
About that new vaccine…


As the ‘Rona vaccine rolls out of deep freezers and toward a hospital near you, one man has bravely risked a 0.01% chance of death by courageously giving up his vaccine shot for you and grandma.
That man is Pfizer CEO Albert Bourla – just a charitable soul who has absolutely nothing to gain from being the first to get this vaccine to market.
When asked Monday if he had taken the vaccine, Bourla said no, explaining that there are bureaucratic rules to follow after all.
A health worker in Alaska had a serious allergic reaction after getting Pfizer Inc’s coronavirus vaccine, the New York Times reported on Wednesday, citing three people familiar with reports of the person’s health.The allergic reaction occurred on Tuesday and the person was in stable condition after being hospitalized, the New York Times reported.It was not clear if the person had a history of allergic reactions, the report said.


Among those first in line for the COVID-19 vaccine in Massachusetts are correction workers and the nearly 13,000 people incarcerated in jails and prisons in the state. The news comes as COVID cases continue to spike behind bars.
Gov. Charlie Baker included both groups in the first phase of his COVID vaccination plan, which he announced last week. The first phase also includes health care workers, police, fire and emergency responders and residents of long term care facilities and those living and working in homeless shelters. Massachusetts is one of six states to specifically include prisoners in the first phase of vaccinations, according to the Prison Policy Initiative.
The Department of Correction referred questions about the vaccine process to the state’s COVID-19 Response Command Center. It says those working and living in congregate care settings, like homeless shelters and correctional facilities, are prioritized for phase one because of the high-risk, high-exposure setting. The state estimates that 22,000 vaccines will be needed for those living and working in correctional facilities, and officials expect the vaccines to be distributed between December and February. Details about how the vaccines will be given behind bars will be clearer once the state receives vaccine shipments.
The U.S. Food and Drug Administration inspects a few thousand drug manufacturing plants every year to ensure their standards are up to par. Many of those inspections are required before a pharmaceutical company can gain approval of a new drug. They serve as a check on whether drugmakers can produce quality therapies.
But that won’t be the case for Covid-19 vaccine developers that gain emergency authorization of a shot.
FDA regulations don’t require what’s known as a pre-approval inspection for products seeking emergency use, said Jerry Weir, director of the Division of Viral Products in the FDA’s vaccines office. Weir spoke last week at a meeting of FDA advisers to discuss standards for Covid-19 vaccines.
Before approval, FDA inspections ensure compliance with regulations. Once a product is being made—as vaccines already are to get them out as quickly as possible—they can uncover quality breaches and assess whether pharmaceutical companies handled them correctly or are possibly downplaying or ignoring serious issues.


The participant who triggered a global shutdown of AstraZeneca’s Phase 3 Covid-19 vaccine trials was a woman in the United Kingdom who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, the drug maker’s chief executive, Pascal Soriot, said during a private conference call with investors on Wednesday morning.
The woman’s diagnosis has not been confirmed yet, but she is improving and will likely be discharged from the hospital as early as Wednesday, Soriot said.
The board tasked with overseeing the data and safety components of the AstraZeneca clinical trials confirmed that the participant was injected with the company’s Covid-19 vaccine and not a placebo, Soriot said on the conference call, which was set up by the investment bank J.P. Morgan.
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