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Is J&J’s COVID-19 vaccine linked to tinnitus?

In Johnson & Johnson’s (NYSE:JNJ) Phase 3 trial for the Ad26.COV2.S COVID-19 vaccine, six vaccine recipients developed tinnitus or ringing in the ears.

In five of those individuals, tinnitus had either resolved or was resolving. The condition was unresolved in the other trial volunteer.

No placebo recipients developed the condition.

J&J concluded that the tinnitus reports were likely unrelated to the vaccine. The principal investigator in the trial that two of the events were related and the remainder unrelated.

A 21-year-old volunteer involved in an earlier clinical trial for the J&J vaccine developed tinnitus and sudden hearing loss 34 days after receiving the vaccine. The patient recovered 69 days after receiving the injection. Johnson & Johnson also determined that the event was unrelated to the vaccine.

In all, some 43,783 volunteers participated in the Phase 3 trial. A total of 19,630 participants received the Ad26.COV…

What made rapid mRNA COVID-19 vaccine development possible

Vials containing the Moderna COVID-19 vaccine. Image from Wikipedia.

A segment of the population is wary of COVID-19 vaccines. One of the main reasons why is the rapid pace at which they were developed.

But the mRNA vaccines FDA was able to authorize in late 2020 were years in the making, stressed Kizzmekia Corbett of the NIH at CDC’s National Forum on COVID-19 Vaccine virtual event.

The traditional vaccine development process, which typically spans years, was “shortened, but no integrity was lost,” Corbett said.

Scientists at the NIH have studied coronaviruses for several years, said Corbett, who leads a research team there focused on coronavirus vaccines.

One central factor driving the rapid development of mRNA COVID-19 vaccines was the collaboration between laboratories, institutions and companies across the globe.

“And then secondly, there was extensive work on MERS and other …

FDA prioritizes quick trials for variant-specific COVID-19 vaccines

FDA has released updated guidance detailing its plans to streamline authorization of COVID-19 vaccines adapted to more-infectious variants, such as the U.K. variant B.1.1.7, which is now present in dozens of states.

FDA’s guidance would require such companies to launch small clinical studies similar to those needed for annual flu vaccines.

It also encourages sponsors to test modified vaccines in unvaccinated as well as previously-vaccinated individuals.

“The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” said Acting FDA Commissioner Dr. Janet Woodcock in a statement.

Recent data suggest that variant B.1.429, initially found in California, is also more infectious than earlier lineages.

Complicating matters further, B.1.1.7 and B.1.429 have merged in a recombination process to create a new hybrid. Other kno…

FDA issues guidelines to address COVID-19 variants

SARS-CoV-2 image from Wikipedia

The FDA today issued guidance for medical product developers to address the emergence of variants of SARS-CoV-2, which causes COVID-19.

Variants of the virus have been detected in multiple countries across the globe, including the U.S., and they pose a major threat to potentially ending the COVID-19 pandemic as protocols such as mask-wearing and hand-washing remain in place and vaccines are being distributed.

“The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” acting FDA Commissioner Dr. Janet Woodcock said in a news release. “We know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the performance of these products. By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this …

MedTech 100 roundup: Rise to new heights continues

The medtech industry hit another high as 2021 continues to bring strong performances out of some of the biggest companies around.

MassDevice‘s MedTech 100 index ended the week (Feb. 12) at 110.63 points, marking a 2.2% rise from the 108.23-point mark set at the end of the previous week (Feb. 5).

The final mark for the week sets an all-time best for the index, which had previously reached 106.81 points on Jan. 8, then 107.4 points on Jan. 20 before besting itself again with last week’s finish. The rise has been considerably impressive given that the index had never reached even the 100-point mark before November 2020.

Medtech’s latest rise means the index has risen 19.8% from the pre-COVID-19 pandemic high of 92.32, set on Feb. 19, 2020. Additionally, the industry has very much rebounded from its lowest place, a 62.13-point mark at the start of the pandemic on March 23, 2020. Since that point, the industry has jumped 78.1%.

Medtech’s performa…

Feds order 200M more vaccine doses from Pfizer, Moderna

[Photo by Daniel Schludi on Unsplash]

U.S. government agencies announced that they purchased a total of 200 million additional doses of COVID-19 vaccines from Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA).

The orders of 100 million doses from each of the only two FDA-authorized vaccines in the U.S. were made by the U.S. Health & Human Services Dept. (HHS) and the Defense Dept. (DoD). The U.S. has now purchased a total of 600 million doses, according to a news release, with the totals of the two-dose vaccines allowing for the vaccination of 300 million people.

Get the full story at our sister site, MassDevice.

Feds order 200M more vaccine doses from Pfizer, Moderna

[Photo by Daniel Schludi on Unsplash]U.S. government agencies announced that they purchased a total of 200 million additional doses of COVID-19 vaccines from Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA).

