24-Hour Crisis Hotline: (877)SAFEGBC or (877)723-3422 Mental Health & Substance Abuse Issues

6502 Nursery Drive, Suite 100
Victoria, TX 77904
(361)575-0611
Fax: (361)578-5500
Regular Hours: M-Fri 8am - 5pm
Every 3rd Thurs of the Month - Extended Hours Until 7 pm

Medical Disorders
Resources
Basic InformationLookupsLatest News
Scientists Find Clues to Why AstraZeneca's Vaccine May Cause ClotsYou've Got Fungi in Your Lungs, and That's OKNon-Emergency Surgeries Are Rebounding, But Backlogs RemainPandemic Has Put Many Clinical Trials on HoldSupply of J&J COVID Vaccine to Drop 86 Percent Next WeekStressed, Exhausted: Frontline Workers Faced Big Mental Strain in PandemicNIH Starts Trial Looking at Rare Allergic Reactions to COVID VaccinesNot Just Keyboards: Many Types of Workers Can Develop Carpal TunnelBlack Women Are Dying of COVID at Much Higher Rates Than White MenTwo Vaccines Show Effectiveness Against Emerging COVID VariantsWomen More Prone to Concussion's Long-Term Harms: StudyCOVID Cases Climb in the Midwest as British Variant Takes Hold in U.S.'Heart-in-a-Box' Can Be Lifesaving, Matching Up Distant Donors With PatientsNo Proof COVID Vaccines Can Trigger Guillain-Barré SyndromeFor People With PAD, Exercise Can Be Tough But RewardingPublic Lost Trust in CDC During COVID Crisis: Poll1 in 3 COVID Survivors Struggle With Mental Health Issues Months LaterA Few People With COVID Went a Crowded Bar: Here's What HappenedNearly 8 in 10 School, Child Care Staff Have Gotten at Least 1 Dose of COVID Vaccine: CDCModerna COVID Vaccine Offers Protection for at Least 6 Months: StudyStrain of COVID Care Has Many Health Professionals Looking for an ExitCOVID Shot Earlier in Pregnancy Better for Baby: StudyDoctors' Group Says Antibiotics Can Be Taken for Shorter PeriodsIf You've Had COVID, One Vaccine Jab Will Do: StudyAbout 40,000 U.S. Children Have Lost a Parent to COVID-19Study Refutes Theory That Blood Type Affects COVID RiskHow Willing Are Americans to Donate COVID Vaccines to Other Countries?Got Your COVID Vaccine? Don't Stop Being Cautious, Experts SayCOVID Drove 23% Spike in U.S. Deaths In 2020Faster-Spreading COVID Variant Expanding in United StatesWhen Will America's Kids Get Their COVID Vaccines?AHA News: Why You Should Pay Attention to InflammationMany Recovering COVID Patients Show Signs of Long-Term Organ DamageCOVID Fears Mean More Cancers Are Being Diagnosed at Later StagesSome Hospitalized COVID Patients Develop SeizuresCan Vaccinations Stop COVID Transmission? College Study Aims to Find OutCDC Confirms COVID as Third Leading Cause of Death in 2020Research Reveals How Aspirin Helps Prevent Colon CancerPfizer Says Its COVID Vaccine Is Very Effective in Kids as Young as 12AHA News: The Secret to Good Health Is No Secret. So Why Is It So Hard to Achieve?'Couch Potato' Lifestyles Cause Up to 8% of Global Deaths: StudyHave to Travel During Spring Break? Here's How to Stay SafeNew Coronavirus Can Also Infect Cells in the MouthBiden, Top Health Officials Warn of Risk of Another COVID SurgeAHA News: Black Young Adults Face Higher Stroke Risk Than Their White PeersReal-World Proof That Pfizer, Moderna Vaccines Slash COVID InfectionsStudy Ties Gum Disease to High Blood PressureSmoking Rates High Among Surgery PatientsBiden Administration Working on 'Vaccine Passport' InitiativeSpring Activity Can Sometimes Bring Stress Fractures
Questions and AnswersLinks
Related Topics

Diabetes

New Variants Mean COVID Vaccines, Tests May Need Tweaking: FDA

HealthDay News
by By Dennis Thompson HealthDay Reporter
Updated: Feb 22nd 2021

new article illustration

MONDAY, Feb. 22, 2021 (HealthDay News) -- The emergence of new SARS-CoV-2 variants could require a quick pivot on the part of pharmaceutical and medical device companies, to help stay one step ahead of COVID-19.

The U.S. Food and Drug Administration issued guidelines Monday encouraging drug and test developers to pay attention to new coronavirus variants and be prepared to make that pivot if necessary.

The guidance provides recommendations for companies seeking to tweak already-approved vaccines, medicines and tests so that they will remain effective against any new variants that emerge.

"Many of these products might be impacted by changes to the virus, particularly their efficacy or their performance," acting FDA Commissioner Dr. Janet Woodcock said during a media briefing Monday.

"We recognize we are in a pandemic situation and we need to make sure that health care providers have the best available diagnostics, therapeutics and vaccines to fight the virus. These may need to be modified over time to remain maximally effective," Woodcock added.

The emergence of highly infectious new SARS-CoV-2 variants out of the United Kingdom, South Africa and Brazil have raised concerns that mutations might weaken the effectiveness of vaccines and drugs now used to treat the disease.

Studies have shown that the two vaccines now on the market remain effective in thwarting the U.K. and South African variants of the virus that causes COVID-19, but experts are worried that monoclonal antibody treatments might not work as well.

"Monoclonal antibodies are laboratory-made proteins that mimic the immune system in fighting off harmful pathogens such as viruses," Woodcock said. "We know that some of the monoclonal antibodies that are currently authorized are less active against some of the SARS-CoV-2 variants that have emerged and are prevalent in some parts of the world."

There are similar concerns about the effectiveness of COVID-19 tests to detect the new variants. The FDA has already issued a safety alert to caution that the presence of viral genetic mutations in a patient sample can potentially change the performance of a diagnostic test.

"The FDA has identified a few tests that are known to be impacted by emerging viral mutations, although at this time the impact does not appear to be significant," Woodcock said.

The agency also issued guidance to help pharmaceutical companies prepare for tweaks to vaccines if a new variant emerges that flouts the antibody protection provided by the Pfizer and Moderna vaccines.

Companies should be prepared to test either reworked vaccines or new booster shots that would protect against emerging variants, after smaller-scale clinical trials that would involve a few hundred people and last two or three months, Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said during Monday's briefing.

"We think it's prudent to start doing clinical trials," Marks said, later adding, "We are encouraging people to start them sooner rather than later, without necessarily triggering production yet."

More information

The U.S. Centers for Disease Control and Prevention has more on coronavirus variants.


SOURCES: Feb. 22, 2021, media briefing with: U.S. Food and Drug Administration Commissioner Janet Woodcock, MD; Peter Marks, MD, PhD, director, FDA's Center for Biologics Evaluation and Research