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Side effects relatively rare for Pfizer-BioNTech vaccine: Study

A recent study found that only 13.5% of recipients of the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) had systemic side effects after the first dose. That figure climbed to 22.0% after the second dose.

Conversely, just over one-third (33.7%) of recipients of the first dose of vaccine from AstraZeneca (LON:AZN) had systemic side effects, according to the study published in The Lancet.

Among those with a prior COVID-19 infection, however, systemic side effects were 2.9 times more common in recipients of the first Pfizer vaccine than those who were infection naive. For recipients of the first dose of the AstraZeneca vaccine, such side effects were 1.6 times more common in those previously infected with COVID-19.

The study, which involved 627,383 participants, ran from Dec. 8 to March 10.

Local side effects (frequently injection-site pain and tenderness) were more common than systemic events, occurring in 71.9% of recipients of th…

Pfizer and BioNTech seek EMA nod for younger adolescents

Image courtesy of Wikipedia

After announcing that its vaccine was 100% efficacious in a Phase 3 trial involving adolescents aged 12 to 15, Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) are seeking E.U. authorization to distribute the vaccine to that age group.

BioNTech’s CEO, Uğur Şahin, estimated that the vaccine would be available to early adolescents in 27 European countries starting in June.

The companies requested in early April that FDA lower the vaccine eligibility from 16 to 12 years of age.

Janet Woodcock, FDA’s acting commissioner, vowed to review the request “as expeditiously as possible using our thorough and science-based approach” but declined to estimate how long it would take to do so.

BioNTech and its partner Pfizer are currently overseeing vaccine clinical trials for children as young as six months old.

The companies also plan on asking other international regu…

Moderna pledges to manufacture up to 3B COVID-19 vaccine doses in 2022

Moderna (NSDQ:MRNA) announced today that it committed funds to increase its COVID-19 vaccine manufacturing capacity to up to 3 billion doses for 2022.

Cambridge, Mass.-based Moderna’s new funding commitments are slated to increase supply at its owned and partnered manufacturing facilities up to that 3 billion-dose capacity, depending upon the mix between the authorized Moderna COVID-19 vaccine at the 100 μg dose level and potentially lower doses of the Company’s variant booster candidates and pediatric vaccines, if authorized, according to a news release.

Get the full story at our sister site, Pharmaceutical Processing World.

Moderna pledges to manufacture up to 3B COVID-19 vaccine doses in 2022

Moderna (NSDQ:MRNA) announced today that it committed funds to increase its COVID-19 vaccine manufacturing capacity to up to 3 billion doses for 2022.

Cambridge, Mass.-based Moderna’s new funding commitments are slated to increase supply at its owned and partnered manufacturing facilities up to that 3 billion-dose capacity, depending upon the mix between the authorized Moderna COVID-19 vaccine at the 100 μg dose level and potentially lower doses of the Company’s variant booster candidates and pediatric vaccines, if authorized, according to a news release.

The company said it plans to use its existing cash balance to fund the investments into the increased manufacturing, which will see the doubling of drug substance manufacturing at Lonza’s Switzerland-based facility, more than double the formulation, fill/finish and drug substance manufacturing at Rovi’s Spain facility and a 50% increase in drug substance at Moderna’s U.S. plants.

Interest in COVID-19 vaccine boosters on the upswing

Pfizer-BioNTech vaccine image courtesy of Wikipedia

Signs are growing that COVID-19 vaccine boosters will be required to fight waning immunity and SARS-CoV-2 variants.

An article recently published in NEJM describes how SARS-CoV-2 variants managed to cause breakthrough infection in two patients fully immunized with mRNA vaccines. The 15 authors support “efforts to advance a new vaccine booster (as well as a pan-coronavirus vaccine) to provide increased protection against variants.”

While such breakthrough infections remain rare, they may grow more common as immunity from vaccines wanes. Data suggests that mRNA vaccines offer strong protection for at least six months. It is likely that immunity will wane sometime in another six to 12 months.

Pfizer CEO Dr. Albert Bourla has said that boosters of the vaccine will likely be necessary, as did BioNTech cofounders Dr. Ugur Sahin and Dr. Özlem Türeci.…

Boston Scientific, Stryker may get extension on Medicare payments

CMS has issued a proposal for the 2022 fiscal year that would potentially help big medtech companies like Boston Scientific and Stryker.

Released yesterday, the proposal for the Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) offers updated Medicare payment policies and rates for operating and capital-related costs of acute care hospitals and for certain hospitals and hospital units excluded from the IPPS for fiscal 2022.

CMS’ aim for the proposal is to close healthcare equity gaps and support greater access to certain diagnostics nad therapies during the ongoing public health emergency brought on by COVID-19 and beyond.