The orders of 100 million doses from each of the only two FDA-authorized vaccines in the U.S. were made by the U.S. Health & Human Services Dept. (HHS) and the Defense Dept. (DoD). The U.S. has now purchased a total of 600 million doses, according to a news release, with the totals of the two-dose vaccines allowing for the vaccination of 300 million people.

Each company is set to deliver 300 million doses in regular increments through the end of July 2021 while leveraging U.S.-based manufacturing capacity to produce in bulk.

“As the President directed, we are expanding our supply of COVID vaccines to protect people as quickly as possible,” Acting HHS Secretary Norris Cochran said in the release. “These purchases will allow us to accelerate our vaccination …

Several EU nations recommend older adults avoid AstraZeneca COVID-19 vaccine

Portugal health authorities recently recommended that AstraZeneca’s (LON:AZN) COVID-19 vaccine not be used for those who are over 65.

South Africa recently paused its deployment of the vaccine over worries that it is ineffective against a variant circulating there.

In addition to Portugal, several European countries have expressed reservations about the vaccine’s efficacy in older populations. France, Norway, Germany, Austria and others have decided to only administer the vaccine to those under 65. Poland has reserved the vaccine for those 60 and under, while Spain and Italy have recommended for recipients under 55.

The reservations of the E.U. nations stems in large from a data shortage. Two patients over 65 in the AstraZeneca trial contracted the virus, making it difficult to draw firm conclusions about its efficacy in that age group. There were 660 patients over 65 in the trial.

Portugal has had 765,000 COVID-19 cases and more than 14,000 d…

Which companies will likely produce the most COVID-19 vaccine in 2021?

Photo by Markus Spiske on Unsplash

Since the beginning of the pandemic, much of society has pinned its hopes on the availability of a vaccine. Now that several are available across the world, there is hope, said Dr. Anthony Fauci, chief medical advisor to President Joe Biden, in a recent JAMA interview. “There’s light at the end of the tunnel.”

One thing that will make the light at the end of the tunnel brighter as we head into the spring is the greater availability of vaccine doses. “The discordance between supply and demand will be diminished,” Fauci said.

The roster of companies producing vaccines is steadily increasing, making it possible to vaccinate a substantial portion of the world’s population this year. (Note: Most of the companies in this list have two-dose vaccines.)

Here’s a roundup of notable companies’ production targets for 2021:

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

Which companies will likely produce the most COVID-19 vaccine in 2021?

Photo by Markus Spiske on Unsplash

Since the beginning of the pandemic, much of society has pinned its hopes on the availability of a vaccine. Now that several are available across the world, there is hope, said Dr. Anthony Fauci, chief medical advisor to President Joe Biden, in a recent JAMA interview. “There’s light at the end of the tunnel.”

One thing that will make the light at the end of the tunnel brighter as we head into the spring is the greater availability of vaccine doses. “The discordance between supply and demand will be diminished,” Fauci said.

The roster of companies producing vaccines is steadily increasing, making it possible to vaccinate a substantial portion of the world’s population this year. (Note: Most of the companies in this list have two-dose vaccines.)

Here’s a roundup of notable companies’ production targets for 2021:

AstraZeneca and Oxford University: Up to 3…

COVID-19-free Palau could be among the first to reach herd immunity

[Photo by Fusion Medical Animation on Unsplash]

To date, in the U.S., some 6.5% of the population has received at least one COVID-19 vaccine dose. Alaska is currently the frontrunner in vaccinating its population. Almost 12% of Alaskans have received at least one dose.

But two U.S.-linked countries — Palau and American Samoa — have vaccinated more people per capita than any U.S. state. More than 17% of the inhabitants of Palau, a cluster of more than 500 islands east of the Philippines, have received at least one dose. For American Samoa, the same figure is 14.6%.

The U.S. territories, Guam and the Northern Mariana Islands have also administered more COVID-19 vaccine doses per capita than any U.S. state other than Alaska and West Virginia.

Palau (population 18,000) is noteworthy in that it has reported no COVID-19 cases to the World Health Organization. Neither had American Samoa.

Like Is…

BREAKING: J&J’s Phase 3 COVID-19 vaccine study results raise more alarms about new variants

Johnson & Johnson (NYSE:JNJ) announced results from its COVID-19 vaccine trial that show decreased effectiveness against new virus variants.

The vaccine candidate from Johnson & Johnson’s Janssen Pharmaceutical Companies, which was 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination, proved less effective in South Africa, where a new variant of the virus has appeared, offering just 57% protection from moderate-to-severe infection there (where 95% of cases were due to infection from the variant). The level of protection in the U.S. was 72% and it was 66% in Latin America.

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