots after vaccination with Johnson & Johnson’s Covid-19 vaccine were among women, men who received the vaccine should also watch carefully for symptoms of adverse events, Dr. Peter Marks, director of the US Food and Drug Administration's Center for Biologics Evaluation and Research, said Tuesday.

The US Centers for Disease Control and Prevention and FDA has recommended a pause on use of Johnson & Johnson's coronavirus vaccine, following six reported US cases of a rare and severe type of blood clot.

“My plea is don't dismiss a male who says, ‘I got Janssen a week ago, and I have a headache that's nothing like I've ever had before and I'm not quite feeling myself – that person probably should be evaluated,” Marks said in a webinar hosted by the American Medical Association.

Marks noted that the one case of this rare clotting event observed in the clinical trial was in a man.

“There was one instance of cerebral vein thrombosis with thrombocytopenia in the clinical trial – so that's one in 20,000, approximately with Janssen – and that was in a man.”

The Moderna Covid-19 vaccine remains more than 90% effective for at least six months, the company announced in a statement Tuesday.

Moderna cited preliminary results from its Phase Three trial showing the vaccine has been more than 90% effective against all cases of the virus and more than 95% effective against severe disease.

Research published recently in The New England Journal of Medicine showed robust antibody levels in people vaccinated with Moderna’s vaccine six months out.

Pfizer has boosted production of its Covid-19 vaccine and “can deliver 10% more doses to the US by the end of May than previously agreed,” Pfizer CEO Dr. Albert Bourla said in a tweet Tuesday.

This means the company will deliver 220 million doses by the end of next month – 20 million more than previously expected. The company had previously expected to fulfill its US contract for 300 million doses by the end of July. Bourla said the company would also hit that deadline two weeks early.  

The US has purchased 300 million doses from Moderna, as well. In a statement Tuesday, Moderna noted it “remains on track to deliver the second 100 million doses to the U.S. government by end of May 2021 followed by another 100 million additional doses by end of July 2021.”

Protection from mRNA Covid-19 vaccines likely lasts at least nine months, Dr. Peter Marks, director of the US Food and Drug Administration's Center for Biologics Evaluation and Research, said Tuesday.

Current research on mRNA Covid-19 vaccines has shown that the vaccines likely provide protection for at least six months.

“We're believing that it's probably going to last at least nine months, but we're going to be checking this,” Marks said in a webinar hosted by the American Medical Association.

Marks said that researchers will need to watch for whether immunity is dropping off more quickly for older and immunocompromised individuals. He added that it is possible the vaccines will require boosters. 

“With each month, we'll get more certainty about when that might be necessary,” said Marks.

Nearly 1,500 virus specimens were collected between March 22 and March 28 and genetically sequenced by the New York City Pandemic Response Laboratory. Of those specimens, about 30% were identified to be B.1.1.7, the variant first identified in the U.K. Another 45% of the genetically sequenced samples were identified to be B.1.526, the variant first discovered in New York City. 

B.1.1.7 is classified as a variant of concern by the US Centers for Disease Control and Prevention, as it has been found to be more transmissible and cause more severe infections. B.1.526 is a variant of interest, with ongoing studies regarding its effects on disease severity and vaccine effectiveness. 

The prevalence of both of these variants has increased quickly in New York City. In the second half of February, B.1.1.7 accounted for about 10% of genetically sequenced specimens and B.1.526 accounted for about 35% of those sampled. 

About 5% of confirmed cases have been genetically sequenced, and both B.1.1.7 and B.1.526 have been identified in all five of the city’s boroughs, according to the city’s health department. 

“The proportion of variants of concern and variants of interest is increasing,” according to the report, suggesting that the “spread of specific variants, potentially due to their greater infectiousness, which is one reason why COVID-19 cases in NYC remain at a high plateau of between 3,000 to 4,000 new cases each day.”

Over the past seven days, New York City has reported more than 15,000 new cases of Covid-19, an improvement from the average of nearly 19,000 cases per week in recent weeks, according to data published by the city’s health department. However, New York City ranks 20th for the most new Covid-19 cases per capita among US metropolitan areas in the past week, according to data the data from the White House Covid-19 Team 

Nationally, B.1.1.7 accounted for about 44% of samples collected between March 14 and March 27 and B.1.526 accounted for about 6% of samples, according to data published by the CDC. 

Children represented 13.5% of all cases in the United States. More than 3.54 million children in the United States have tested positive for Covid-19 as of April 8.

Children made up between 6% and 18.9% of those who were tested for Covid-19, and 5.3% to 32.3% of children tested were positive for the coronavirus, depending on the state.

Children are still considered much less likely than adults to develop severe symptoms of Covid-19 or to die from the disease. Children represented 1.3% to 3.1% of total reported hospitalizations for Covid-19, based on the information provided by 24 states and New York City. Only 0.1% to 1.9% of all cases of Covid-19 in children required hospitalization. 

Ten states reported zero child deaths among the 43 states that provided data on Covid-19 mortality.