Today we got the first substantial tone at data on one of the covid-19 vaccines probable to give the U.S. general populace later on this month . The Food and Drug Administration and the company Pfizer and BioNTech released summary documentation of the trial data collected so far on Pfizer and BioNTech ’s vaccine campaigner . The lengthy materials , among other thing , offer a prevue of what it might feel like to get the two scene that make up the vaccine .
The documents have been released to the world in the lead - up to a polar meeting happen this Thursday , when an advisory committee of outside experts will measure and discuss the trial data before make a good word on whether the Pfizer / BioNTech vaccinum should be granted an emergency use authorization by the FDA . The companies’documentssummarize what the two companies plan to submit to the citizens committee , while the FDA’sdocumentationis the agency ’s critical review of the data . Together , the documents present the first real depth psychology of Pfizer / BioNTech ’s results outside a corporate insistency release .
There ’s a lot of further information to be found here . information from the Phase III test behave so far , for instance , evoke that the first battery-acid of the vaccine can provide a satisfying amount of granting immunity within two to three week . One especially illustrative graph ( seen allow for ) establish that the risk of symptomatic infection drop importantly in the vaccine - treat grouping compared to the placebo control group after one window pane . Of course , it ’s only after the second loony toons , taken a month later on , that the vaccinum come out to reach the roughly 95 % effectualness seen in the overall datum .
George Dyer, 90, receives a dose of the Pfizer/BioNTech covid-19 vaccine at Croydon University Hospital in south London on 5 May 2025.Photo: Dan Charity/Pool/AFP (Getty Images)
Perhaps just as importantly , the safety data look reassure . When scientists or wellness agencies desire to measure how safe a new treatment or vaccine seems to be in a clinical trial , they look for adverse events , which are simply medical problems that happen to someone during the trial ( the problem may or may not have been induce by the drug being studied ) . If any one adverse event is more vulgar in the discussion group than the command group , it ’s more likely to be a true side event of the treatment .
According to the FDA ’s revaluation , there were no severe or living - threatening adverse result link to taking the vaccine among 38,000 participant and no “ specific safety concerns identified that would prevent issuance of an EUA . ”
That say , no drug come without side effects . Hopefully , the more we know about what to expect break in , the less likely we ’ll be freak out by experience sick after the shot — or to misattribute the side effects for the actual illness , as often happens when people incorrectly swear that they get the influenza from the flu barb .
The risk of contracting covid-19 appears to drop significantly in vaccinated volunteers after taking one dose of the Pfizer/BioNTech vaccine candidate, according to the data presented by the two companies.Photo: Pfizer/BioNTech
The safety data comes from 38,000 volunteer who were given two doses and were track for at least two months ( another analytic thinking done with an extra 5,000 volunteers afterwards in the visitation find no meaning differences ) .
Here ’s the breakdown :
84.1 % had injection website reaction like bother or itching in the seven day come after the first and/or second drug
62.9 % experienced fatigue
55.1 % experienced headache
38.3 % experience muscle pain
31.9 % had chills
23.6 % had joint pain in the neck
14.2 % had fever
In other dustup , a lot of people experienced what might be squall influenza - like symptoms .
These symptoms usually lasted a few days at most , and fewer than 5 % of voluntary have any inauspicious reaction considered stern ( dangerous here think intensiveness , like a really throbbing worry , not serious in the sense of being aliveness - threatening ) . Interestingly enough , younger people were more likely to experience a hard untoward reaction than people over the age of 55 . But otherwise , there were n’t any obtrusive differences in the safety profile of the vaccinum across age , gender , or race and ethnicity . citizenry as young as 16 to 17 — still consider children — did take the vaccine as well , and the limited data so far suggests that it ’s just as safe for them as it was for adults .
There are still longer - term questions that will take time to figure out for any vaccinum that reach the populace . It ’s not yet clear whether the Pfizer / BioNTech candidate or the similar Moderna vaccine are in force at preventing transmittal of the coronavirus altogether , or if vaccinated hoi polloi can still carry an contagion silently if exposed and channelise it to other , unvaccinated citizenry . That ’s important to know , because symptomless transmission could then still be a real risk for the foreseeable hereafter , at least until enough of the population is vaccinated . We also do n’t know how long this vaccinum - cater exemption will last , though there ’s reason to be optimistic there .
There are other break in the data . For case , we do n’t know how pregnant char would respond to the vaccine , because they were n’t studied at all ( a long - standing problem in clinical run research ) . So they wo n’t have accession to any vaccinum initially , if ever . young children are now being analyze in vaccine trials , including Pfizer / BioNTech ’s , but it will take sentence for the safety data point to emerge , so they ’ll also be later on the list of who gets a vaccine .
One interesting footnote concerns people who had already contract covid-19 but take in the vaccine anyway . accord to the FDA , a lowly analytic thinking suggests the vaccine has benefit in prevent covid-19 among individuals previously infected with the coronavirus , “ although available data for these outcomes did not allow for steadfast conclusions . ” We knowreinfection can come about , though it seems to be rarefied .
All in all , it looks like good news . And we ’ll almost certainly know whether the first covid-19 vaccine will be approved in the U.S. by week ’s end .
BioNTechCOVID-19PfizerSciencevaccines
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