COVID-19 vaccines Archives - Page 11 of 24

U.S. could announce COVID-19 vaccine booster plan in early September

Pfizer-BioNTech COVID-19 vaccine. [Image courtesy of Wikimedia Commons]

In response to the largest coronavirus spike in infections in months, the FDA is prepping a plan for COVID-19 vaccine boosters.

The plan will likely follow other guidelines by prioritizing boosters for immunocompromised and elderly individuals, according to a report from WSJ.

The U.K., Germany and Israel have recommended providing boosters to high-risk populations.

The growing support of COVID-19 boosters in several countries comes as the WHO has called to suspend the use of boosters until late September to make more vaccine doses available to the developing world.

The White House has disputed the WHO recommendation as a false dichotomy, explaining the U.S. could continue donating more COVID-19 vaccines doses while providing booster doses to vulnerable populations, according to White House press secretary Jen Psaki. W…

U.S. government withholds funding from Novavax

Although Novavax (NSDQ:NVAX) disclosed the news in a July 31 SEC filing, investors apparently didn’t react to the development until today. In mid-day trading, the stock dipped 20% to $188.18. The company’s stock had surged earlier in the week.

In the SEC filing, Novavax said the U.S. government told the company to align its analytic methods with the FDA before planning additional domestic manufacturing. Furthermore, the government told Novavax that it would withhold funding for additional manufacturing until the company had done so.

The company had landed a $1.75 billion contract as part of the U.S. government’s Operation Warp Speed program to produce a COVID-19 vaccine. The U.S. agreed to purchase 110 million doses of the vaccine after it receives emergency use authorization.

Similar to Moderna, the COVID-19 vaccine will be Novax’s first commercial product.

The New York Times report suggests that Novavax has struggled to convince the FDA th…

How Delta could change the COVID-19 landscape

[Image courtesy of CDC]

Delta is “an extremely transmissible variant and has taken us all for a loop,” said Dr. Monica Gandhi, a professor of medicine and associate division chief of the division of HIV, infectious diseases and global medicine at University of California, San Francisco.

But despite Delta’s hurricane-like ascent, the volume of infections it drives are likely to fall just as quickly after peaking, Gandhi said in a webinar from the Bay Area Council.

Delta could peak anywhere from mid-August to mid-October, according to several experts quoted in WebMD.

In the interim, Delta will remain most threatening for the unvaccinated and those without prior COVID-19 infections, although the variant will likely continue to drive breakthrough infections in vaccinated individuals.

In highly vaccinated areas of the U.S. where the vaccine has spread, there has been a “decou…

Novavax stock surges after striking EU COVID-19 vaccine deal

Novavax (NSDQ:NVAX) saw its stock jump more than 20% in afternoon trading after the European Commission agreed to purchase up to 200 million doses of its vaccine.

The Gaithersburg, Md.–based vaccine maker announced in March that its NVX-CoV2373 vaccine was 96.4% effective against the original SARS-CoV-2 strain in a U.K. trial. The efficacy in a later trial conducted in the U.S. and Mexico was 90.4%, according to a June NIH press release.

But the company had been slow to get its vaccine onto the market. In the U.S., the company plans on filing for emergency use authorization in late September.

Get the full story from our sister site, Drug Discovery & Development.

WHO aims to halt COVID-19 vaccine boosters to spur vaccination in developing world

The World Health Organization (WHO) has called to put plans to distribute booster shots on hold until late September to enable more equitable vaccine access across the world.

At present, only 14% of the world’s population is fully vaccinated, and, in some countries, only a sliver of people have obtained vaccines. However, vaccination rates are flagging in much of the developing world. In Bangladesh, for instance, only 2.7% of people are fully vaccinated, according to Our World in Data. In Niger, 0.7% of the public has reached that milestone.

In a media briefing, the world is understandably concerned about the Delta variant, said Tedros Adhanom Ghebreyesus, director-general of the WHO. “But we cannot accept countries that have already used most of the global supply of vaccines using even more of it, while the world’s most vulnerable people remain unprotected,” he explained.

WHO wants all countries to vaccinate at least 10% of their populations by the end …

COVID-19 vaccination rates ticking up as Delta fuels infections

Image courtesy of Pexels

The rate of vaccination in the U.S. continues to tick upward. On Aug. 1, healthcare workers administered 816,203 doses, marking one of the highest totals in recent weeks.

Vaccination rates have increased about 24% in the past week, according to an estimate from UBS.

If the trend holds, the daily vaccination rate could surpass one million — roughly in line with the pace in late June.

At present, almost 58% of all Americans have received at least one COVID-19 vaccine dose.

In early July, the daily rate of U.S. vaccinations hit its lowest point since the beginning of the year. At that time, health officials administered about 500,000 doses daily.

As a result of the lagging vaccination rate, the U.S. was about a month late in meeting President Biden’s goal to provide at least one vaccine dose to 70% of adults by July 4. Some 60.6% of U.S. adults are fully vacc…

Biden offers $100 incentives to spur COVID-19 vaccination

Image courtesy of Pexels

With COVID-19 transmission continuing to accelerate, President Biden called for state and local governments to offer financial incentives for vaccination.

