More than 402 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Wednesday morning, February 9, 2022, including more than 5.7 million deaths. Healthcare officials in the United States have reported more than 78.5 million positive COVID-19 cases and more than 932,000 deaths. Source: www.worldometers.info/coronavirus
More than 10.2 billion individual doses of COVID-19 vaccine have been administered worldwide as of Wednesday morning, including at least 544 million in the United States. Source: GitHub
Pfizer and BioNTech move forward with vaccine for youngest children
A rolling submission to amend an Emergency Use Authorization (EUA) for vaccinating children ages 6 months to 4 years has been submitted to the U.S. Food and Drug Administration (FDA) by officials at Pfizer Inc. and BioNTech.
Company officials say the request comes in response to the urgent public health need in this patient population. The application is for authorization of the first two 3-µg doses of a planned three-dose primary series. Data on a third dose given at least eight weeks after completion of the second dose are expected in the coming months and will be submitted to the FDA to support a potential expansion of this requested EUA, according to a press release dated Feb. 1.
Since the pandemic began, more than 10.6 million children have tested positive for COVID-19 in the U.S., with children younger than 4 years accounting for more than 1.6 million of those cases, according to the American Academy of Pediatrics and the U.S. Centers for Disease Control and Prevention (CDC).
Further, reported COVID-19 cases and related hospitalization among children have spiked dramatically across the United States during the Omicron variant surge. For the week ending Jan. 22, children younger than 4 accounted for 3.2% of the total hospitalizations due to COVID-19, according to the CDC.
If authorization is granted, the vaccine would be the first vaccine available to help protect children younger than 5 years of age, potentially including future emerging variants of concern.
“As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” said Albert Bourla, chairman and chief executive officer at Pfizer. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose.”
The request to amend the EUA is based on the totality of data on the safety, tolerability, immunogenicity, and available efficacy of two doses of the vaccine. The companies also plan to share data with the European Medicines Agency and other global regulatory agencies.
“Our vaccine has already demonstrated a favorable safety, tolerability and efficacy profile in multiple clinical trials and real-world studies for all age groups starting from 5 years old,” said Ugur Sahin, MD, chief executive officer and co-founder of BioNTech. “If authorized, we are very excited about the prospect of offering parents the opportunity to help protect their children 6 months through 4 years of age from COVID-19 and the potentially severe consequences of infection.”
WHO attributes additional medical waste to pandemic
Increased demand for gloves and other personal protective equipment (PPE) during the COVID-19 pandemic has resulted in a massive amount of global healthcare waste, according to officials with the World Health Organization (WHO).
Billions of items, including masks and vaccination syringes have reportedly accounted for tens of thousands of tons of medical waste that has strained waste management systems and is threatening overall healthcare and the environment.
There’s now a “dire need” to improve those systems and get a response from both governments and people, according to a recent report by the Associated Press.
The report states that WHO officials have found that most of the approximately 87,000 tons of such equipment obtained from March 2020 to November 2021 has become waste. Additionally, more than 8 billion doses of vaccine administered globally have produced 143 tons of extra waste in terms of syringes, needles, and safety boxes.
The WHO issued recommendations such as the use of “eco-friendly” packaging and shipping as well as reusable equipment and recyclable or biodegradable materials as a potential resolution. The WHO is also calling for an investment in “non-burn waste treatment” technologies.
Earlier boosters coming for some patient populations
Certain patients with weakened immune systems will be encouraged to receive a COVID-19 booster dose three months after completing their initial series of the Pfizer-BioNTech or Moderna vaccine as opposed to the current interval of five months, according to a recent report by the Washington Post that cites guidance by the U.S. Centers for Disease Control and Prevention (CDC).
CDC officials reportedly presented the anticipated changes Feb. 4 during a meeting with external vaccine experts who sit on the Advisory Committee on Immunization Practices. The updated guidance is expected to include recommendations for some immunocompromised people who are at increased risk for severe complications and are more likely to become infected after vaccination.
Additional guidance revisions could also be coming for patients who have received the one-shot Johnson & Johnson vaccine to receive an additional booster dose at least two months after an initial booster.
The report also claims that the CDC will be adding language to allow physicians to use clinical judgment in giving patients mRNA vaccines outside the dosing intervals approved by federal regulators.
The panel members reportedly welcomed the anticipated changes.
N95 and KN95 masks provide more significant protection, CDC finds
While any mask worn indoors is associated with better protection from the coronavirus, the U.S. Centers for Disease Control and Prevention (CDC) has determined that high-quality N95 and KN95 masks offer the best chance of avoiding infection.
According to the CDC’s most recent weekly Morbidity and Mortality Weekly Report, surgical masks reduce the chances of testing positive through exposure in indoor public settings by 66%. Professional N95 and KN95 masks with tightfitting face coverings reduce infection odds by 83%. Wearing a cloth mask was associated with reducing the chances of testing positive by 56%.
Research for the report was reportedly conducted by the California Department of Public Health from Feb. 18-Dec. 1, 2021 and included 652 people who had recently tested positive for the virus matched with 1,176 who had tested negative.
Participants were asked about public indoor settings they had visited within 14 days before being tested and whether they had worn a mask. Participants were also matched by vaccination status and other characteristics, according to the CDC.