Within the proposal is a list of technologies that would receive an additional year of new technology add-on payments (NTAP), which includes devices from Boston Scientific and Stryker, among several other medtech companies.

Boston Scientific’s E…

Abbott sees a future for at-home diagnostics after COVID-19

The BinaxNow COVID-19 Ag Card [Image courtesy of Abbott]Abbott CEO Robert B. Ford has suggested that at-home diagnostics could be here to stay even after the COVID-19 pandemic.

Speaking on Abbott’s April 20 earnings call, transcribed by SeekingAlpha, Ford pointed out that the company’s diagnostics sales increased by 115% year-over-year from the first quarter of 2020, with a significant chunk of that made up by COVID-19 testing revenues.

Those COVID-19 testing-related sales were spearheaded by Abbott’s rapid, point-of-care test offerings, which include the BinaxNOW card that earlier this month became available over the counter. Ford cited a trend in demand that is shifting toward rapid testing around the world.

“During the quarter, BinaxNOW received U.S. emergency use authorization for over-the-counter nonprescription self-use for people with or without symptoms,” Ford said. “We began shipping test kits to major retailers …

New therapy could protect lung function in COVID-19 and flu patients

[Image courtesy of CDC]

One of the most dangerous aspects of the novel coronavirus is its potential to cause pneumonia and acute respiratory distress syndrome (ARDS). Pandemic influenza A (H1N1) can cause similar problems.

A team of researchers at Ohio State University has developed a potential treatment for ARDS stemming from COVID-19 or influenza.

The inspiration for the therapy, which they tested in mice, resulted in an observation that influenza-infected mice had lower levels of liponucleotides, which are involved in the production of surfactant in the lungs. Pulmonary surfactants support normal lung function, preventing them from partially or fully collapsing.

The researchers administered liponucleotides to influenza-infected mice via both injection and orally. Their blood oxygen levels returned to normal while inflammation decreased.

“The most important and impressive thing in this …

Study: Single dose of Pfizer or AstraZeneca COVID-19 vaccine cuts infection risk by 65%

[Photo by Daniel Schludi on Unsplash]

One dose of vaccine from Pfizer (NYSE:PFE) or AstraZeneca (LON:AZN) leads to a substantial reduction in infection risk in adults, according to a recent study published in BMJ.

The study organizers found that recipients of a single dose of either vaccine led to a 57% reduction in asymptomatic infections and a 74% drop in symptomatic disease at least 21 days after vaccination. The overall risk reduction was thus 65%.

A second dose of the vaccine from Pfizer and its partner BioNTech (NSDQ:BNTX) reduced the risk of infection by 70% in the study. There was insufficient data to assess the efficacy of the AstraZeneca vaccine after the second dose.

The researchers concluded that when vaccine supplies are limited, health systems should prioritize vaccinating those who have not yet been infected with COVID-19 while prioritizing giving second doses to those 60 and o…

U.S. to donate 60M doses of AstraZeneca’s COVID-19 vaccine

The Biden administration announced today that it will begin sharing its store of AstraZeneca’s COVID-19 vaccine following safety reviews.

Once the vaccine clears federal safety reviews, 60 million doses of the vaccine are expected to be made available, according to a Tweet from senior White House advisor Andy Slavitt.

“BREAKING: U.S. to release 60 million Astra Zeneca doses to other countries as they become available,” Slavitt wrote on the social media platform.

Get the full story at our sister site, Pharmaceutical Processing World.

U.S. to donate 60M doses of AstraZeneca’s COVID-19 vaccine

The Biden administration announced today that it will begin sharing its store of AstraZeneca’s COVID-19 vaccine following safety reviews.

Once the vaccine clears federal safety reviews, 60 million doses of the vaccine are expected to be made available, according to a Tweet from senior White House advisor Andy Slavitt.

“BREAKING: U.S. to release 60 million Astra Zeneca doses to other countries as they become available,” Slavitt wrote on the social media platform.

He followed the initial announcement with a reply, saying “to everyone who understandably says: ‘about time’ or ‘what were they waiting for’, at this time there are still very few available. No real time has been lost.”

The Associated Press, which was first to report the news, said the decision expands upon Biden’s earlier promise to share 4 million doses of the vaccine with Mexico and Canada.

According to the AP report, th…

More than 5 million skipped getting second COVID-19 vaccine dose

Image courtesy of Wikipedia

The percentage of people who failed to get the second dose of Pfizer or Moderna COVID-19 vaccines is growing, according to recent CDC data. Some five million people, or almost 8% of people who got the first vaccine dose, missed getting the second.

In mid-March, 3% of people were overdue for their second dose.

People who missed getting their second vaccine dose provided several explanations. Some wanted to avoid adverse events, which are more common after the second dose. Others believed a single dose offered sufficient protection.

Get the full story from our sister site, Pharmaceutical Processing World.