Speaking at a White House briefing dedicated to the novel coronavirus, Biden offered to draw such funding from the $1.9 trillion American Rescue Plan.

“People are dying and will die who don’t have to die,” he said in the announcement. “If you’re out there unvaccinated, you don’t have to die.”

Biden also said the government would reimburse small- and medium-size businesses that support vaccinating their employees.

He has also called for federal employees to be fully vaccinated or face regular testing and masking restrictions indoors.

Biden acknowledged that the plan might seem unfair for people who are already fully vaccinated but said the initiative could help beat back the spread of the virus.

Ju…

FDA signs of on extended shelf life for J&J vaccine

FDA has agreed to extend the shelf life of the Johnson & Johnson COVID-19 to six months. The previous shelf life was four and a half months.

The regulatory agency based its decision on data from ongoing studies involving vaccine doses stored at the previously indicated storage temperature of 2–8°C (35.6–46.4°F).

There is currently a stockpile of J&J viral-vector vaccine across the U.S. Vaccination rates in the U.S. have slumped in recent months. The rare possibility of blood clots stemming from the vaccine has contributed to diminished demand. And the mRNA vaccines from Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) continue to be the most popular options. More than 150 million Americans have received two doses of the mRNA vaccines from Pfizer and Moderna, while some 13 million have received the single-dose J&J vaccine.

Pfizer highlights COVID-19 and flu vaccine strategy in Q2 earnings call

With vaccines generating a significant portion of Pfizer’s (NYSE:PFE) revenue in the first six months of 2021, the company shed light on its vaccine plans in its most recent quarterly earnings call.

While the company recently won FDA approval for its potential blockbuster pneumococcal 20-valent vaccine, its mRNA vaccine strategy understandably took center stage during the Q2 call yesterday.

Pfizer working on an mRNA flu vaccine

Pfizer began working with BioNTech (NSDQ:BNTX) to develop an mRNA-based flu vaccine in 2018. The mRNA platform could boost flu vaccine efficacy and lead to a better immune response. Traditional flu vaccines are between 40% and 60% effective among the overall population, according to the CDC.

The company aims to launch human trials for a modified RNA flu vaccine in the third quarter of the year.

Delta variant concerns

Pfizer is currently running a clinical trial to test the use of a third dose of its vaccine six to 12 months…

Pfizer shares surge on strong Q2

Pfizer (NYSE: PFE) posted second-quarter results today that beat the consensus forecast. In addition, thanks to solid vaccine sales, the company boosted its outlook for the remainder of the year. The company expects annual sales of the two-dose vaccine it jointly developed with BioNTech to hit $3.5 billion.

The New York City–based company reported profits of $5.563 billion, or $0.98 per share, on sales of $19.0 billion for the three months ended June 30, for a bottom-line gain of 59% and operational growth of 86% compared with Q2 2020.

Adjusted diluted earnings per share were $1.07, eight cents ahead of The Street, where analysts were looking for EPS of $0.99 on sales of $9.9 million.

“I couldn’t be prouder of the way Pfizer has started 2021,” said Pfizer CEO Dr. Albert Bourla in the earnings call.

While COVID-19 vaccine sales drove the majority of its growth in the second quarter, Bourla said the company is “equally proud of the second-quarter pe…

Preprint shows strong but fading efficacy of Pfizer vaccine at six months

An ongoing study involving the BNT162b2 COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) could potentially underscore the need for boosters. But more data are needed to understand vaccine performance over time, according to a preprint published on MedRxiv.

Pfizer CEO Dr. Albert Bourla has previously predicted that booster doses of the vaccine would be needed. Still, the U.S. government has yet to embrace that view for the general population. A CDC advisory committee, however, recently endorsed the use of boosters in immunocompromised patients.

The study found that the efficacy of the BNT162b2 vaccine peaked between seven days to less than two months after the administration of the second dose. Four-to-six months after the second dose administration, the efficacy waned to 83.7%. Efficacy declined an average of roughly 6% every two months, according to the paper. “Ongoing follow-up is needed to understand persistence of the vaccine effect over tim…

COVID-19 vaccine mandates pick up steam

Photo by Frank Meriño from Pexels

The Department of Justice recently decided that federal law doesn’t block public or private organizations from requiring COVID-19 vaccines.

Following that decision, a growing number of organizations are beginning to mandate COVID-19 vaccines. The Department of Veteran Affairs became the first federal agency to do so. That decision will require full vaccination for some 115,000 workers. The Department is allowing employees eight weeks to comply. The government agency reported in a press release that four of its employees had died from COVID-19. All of them were unvaccinated.

New York City has issued a similar mandate for its 340,000 municipal workers. The order doesn’t go into effect until Labor Day, which is Sept. 6.

California will also require that state employees either receive a COVID-19 vaccine or face weekly tests and in-door mask requirements. California…