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Coronavirus Updates: FDA Panel Recommends Moderna Vaccine, Setting Up Formal Authorization On Friday

Elizabeth Kim

Published Dec 17, 2020

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In this photo illustration, a vial and a medical syringe seen displayed in front of the Food and Drug Administration (FDA) of the United States and Moderna biotechnology company's logos.

Pavlo Gonchar/SOPA Images/Shutterstock

Elizabeth Kim

Published Dec 17, 2020

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This is our daily update of breaking COVID-19 news for Thursday, December 17th, 2020. Previous daily updates can be found here, and up-to-date statistics are here.

New York City is in Phase 4 of reopening now, which includes zoos, botanical gardens, museums, and gyms. Citing rising hospitalization rates, Governor Andrew Cuomo suspended indoor dining in NYC starting Monday, December 14th. After being shut down for several weeks, NYC public schools partially reopened on December 7th for 3K-5th grade students, with students with special needs returning on December 10th. Certain parts of Staten Island remain under a zoned shutdown.

Get answers to questions you may have with our "Ask An Epidemiologist" series, or learn more about NYC COVID-19 testing options with our explainer. Here are some local and state hotlines for more information: NYC: 311; NY State Hotline: 888-364-3065; NJ State Hotline: 800-222-1222.

Here's the latest:

6 p.m. An advisory panel for the Food and Drug Administration on Thursday overwhelmingly voted in favor of recommending Moderna's coronavirus vaccine for emergency use authorization, an expected but significant step that could bring millions of urgently needed additional vaccine doses to the country.

“To go from having a sequence of a virus in January to having two vaccines available in December is a remarkable achievement,” said James Hildreth, the president and CEO of Meharry Medical College who was one of the panel members.

More than 300,000 Americans have now died from coronavirus, and several states, including California and New York, are grappling with rising caseloads and hospitalization rates.

Thursday's vote, which consisted of 20 in favor and one abstention, came after a day long meeting. Experts on the panel reviewed the results of trials, which showed the Moderna vaccine to be 95% effective.

If the process unfolds the way it did for Pfizer and BioNTech's vaccine last week, the FDA will likely issue a formal authorization on Friday, enabling shipments to begin this weekend. Last Friday, the Trump administration reportedly pressured FDA officials to expedite their authorization, although the agency head, Dr. Stephen Hahn, denied the stories.

Following the panel's vote, Hahn issued a tweet, recognizing the urgency of the situation.

The Moderna vaccine would be given to people 18 and older, unlike the Pfizer-BioNTech one, which can be administerd to those 16 and older.

In what may be a significant advantage that will aid distribution, the Moderna vaccine can be stored at normal freezer temperatures. The Pfizer-BioNTech vaccine requires ultra cold storage.

New York City has received a total of 42,900 doses of the Pfizer-BioNTech vaccine so far. Including the Moderna vaccine, city officials expect to have a total of 465,000 doses in December.

Vaccinations of hospital workers began this week. Nursing home residents and staff are also expected to be inoculated in the first phase.

NYC Positivity Hits 6% As 11 City Hospitals Cancel Elective Surgeries To Prepare For Surge

Mitchell Katz, head of NYC Health + Hospitals at a recent press briefing in City Hall.

Photographer/Mayoral Photography Office

11:30 a.m. New York City's seven-day average testing positivity rate has now risen to 6%, reflecting increasing coronavirus infections amid the colder weather and holiday season that has drawn more people indoors.

"Six percent is not acceptable. We have a lot of work to do," said Mayor Bill de Blasio, during his Thursday press briefing.

The mayor has warned of broader shutdowns in light of the ongoing crisis. He said he was continuing to have conversations with Governor Andrew Cuomo's office over the timing of the restrictions.

Earlier this week, de Blasio recommended that the shutdowns occur after Christmas. On Thursday, he said that while that period may be a "natural moment," he said he was increasingly concerned about growing caseloads and hospitalizations.

