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US COVID-19 markers decline; vaccine manufacturers plan to expand beneficiary pool




Across the country, the 7-day averages of new COVID-19 cases and hospitalizations are down in 43 and 49 states, respectively. According to CNBC, only Nebraska, New Hampshire, North Dakota, Vermont and Wyoming have reported an increase in new cases.

The United States reported 69,230 new cases of COVID-19 yesterday and 2,542 deaths, according to the Johns Hopkins COVID-19 Tracker. In total, the United States remains the country hardest hit by the global pandemic, with 27,950,547 cases and 495,015 deaths.

News of the decline in cases comes as Pfizer and BioNTech, the makers of the first mRNA vaccine approved for use in the United States, have started a global Phase 2/3 trial targeting pregnant women and submitted new data from temperature to the Food and Drug Administration (FDA) suggesting they could allow their COVID-19 vaccine to be stored in drugstore freezers rather than ultra-cold storage facilities.

The drugmaker said tests on the vaccine show it remained stable when stored between -25 ° C to -15 ° C (-13 ° F to 5 ° F), temperatures commonly found in pharmaceutical freezers and refrigerators. Currently, under the FDA Emergency Use Clearance for the Pfizer-BioNTech vaccine, vials must be stored at -80 ° C and -60 ° C (-112F to 76F).

“Our top priority was to quickly develop a safe and effective vaccine and make it available to the world’s most vulnerable people in order to save lives. At the same time, we have continuously collected data that could allow storage at around -20 ° C. The data submitted can facilitate the handling of our vaccine in pharmacies and give vaccination centers even greater flexibility, ”a said Ugur Sahin, CEO and co-founder of BioNTech. “We will continue to leverage our expertise to develop potential new formulations that could make our vaccine even easier to transport and use.”

Yesterday, Pfizer announced that it would begin testing its two-dose vaccine in 4,000 healthy pregnant women over 18 who were vaccinated during 24 to 34 weeks gestation. Women will be followed throughout pregnancy and infants up to the age of 6 months, Pfizer said.

Today, President Joe Biden visited the Pfizer vaccine plant in Kalamazoo, Michigan. Biden met with workers who produce the vaccine and toured the facility.

Fauci calls Israeli study interesting

Today, during a White House press briefing on COVID-19, President Biden’s chief medical adviser Anthony Fauci, MD, said he believed a new Israeli study showing that a dose of Pfizer-BioNTech vaccine was 85% effective 15 to 28 days after inoculation was “interesting”.

“These numbers sound interesting, but we don’t know how durable a single dose is,” Fauci said. “We will stick to the scientifically documented efficacy of the premium vaccine followed by a boost.”

Fauci also said he believed Pfizer and Moderna would have enough data on the safety and effectiveness of their vaccines for use in adolescents this fall, but he said the data on elementary school students was unlikely to come before the first quarter of 2022.

Six million doses delayed due to weather conditions

Andy Slavitt, White House senior adviser on COVID response, said today that 6 million doses of the vaccine have been delayed this week due to inclement weather in much of the United States, including Texas, which experiences severe power outages after a winter storm.

“We are asking vaccine delivery sites to further extend their hours of operation, offer additional appointments and try to postpone vaccinations in the days and weeks to come, as supply arrives heavily. more, ”Slavitt said during today’s press briefing.

According to the Dallas Morning News, the Centers for Disease Control and Prevention (CDC) and shipping companies postponed last Friday’s shipments, which included 407,000 first doses and 333,000 second doses to Texas, in anticipation of inclement weather.

CDC: First month of vaccine safety data shows few adverse events

Finally, today in the CDC’s Weekly Morbidity and Mortality Report, the authors describe the first month of Pfizer-BioNTech and Moderna vaccine safety data in the United States collected through the Vaccine Adverse Event. Reporting System (VAERS).

Between December 13 and January 14, 13,794,904 doses of vaccine were administered and VAERS received and processed 6,994 post-vaccination adverse event reports, of which 6,354 (90.8%) were classified as non-serious and 640 (9.2%) as serious, according to the report. The most common adverse symptoms were headache (22.4%), fatigue (16.5%) and dizziness (16.5%).

One hundred and thirteen deaths have been reported, but vaccination was not considered a cause of death for anyone.

“These data provide reassuring and useful information on what health care providers and vaccinees might expect after vaccination,” the report said. “Advising vaccine recipients to expect transient local and systemic reactions could allay concerns and encourage completion of the 2-dose vaccine series.

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