Kristen Welker and Dareh Gregorian
4h ago / 4:56 PM UTC
FDA chief summoned to White House to defend vaccine timetable
White House chief of staff Mark Meadows summoned FDA Commissioner Stephen Hahn to the West Wing on Tuesday to discuss why his agency hasn’t moved faster to approve Pfizer’s coronavirus vaccine, a source familiar with the matter confirmed to NBC News.
The morning meeting was first reported by Axios, which quoted an unnamed administration official saying, “There are some who are complaining the FDA is not working around the clock to get things approved.”
While President Donald Trump has publicly accused the agency of dragging its feet, Hahn told Axios his team is doing what’s necessary to make sure the vaccine is safe for the general public. “Let me be clear — our career scientists have to make the decision, and they will take the time that’s needed to make the right call on this important decision,” he said.
White House press secretary Kayleigh McEnany was asked about the report in an appearance on Fox News, and at first sidestepped the question. “I don’t want to talk about the meetings that will be going on today in the West Wing, but what I will say is this we are working around the clock,” McEnany said. Pressed further, she said, “This president will never apologize for putting the fire under these agencies to say, yes, we want a safe vaccine, absolutely; we also want a fast one because lives are at stake, and a vaccine by the end of the year is key and paramount.”
Pfizer applied to the FDA for an emergency use authorization for its vaccine on Nov. 20. An FDA spokesperson told Axios that among the reviews they are doing on the vaccine are ensuring that the manufacturing process and controls are appropriate, checking statistical analyses and doing additional analyses to look at the effect of the vaccine on those at greater risk of adverse effects.
5h ago / 3:34 PM UTC
N.J. to limit outdoor gatherings, pause indoor sports
New Jersey is tightening its rules yet again for outdoor gatherings and indoor sports in the wake of climbing coronavirus infection rates in recent weeks.
Beginning next Monday, outdoor gatherings will be limited from 150 people to 25, according to an executive order signed by Gov. Phil Murphy. In addition, indoor practices and competitions for youth and adult sports will be prohibited beginning Saturday through Jan. 2.
The move comes as Murphy tweeted that nearly 70 percent of people in New Jersey reached by contact tracers would not cooperate, while pushing back against social media rumors that he would enforce a full lockdown in the state.
New Jersey’s health department on Monday also said it would issue guidance for public holiday interactions, including for tree and menorah lightings and mall Santa Clauses. Officials said while malls must require appointments, masks, time limits and social distancing for visits, “children should not be permitted to sit on Santa’s lap.”
7h ago / 2:32 PM UTC
November’s Covid-19 tally: 4M cases, 37,000 dead
Covid-19 surged across the country in November infecting 4,389,678 people, more than double October’s figure, according to NBC News’ tally. There were 37,172 reported deaths in the month.
Monday saw 163,873 new infections, about even with the 161,472 cases the country has been averaging the past week, up from an average of 116,046 cases per day four weeks ago.
Several states set single-day records for reported cases and deaths Monday:
- Tennessee reported 7,975 cases.
- Colorado reported 135 deaths, after reporting zero the previous four days.
- Rhode Island reported 2,769 cases, after reporting zero the past two days.
8h ago / 1:26 PM UTC
Moderna and Pfizer-BioNTech ask European regulators for coronavirus vaccine approval
Moderna and Pfizer-BioNTech asked European Union regulators for Covid-19 vaccine fast-track approval Tuesday, but the decision will likely take longer than in the United States.
The E.U.’s European Medicines Agency said it will meet to discuss the Pfizer-BioNTech vaccine by Dec. 29, and Moderna’s by Jan. 12. Regulators at the U.S. Food and Drug Administration are set to meet in mid-December.
After the EMA makes a recommendation, it would then be sent to the European Commission, the E.U.’s executive branch, for fast-tracked approval, before being sent to individual E.U. member countries for final sign-off.
Both Moderna and the Pfizer-BioNTech collaboration asked for something called “conditional market authorization.” This is when there is less data than normal, but the “medicine’s benefits outweigh its risks,” the EMA says. Both vaccine candidates had no serious side effects in their Phase 3 trials, the companies said.
The Associated Press
8h ago / 12:42 PM UTC
Covid restrictions will remain in Philippines through holiday season
MANILA, Philippines — Coronavirus quarantine restrictions will remain imposed in the Philippine capital during the Christmas season this month and officials said they will ban big Christmas parties in Asia’s largest Roman Catholic nation to prevent new infection spikes.
President Rodrigo Duterte said in televised remarks late Monday that aside from Metropolitan Manila, the bustling capital region of more than 12 million, the “general community quarantine” would be imposed in seven other cities and provinces in December.
The restrictions ban large public gatherings, actual school classes and entertainment businesses but allow shopping malls, restaurants and essential shops, including barber shops, to operate with required safeguards, including the wearing of face masks and shields and social distancing.
Duterte lamented that many still defy quarantine restrictions like the wearing of face masks and warned of a possible resurgence of infections like in some Western countries.
“In the Philippines, it’s hard-headedness,” Duterte said.
The Philippines has reported more than 431,600 confirmed coronavirus infections, the second-highest in Southeast Asia, with at least 8,392 deaths.
10h ago / 11:32 AM UTC
When Covid-19 closed schools, Black, Hispanic and poor kids took biggest hit in math, reading
When the Covid-19 pandemic forced the closure of most U.S. schools last spring, students were thrown into new and unfamiliar ways of learning. Special education students and children learning English lost support that their schools struggled to provide online. Many students had no access to computers or internet and were completely cut off from their teachers.
The true toll these disruptions have taken on student learning won’t be known for months or years, but new reports from national education-testing organizations have begun to offer an early look at that impact.
The latest is a report from NWEA, formerly the Northwest Evaluation Association, which analyzed the results of tests given to nearly 4.4 million U.S. students in grades three through eight this fall and found that most fell short in math, scoring an average of 5 to 10 percentile points behind students who took the same test last year.
Pfizer and BioNTech apply for emergency vaccine approval in Europe
BERLIN — German pharmaceutical company BioNTech and its U.S. partner Pfizer say they have submitted an application for conditional approval of their coronavirus vaccine with the European Medicines Agency.
The two companies said Tuesday that the submission, which occurred Monday, completes the rolling review process they initiated with the agency on Oct. 6.
The move comes a day after rival Moderna said it was asking U.S. and European regulators to allow emergency use of its COVID-19 vaccine.
BioNTech said that if the vaccine, currently named BNT162b2, is approved, its use in Europe could begin before the end of 2020.