Tag: vaccines

Batch-dependent safety of the BNT162b2 mRNA COVID-19 vaccine

Mary Pat Campbell

Link: https://onlinelibrary.wiley.com/doi/full/10.1111/eci.13998

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Excerpt:

Vaccination has been widely implemented for mitigation of coronavirus disease-2019 (Covid-19), and by 11 November 2022, 701 million doses of the BNT162b2 mRNA vaccine (Pfizer-BioNTech) had been administered and linked with 971,021 reports of suspected adverse effects (SAEs) in the European Union/European Economic Area (EU/EEA).1 Vaccine vials with individual doses are supplied in batches with stringent quality control to ensure batch and dose uniformity.2 Clinical data on individual vaccine batch levels have not been reported and batch-dependent variation in the clinical efficacy and safety of authorized vaccines would appear to be highly unlikely. However, not least in view of the emergency use market authorization and rapid implementation of large-scale vaccination programs, the possibility of batch-dependent variation appears worthy of investigation. We therefore examined rates of SAEs between different BNT162b2 vaccine batches administered in Denmark (population 5.8 million) from 27 December 2020 to 11 January 2022.

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A total of 7,835,280 doses were administered to 3,748,215 persons with the use of 52 different BNT162b2 vaccine batches (2340–814,320 doses per batch) and 43,496 SAEs were registered in 13,635 persons, equaling 3.19 ± 0.03 (mean ± SEM) SAEs per person. In each person, individual SAEs were associated with vaccine doses from 1.531 ± 0.004 batches resulting in a total of 66,587 SAEs distributed between the 52 batches. Batch labels were incompletely registered or missing for 7.11% of SAEs, leaving 61,847 batch-identifiable SAEs for further analysis of which 14,509 (23.5%) were classified as severe SAEs and 579 (0.9%) were SAE-related deaths. Unexpectedly, rates of SAEs per 1000 doses varied considerably between vaccine batches with 2.32 (0.09–3.59) (median [interquartile range]) SAEs per 1000 doses, and significant heterogeneity (p < .0001) was observed in the relationship between numbers of SAEs per 1000 doses and numbers of doses in the individual batches. Three predominant trendlines were discerned, with noticeable lower SAE rates in larger vaccine batches and additional batch-dependent heterogeneity in the distribution of SAE seriousness between the batches representing the three trendlines (Figure 1). Compared to the rates of all SAEs, serious SAEs and SAE-related deaths per 1.000 doses were much less frequent and numbers of these SAEs per 1000 doses displayed considerably greater variability between batches, with lesser separation between the three trendlines (not shown).

Author(s): Max Schmeling, Vibeke Manniche, Peter Riis Hansen

Publication Date: 30 Mar 2023

Publication Site: European Journal of Clinical Investigation

A Potential COVID Game-Changer

Mary Pat Campbell

Link:https://www.dailyposter.com/a-potential-covid-game-changer/

Excerpt:

Progressive lawmakers are calling on President Joe Biden to take advantage of the fact that the U.S. Army’s new pan-coronavirus vaccine recipe is not restricted by intellectual property restrictions and share the information with the world.

According to the Army, early research shows that the Spike Ferritin Nanoparticle (SpFn) vaccine, developed by scientists at the Walter Reed Army Institute of Research, can “provide broad protection” against COVID-19 and future variants. The SpFn vaccine must still undergo Phase 2 and 3 of human trials, but if it proves successful, distributing the new vaccine around the globe could be a game-changer in the fight against the COVID pandemic.

Author(s): WALKER BRAGMAN, ANDREW PEREZ

Publication Date: 1 Feb 2022

Publication Site: Daily Poster

Biden Could Share Vaccine Data With The World

Mary Pat Campbell

Link: https://www.dailyposter.com/biden-could-share-vaccine-data-with-the-world/

Excerpt:

Wealthy, vaccine manufacturing countries like Germany, France, and the U.S. have pledged to fully vaccinate their own populations while also sharing doses with the developing world. But it’s not clear that a sufficient number of doses currently exist for them to make good on this promise. The European Union, for example, is on track to fall far short of its goal of donating 200 million doses to non-member states by the end of the year. And as of August, COVAX, the World Health Organization’s (WHO) vaccine sharing initiative, had distributed 188 million vaccines worldwide, just 19 percent of the 1.1 billion that the WHO says are needed to end the pandemic.

The more people remain unvaccinated worldwide, the likelier it is that new variants will emerge, endangering vaccinated and unvaccinated alike.

The Biden administration’s strategy for expanding worldwide vaccine access has largely relied on pushing for vaccine patent waivers through negotiations at the World Trade Organization. But those negotiations have been stymied by strong opposition from member states of the European Union, meaning that unilateral American action may be necessary to expand vaccine access on the necessary scale.

Legally, the U.S. may already have the ability to do so. The terms between Moderna and the federal government specify that the government possesses rights to the vaccine technology developed under the contract, meaning that it can unilaterally publish or share the data with anyone. Furthermore, an essential component of the Moderna vaccine was invented and patented by U.S. government researchers, meaning that the government could threaten a patent infringement suit against Moderna if the company refuses to share its vaccine know-how.

Author(s): Sam Mellins

Publication Date: 7 September 2021

Publication Site: The Daily Poster

Comparing the COVID-19 Vaccines: How Are They Different?

Mary Pat Campbell

Link: https://www.yalemedicine.org/news/covid-19-vaccine-comparison

Excerpt:

In the United States, the number of cases and deaths that had been rising to a peak for almost a year have been flattening out, thanks, in large part, to COVID-19 vaccinations that began in December. As the weeks pass, more reports have been coming out about the effectiveness of the vaccines that are in use and the potential of those still in development. So, how do they differ? 