"I don’t like restrictions, nobody likes restrictions, but I think we need them sooner rather than later," he said.

"Something has to be put into effect soon," he added.

Cuomo held a short storm briefing on Thursday morning, and did not address the issue of shutdowns in New York City.

As of Tuesday, all 11 public hospitals have canceled elective surgeries, according to Dr. Mitchell Katz, the head of New York City's Health and Hospital system.

Katz said the city's public hospitals currently have 65% occupancy in both ICU and regular beds. They have already expanded capacity by 25% as mandated by the governor.

One hundred patients have since been transferred between hospitals to ensure that no one hospital is overburdened as Elmhurst hospital was in the spring.

Katz noted that patients with coronavirus being admitted now have not been as sick as they were in the spring, making it easier for hospitals to transfer them if necessary.

In more hopeful news, de Blasio said 5,200 hospital workers in New York City have been vaccinated as of Wednesday. He said he expects the number to ramp up in the coming days.

A total of 42,900 doses of the Pfizer vaccine have arrived so far. New York City expects a total of 465,000 doses in December.

Katz said he expects staffers at all 11 public hospitals will be vaccinated in three weeks.

He added that because of the snowstorm, coronavirus testing was suspended at Health and Hospital sites on Wednesday afternoon.

Testing should resume at all locations between noon and 2 p.m., Katz said. Testing was not interrupted in emergency rooms.

Two Alaska Healthcare Workers Suffer First Known Adverse Reactions To Pfizer Vaccine In U.S.

Dr. Timothy Harkin (L) is inoculated Tuesday with the Covid-19 vaccination by Kelsey Lynch, RN (R) at Mount Sinai Hospital.

JUSTIN LANE/EPA-EFE/Shutterstock

Two health care workers at a hospital in Juneau, Alaska needed treatment for allergic reactions shortly after receiving Pfizer's coronavirus vaccine, marking the first known adverse reactions in the United States.

Early last week, two health care workers in the United Kingdom also experienced severe allergic reactions, which resulted in a slowing down of the rollout there. The U.K. has advised those with a history of significant allergies against receiving the vaccine.

One of the Alaskan hospital staffers was a woman who did not have a history of allergies. She was admitted to an intensive care unit and remained in the hospital Wednesday night.

The other individual experienced "eye puffiness, light-headedness and scratchy throat" 10 minutes after receiving the vaccine Wednesday, according to a statement from Bartlett Regional Hospital.

The Centers for Disease Control and Prevention has recommended that all people receiving the vaccine be observed for 15 minutes.

“We were expecting these things and we had all the right systems in place,” said Charlee Gribbon, an infection preventionist, in the statement.

Dr. Anne Zink, Alaska’s chief medical officer, said, "While we think this is incredibly rare, and the CDC and FDA told us this is the only known case in the US to date, reporting problems is as important as reporting successes."

The Food and Drug Administration acknowledged the incident and said it was working with Pfizer and the CDC to better understand what happened.

In a late stage trial of 44,000 participants, the Pfizer vaccine was shown to be safe and about 95 percent effective.

At a press conference at Elmhurst Hospital in Queens, New York City officials on Wednesday said that no adverse reactions had been observed in the more than 1,600 hospital workers that had been vaccinated to date, but that they were closely monitoring information from around the country and the CDC.

Dr. Dave Chokshi, the city's health commissioner, said that individuals had experienced some of the common side effects that surfaced among those in the study: pain or soreness in the injection area, fatigue and muscle aches.

He described the reactions as "mild side effects."

Alaska officials described the woman who is currently hospitalized as doing well. They added that she is still encouraging others to get the vaccine.

Tagged

covid-19 updates

coronavirus

Elizabeth Kim

Elizabeth Kim is a reporter on the People and Power desk who covers mayoral power. She previously covered the pandemic, housing, redevelopment and public spaces. A native of Queens, she speaks fluent Mandarin. Got a tip? Email [email protected]

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