Healthcare Roundup – Two healthcare workers suffer allergic reactions to Pfizer/BioNTech COVID-19 shot, United Airlines partners with XpresSpa for COVID-19 testing

Published on: December 17, 2020
Author: Amy Liu

Two healthcare workers suffer allergic reactions to Pfizer/BioNTech COVID-19 shot – NYT

Two healthcare workers in Alaska has had a severe allergic reaction to Pfizer (NYSE:PFE) and BioNTech’s (NASDAQ:BNTX) COVID-19 vaccine, the New York Times reported, but experts say that the vaccine is still safe for the general public.

The first worker, a middle-aged woman, with no history of allergies experienced anaphylactic reaction just 10 minutes after receiving a shot at Bartlett Regional Hospital in Juneau.

She experienced a rash over her face and torso, shortness of breath and an elevated heart rate. The symptoms resolved after being administered with allergy treatment epinephrine and steroids. The patient was still in hospital being monitored on Wednesday.

The second worker received his shot on Wednesday and developed eye puffiness, lightheadedness and a scratchy throat 10 minutes after the injection, the hospital said in a statement.

He was treated with epinephrine, Pepcid and Benadryl and the worker was back to normal within an hour and released.

The episode follows reports of a handful of similar reactions in the U.K., where health officials advised that anyone with a history of severe allergies shouldn’t take the Pfizer vaccine.

Pfizer is coordinating with local officials, will closely monitor all reports suggesting serious allergic reactions and will update labeling language if needed, spokeswoman Jerica Pitts said in a statement.

Storage of Pfizer-BioNTech vaccine is also challenging as it must be kept at ultracold temperatures in specialized freezers and containers.

Four delivery trays of the shot were pulled back from delivery to California and Alabama this week and sent back to the company because they were colder than anticipated, according to Gustave Perna, chief operations officer of Operation Warp Speed.

Each of the trays can likely be used to vaccinate 975 people. Pfizer’s formula needs to be stored at -70 degrees Celsius, equivalent to -94 degrees Fahrenheit.

U.S. officials also said that Pfizer would deliver about 900,000 fewer doses next week than the 2.9M available this week when the first shots shipped.

Administration of the vaccine began Monday in the U.S., following emergency-use authorization last week.

United Airlines partners with XpresSpa for COVID-19 testing

XpresSpa (NASDAQ:XSPA) soars 30% in pre-market, on announcing its XpresCheck subsidiary had entered into a national agreement with United Airlines to offer COVID-19 testing services starting with Newark Liberty International Airport and Denver International Airport.

XpresCheck will support direct flights to Hawaii creating air bridges between more airports and vacation destinations, beginning Monday, December 21, 2020.

XpresCheck to provide pre-travel testing on-site with rapid molecular testing services to individuals, in order to detect the active presence of the COVID-19 virus and reduce the risk of spreading the virus.

XpresSpa opened the XpresCheck COVID-19 testing facility at Denver International Airport yesterday.

J&J says late-stage COVID vaccine trial fully enrolled

Johnson & Johnson (NYSE:JNJ) says it has fully enrolled participants for the first late-stage trial of its COVID-19 single-dose vaccine candidate.

The Ensemble trial has enrolled ~45K participants and is being conducted by its Janssen unit, J&J says, adding that it expects interim data from the trial by the end of January.

The company plans to submit an emergency use authorization application to the U.S. Food and Drug Administration in February if the study shows the vaccine is safe and effective.

The Ensemble trial was paused in October after a patient developed an “unexplained illness” during the study, but J&J resumed the trial after an evaluation found no clear cause for the illness.

J&J “should have vaccine and dividend tailwinds in 2021,” Zvi Bar writes in a bullish analysis posted recently on Seeking Alpha.

Moderna wins Adcom backing for COVID-19 vaccine

Vaccines and Related Biological Products Advisory Committee of the FDA has endorsed the COVID-19 vaccine candidate from Moderna (NASDAQ:MRNA), STAT News reports.

The question of ‘based on the totality of scientific evidence available, do the benefits of the Moderna Covid-19 vaccine outweigh its risks for use in individuals 18 years of age and older?’ has received 20 votes in favor with one abstention.

Though FDA is not bound by the endorsement, the regulator often follows the recommendation, which could potentially lead Moderna to win EUA as early as this week.

Last week, Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) became the first vaccine candidate to win the EUA after the expert panel voted 17-4 with one abstention.

After a +5.1% rise during the day, the shares have added +1.4% in afterhours trading

GSK, Vir Biotech initiates of NIH-sponsored VIR-7831 study in COVID-19

Vir Biotechnology (NASDAQ:VIR) and GlaxoSmithKline (NYSE:GSK) have announced dosing of the first patient in a new sub-trial of the National Institutes of Health’s (NIH) ACTIV Program Phase 3 trial, evaluating VIR-7831 (a.k.a GSK4182136) for the treatment of hospitalized adults with COVID-19.

The study will assess safety and efficacy of the monoclonal antibody.

ACTIV-3 is one of several ongoing trials in the NIH’s ACTIV program, a public-private partnership designed to accelerate development of COVID-19 treatments and vaccine candidates.

In addition to the Phase 3 ACTIV-3 trial, VIR-7831 is also being evaluated in the global Phase 2/3 COMET-ICE trial for the early treatment of COVID-19 in adults at high risk of hospitalization.

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