It’s important to keep up, but it’s also a daunting task, given the flood of information (and misinformation) coming at us from so many directions.

Vaccines from Pfizer-BioNTech, Moderna, and Johnson & Johnson are being administered in the U.S. right now, and others are on track to do the same. 

We mapped out a comparison of the most prominent COVID-19 vaccines.

Author(s): Kathy Katella

Publication Date: 1 July 2021 (originally published February 2021, updated)

Publication Site: Yale Medicine

The big hole in America’s plan to fight Covid-19 variants

Mary Pat Campbell

Link: https://www.politico.com/news/2021/04/07/covid-variants-drug-manufacturing-479902

Excerpt:

Vaccine makers like Pfizer, Moderna and Johnson & Johnson coped with intense global demand for their original shots by manufacturing millions of doses while the vaccines were still in clinical trials. But that is not an option now, because the companies are still racing to fulfill orders for their existing Covid-19 vaccines — and some, including Johnson & Johnson and AstraZeneca, are struggling with major production setbacks. Pumping out second-generation shots would require factories to switch over manufacturing lines now used for the first wave of vaccines, and in some cases fire up new production processes.

The potential manufacturing gap is the latest challenge to President Joe Biden’s promise to bring the pandemic to a close. South Africa has already rejected AstraZeneca’s vaccine because an early trial showed it wasn’t effective against the B.1.351 strain that dominates there and has now reached the United States. Another variant spreading in America — P.1, first found in Brazil — has raised similar concerns about its ability to evade some of the vaccines now in use globally. Biden administration officials are working overtime to understand how the variants’ spread could alter vaccination strategies. But the lack of manufacturing capacity is limiting America’s options.

Author(s): SARAH OWERMOHLE

Publication Date: 7 April 2021

Publication Site: Politico

CDC Launches New COVID Vaccine Finder Tool

Mary Pat Campbell

Link: https://magazine.northeast.aaa.com/daily/life/health-fitness/cdc-covid-vaccine-finder-tool/

Excerpt:

With news that the single dose Johnson & Johnson vaccine has met U.S. Food and Drug Administration requirements, vaccination is once again front and center in many Americans’ minds.

The Centers for Disease Control and Prevention has released a vaccine finder tool to help you locate vaccine distribution sites. The tool populates the name, address and phone number of pharmacies and stores within a one to 50-mile radius of your zip code.

At this time, users can search for the Moderna, Pfizer-BioNTech and/or Johnson & Johnson’s Janssen COVID vaccines and see whether specific locations are in or out of stock.

Author(s): DALLAS ERNST

Publication Date: 26 February 2021

Publication Site: AAA

What Do Vaccine Efficacy Numbers Actually Mean?

Mary Pat Campbell

Link: https://www.nytimes.com/interactive/2021/03/03/science/vaccine-efficacy-coronavirus.html

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Excerpt:

Efficacy depends on the details of a trial, such as where it took place. Johnson & Johnson ran trials at three sites: in the United States, Latin America and South Africa. The overall efficacy was lower than that in the United States alone. One reason for that appears to be that the South Africa trial took place after a new variant had swept across that country. Called B.1.351, the variant has mutations that enable it to evade some of the antibodies produced by vaccination. The variant didn’t make the vaccine useless, however. Far from it: In South Africa, Johnson & Johnson’s efficacy was 64 percent.

Efficacy can also change when scientists look at different outcomes. Johnson & Johnson’s vaccine had an 85 percent efficacy rate against severe cases of Covid-19, for example. That’s important to know, because it means that the vaccine will prevent a lot of hospitalizations and deaths.

Author(s): Carl Zimmer, Keith Collins

Publication Date: 3 March 2021

Publication Site: New York Times

Doses of AstraZeneca’s Covid-19 Vaccine Pile Up in Europe Amid Government Restrictions

Mary Pat Campbell

Link: https://www.wsj.com/articles/doses-of-astrazenecas-covid-19-vaccine-pile-up-in-europe-amid-government-restrictions-11614715968

Excerpt:

Europe’s reluctance to distribute millions of doses of AstraZeneca PLC’s Covid-19 vaccine is coming under pressure after the French government authorized use of the shot for some older people.

The French government announced it would allow people with comorbidities between the ages of 65 and 74 to receive the vaccine developed by Oxford University and AstraZeneca. New data from the U.K. on Monday showed just one dose of the vaccine was effective in preventing disease and deaths among adults aged 70 and older who had received it.

France’s move was a sharp departure from a month ago when President Emmanuel Macron told reporters that the vaccine was quasi ineffective for people older than 65, without providing evidence to back up his claim. The comments helped sow doubts across the European Union that still persist.

Author(s): Stacy Meichtry, Bojan Pancevski

Publication Date: 2 March 2021

Publication Site: Wall Street Journal

Finicky COVID-19 vaccines raise the stakes of power outages

Mary Pat Campbell

Link: https://www.theverge.com/science/2021/2/16/22285394/covid-vaccine-power-outage-freezer?mc_cid=cd30d3af2c&mc_eid=983bcf5922

Excerpt:

Winter storms paralyzing the United States have left millions without power and sent health officials scrambling to protect freezers full of COVID-19 vaccines, which have to be kept at extremely low temperatures or risk going bad.

Rolling blackouts through Texas took out at least one set of freezers full of the Moderna vaccine; 5,000 doses were sent to a university, a jail, and a handful of hospitals before they expired. The Oregon Health Authority is moving vaccines to places with power, although the agency isn’t disclosing which storage sites have their systems down. As part of its storm preparations, Kentucky made sure places holding COVID-19 vaccines had contingency plans.

Author(s): Nicole Wetsman

Publication Date: 16 February 2021

Publication Site: the Verge