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FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations


23 Sep 2021

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in: individuals 65 years of age and older; individuals 18 through 64 years of age at high risk of severe COVID-19; and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19


The Most Common COVID-19 Booster Shot Questions, Answered


23 Sep 2021

The Food and Drug Administration has authorized Pfizer COVID-19 booster shots for people over the age of 65 and other at-risk Americans. The agency’s decision was the latest twist in the ongoing debate about when coronavirus booster shots would be necessary — and for whom.


Covid Live Updates: Extra Dose of J. & J. Vaccine Raises Protection, Company Says


21 Sep 2021

In a clinical trial, researchers found that two doses of the vaccine delivered 94 percent efficacy against mild to severe Covid-19.


Breakthrough Infections in Vaccinated People Less Likely to Cause ‘Long COVID’


14 Sep 2021

There’s no question that vaccines are making a tremendous difference in protecting individuals and whole communities against infection and severe illness from SARS-CoV-2, the coronavirus that causes COVID-19. And now, there’s yet another reason to get the vaccine: in the event of a breakthrough infection, people who are fully vaccinated also are substantially less likely to develop Long COVID Syndrome, which causes brain fog, muscle pain, fatigue, and a constellation of other debilitating symptoms that can last for months after recovery from an initial infection.


COVID-19 Infected Many More Americans in 2020 than Official Tallies Show


07 Sep 2021

At the end of last year, you may recall hearing news reports that the number of COVID-19 cases in the United States had topped 20 million. While that number came as truly sobering news, it also likely was an underestimate. Many cases went undetected due to limited testing early in the year and a large number of infections that produced mild or no symptoms. Now, a recent article published in Nature offers a more-comprehensive estimate that puts the true number of infections by the end of 2020 at more than 100 million [1]. That’s equal to just under a third of the U.S. population of 328 million. This revised number shows just how rapidly this novel coronavirus spread through the country last year. It also brings home just how timely the vaccines have been—and continue to be in 2021—to protect our nation’s health in this time of the pandemic.




Articles


Coverage and Estimated Effectiveness of mRNA COVID-19 Vaccines Among US Veterans


06 Oct 2021

Question What was the COVID-19 vaccination coverage and estimated mRNA COVID-19 vaccine effectiveness (VE) among US veterans in the first 3 months following vaccine rollout? Findings In this case-control study including 6 647 733 veterans, 23% of veterans received at least 1 COVID-19 vaccination during the first 3 months of vaccine rollout. VE against infection was estimated to be 95% for full vaccination; estimated VE against COVID-19-related hospitalization was 91%, and there were no COVID-19–related deaths among fully vaccinated veterans. Meaning These findings suggest that early vaccination rollout for veterans was efficient, and estimated VE was high for this diverse US population.




Protection of BNT162b2 Vaccine Booster against Covid-19 in Israel


15 Sep 2021

Background: On July 30, 2021, the administration of a third (booster) dose of the BNT162b2 messenger RNA vaccine (Pfizer-BioNTech) was approved in Israel for persons who were 60 years of age or older and who had received a second dose of vaccine at least 5 months earlier. Data are needed regarding the effect of the booster dose on the rate of confirmed coronavirus 2019 disease (Covid-19) and the rate of severe illness. Conclusions: In this study involving participants who were 60 years of age or older and had received two doses of the BNT162b2 vaccine at least 5 months earlier, we found that the rates of confirmed Covid-19 and severe illness were substantially lower among those who received a booster (third) dose of the BNT162b2 vaccine.




Surveillance for Adverse Events After COVID-19 mRNA Vaccination


03 Sep 2021

Question Are mRNA COVID-19 vaccines associated with increased risk for serious health outcomes during days 1 to 21 after vaccination? Findings In this interim analysis of surveillance data from 6.2 million persons who received 11.8 million doses of an mRNA vaccine, event rates for 23 serious health outcomes were not significantly higher for individuals 1 to 21 days after vaccination compared with similar individuals at 22 to 42 days after vaccination.




Variants of SARS-CoV-2


13 Aug 2021

When a virus develops a new mutation, it is called a variant of the original virus. As viruses spread, they constantly change through mutations to their genetic code. Most mutations in the SARS-CoV-2 genome do not affect the functioning of the virus. However, mutations in the spike protein of SARS-CoV-2, which binds to receptors on cells lining the inside of the human nose, may make the virus easier to spread or affect how well vaccines protect people. Other mutations may lead to SARS-CoV-2 being less responsive to treatments for COVID-19.




Randomized Trial of a Third Dose of mRNA-1273 Vaccine in Transplant Recipients


11 Aug 2021

In organ-transplant recipients, the standard two-dose vaccination strategy for coronavirus disease 2019 (Covid-19) has suboptimal immunogenicity.1 Both patients and health care providers have questioned whether a third-dose booster in transplant recipients would be safe and enhance immune response.2 We performed a double-blind, randomized, controlled trial of a third dose of mRNA-1273 vaccine (Moderna) as compared with placebo (the protocol is available with the full text of this letter at NEJM.org; ClinicalTrials.gov number, NCT04885907. opens in new tab).




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