COVID-19 Updates: Mask-Wearing Decreases, Rate of U.S. Vaccination Trends Down, Pfizer and BioNTech Apply for Full FDA Approval of COVID-19 mRNA Vaccine

Woman with face mask pulled down during the covid-19 pandemic

At least 158 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, May 10, 2021, including at least 3.29 million deaths. Healthcare officials in the United States have reported at least 32.7 million positive COVID-19 cases and at least 581,000 deaths. Source: Johns Hopkins University & Medicine

At least 1.3 billion individual doses of COVID-19 vaccine have been administered worldwide as of Monday evening, including at least 260 million in the United States, representing 4% of the global population and 34.8% of the population in the U.S. Source: GitHub

Mask-wearing decreases in the U.S.

The decision among fully vaccinated people to wear a mask outside one’s home “at all times” has declined by about 10% recently, from 74% of people to 63% according to a new poll by Ipsos, a multinational market research and consulting firm headquartered in Paris.

The findings come soon after the Centers for Disease Control and Prevention (CDC) announced a relaxation of mask-wearing guidance for those who have been fully vaccinated. The poll also found that the majority of all Americans (57%) are still wearing a mask whenever they leave their homes.

Other findings from the recent poll include:

  • 8% of all people report never wearing a mask.
  • 4% of all people report never social distancing.
  • 43% of all Americans are in favor of the CDC’s recent update of mask usage recommendations.
  • One in five Americans (21%) has not heard of the new CDC mask guidance.
  • Baby Boomers (49%) and Gen Xers (46%) are more likely than Gen Zers (34%) and Millennials (35%) to be in favor of the recommendation update.

The findings were collected between April 30 and May 3, 2021 among a sample of 1,022 adults aged 18 and older from the continental U.S., Alaska, and Hawaii. The poll has a margin of error of plus or minus 3.3 percentage points for all respondents, according to Ipsos officials.

Rate of U.S. vaccination trends down, but optimism remains

For the first time since early March, the seven-day average of COVID-19 vaccine administration in the United States fell below 2 million per day, according to recently published data by the Centers for Disease Control and Prevention (CDC).

Still, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, also recently estimated that about 70-85% of people would need to be immune for the country to reach what he described as a “total blanket of protection,” in an article published by CNN.

However, Fauci also noted that a more liberal approach to the use of masks indoors could also be warranted as more people overall become vaccinated.
Dr. Jonathan Reiner, professor of medicine and surgery at George Washington University, also told CNN that when the country reaches a 60% mark of adults who have received at least one dose of vaccine that the number of total cases of the virus and deaths in the country should dramatically drop — which could happen some time in May, he predicts.

As U.S. President Joe Biden sets a new goal of administering at least one vaccine dose to at least 70% of American adults by July 4, White House COVID-19 response coordinator Jeffrey Zients claims in the same CNN report that “we are turning the corner.”

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Pfizer, BioNTech apply for FDA Biologics License Application

Officials at Pfizer Inc. and BioNTech have announced the initiation of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for full approval of the COVID-19 mRNA vaccine in individuals 16 years of age and older. Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review, according to a news release distributed by the companies on May 7. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA will be set once the BLA is complete and formally accepted for review by the agency.

The vaccine is currently available in the U.S. under an Emergency Use Authorization (EUA). Submission of a BLA requires longer-term follow-up data for acceptance and approval.

“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. government,” said Albert Bourla, chairman and chief executive officer at Pfizer. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”

Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 and older. This includes the most recent analyses from the Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose.

The current EUA for the Pfizer/BioNTech vaccine has also recently been expanded to include individuals 12-15 years of age. The companies intend to submit a supplemental BLA to support licensure of the vaccine in this age group once the required data six months after the second vaccine dose are available, officials said.

“Following the successful delivery of more than 170 million doses to the U.S. population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, MD, chief executive officer and co-founder of BioNTech. “We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”

Does alcohol weaken the vaccine?

The polarizing nature that has become connected to receiving a COVID-19 vaccine may incline some people to actually celebrate receiving the shot. But can celebrating with alcoholic beverages reduce the effectiveness of the vaccines?

While there’s not yet literature specifically about whether drinking interferes with the coronavirus vaccines, excessive drinking can impair the immune system, according to a 2015 study.

Still, according to a recent report by The New York Times, moderate drinking is not perceived to be a risk, say experts from the Center for Virus Research at the University of California at Irvine and the Mayo Clinic.

The Centers for Disease Control and Prevention (CDC) defines moderate alcohol consumption as up to one drink for women and up to two drinks for men daily.

Stay up-to-date on the latest coronavirus news developments. Visit our Resource Center each week for new COVID-19 updates—plus a variety of other resources for healthcare professionals.

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