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6 things about 2nd COVID-19 vaccine + Is Bell's palsy a side-effect of mRNA vaccine?

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Bell's palsy and COVID-19 mRNA vaccines – let's temper the concerns
https://www.skepticalraptor.com/skeptica...-concerns/

EXCERPT: . . . Let’s get right to the point – the FDA does not consider Bell’s palsy to be a side effect of either the Moderna or Pfizer vaccines. However, because each vaccine’s phase 3 clinical trials showed a tiny number of incidents of the condition, the FDA, because it’s a cautious agency, has decided to monitor the situation.

During the Moderna clinical trial, four out of approximately 30,000 people developed Bell’s palsy, three of those had received the vaccine. Similarly, four out of the 43,000 people in the Pfizer clinical trial contracted Bell’s palsy, all of whom received the vaccine. The condition was noted between 22 and 32 days after receiving the vaccines. Two of the cases in the Moderna trial have already resolved.

As a comparison, the incidence of Bell’s palsy is about 23 – 35 per 100,000 people per year, which is around 5X higher than what was observed in both arms of the Moderna and Pfizer clinical trials. In other words, the risk of Bell’s palsy is substantially lower in the vaccinated groups than in the general population... (MORE - details)


6 Things To Know About The Second COVID-19 Vaccine The FDA Is Expected To Authorize Soon
https://www.buzzfeednews.com/article/ste...us-vaccine

EXCERPTS: Moderna’s vaccine appears to have some key advantages over Pfizer’s, making it a possibly even more powerful tool. It can be much more easily transported and stored, and data suggests that it could be effective even after the first dose.

"The evidence that has been studied in great detail on this vaccine highly outweighs any of the issues that we’ve seen," Hayley Gans, a pediatrician at Stanford University, said at the panel meeting on Thursday. "It really supports us being able to, with the pandemic in our background, really move forward and finally provide a safe and effective way to get to herd immunity."

About 2.9 million doses of Pfizer’s vaccine were shipped out across the country this week, and another 2 million are slated to be delivered next week. If Moderna’s vaccine gets authorized for emergency use by the FDA, another nearly 6 million doses would go out next week, according to federal officials with Operation Warp Speed, the federal government’s private–public investment effort to develop coronavirus therapeutics and vaccines.

[...] An open question has been whether the vaccines tested so far can also prevent people from getting infected and passing the infection on to others, versus just getting sick enough to have symptoms. Importantly, the new data shows that Moderna’s vaccine might also help prevent asymptomatic infections — that is, cases in which people test positive without having symptoms — which are believed to make up as much as 20% to 30% of all COVID-19 cases, and to be a significant driver of transmission because people spread the virus to others without realizing they’re sick.

[...] The safety data, too, was encouraging, with FDA staff reporting “no specific safety concerns” about the vaccine. [...] Side effects were common and typical of the mild to moderate reactions associated with vaccines in general: soreness, fatigue, headaches, muscle pain, joint pain, and chills. There wasn’t enough data to draw conclusions about how safe the vaccine was for people who were pregnant or had immunocompromised systems.

Moderna’s vaccine appears to cause these side effects more often than some other standard vaccines, but the reactions still seem to be relatively moderate and temporary, according to Benkeser. [...] Other questions have been raised about whether it is safe for people with severe allergies to get vaccinated with Pfizer’s vaccine, and if those concerns might apply to Moderna’s vaccine. This week, there were reports of two people at an Alaska hospital who experienced allergic reactions after getting Pfizer’s immunization. On Thursday, FDA staff said the agency did not have enough information about the cases, but was investigating alongside the CDC.

FDA officials also said that in Moderna’s clinical trial, there were reports on rashes, hives, and itching, but “nothing that really are close even to anaphylaxis,” or a severe, potentially life-threatening allergic reaction.

[...] In terms of how it works, Moderna’s vaccine looks like it has two clear advantages over Pfizer’s: It may be more effective after just one dose, and it’s better at preventing severe cases.

Getting the full Moderna vaccine requires taking both shots 28 days apart, versus 21 days for Pfizer’s, and there will almost certainly be some number of people who forget to return to the doctor’s office for their second shot. Moderna presented relatively stronger evidence that just one dose could offer protection from COVID-19, as much as 80% in the month before the second dose. In comparison, the first shot of Pfizer’s vaccine was only about 52.4% effective at lowering the rate of COVID-19 diagnoses when compared to placebo.

Data also indicated that Moderna’s vaccine could prevent illnesses that required oxygen or hospitalization — the kinds of cases that are overwhelming intensive care units around the country. While 30 people in the placebo group got seriously ill starting two weeks after their second dose, none of the vaccinated people did. Pfizer’s trial, in contrast, produced less evidence showing it could stave off these severe cases.

“It’s not to say that Moderna’s vaccine is necessarily better at preventing severe disease than Pfizer’s, just that we’re more confident in the results that we’ve seen from Moderna at this point,” Benkeser said.

[...] Moderna’s vaccine also has some advantages in terms of how easily it can be delivered to people. The Moderna vaccine should be much easier to administer to people outside of massive medical facilities and large cities. It is shipped at freezer temperatures of -4 degrees Fahrenheit, making it a lot easier to manage than the Pfizer one, which requires dry ice shipping and storage at the ultracold temperature of -94 degrees. Moderna’s vials can be stored at refrigerator temperatures for up to 30 days, and at room temperatures for half a day.

It also comes in smaller 100-dose packages, unlike Pfizer’s dry ice boxes, which contain 975 doses that need to be used quickly for large numbers of volunteers to prevent spoilage. Pfizer’s large packages have made the vaccine inaccessible in less populated rural areas that can’t use up the full supply of doses... (MORE - details)

RELATED: https://www.scivillage.com/thread-9519-p...l#pid40537
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