Talk:Pfizer–BioNTech COVID-19 vaccine

Extended-confirmed-protected edit request on 19 August 2021

Please add

"The spike protein generated endogenously by the vaccine could also negatively impact the male testes, as the ACE2 receptor is highly expressed in Leydig cells in the testes (Verma et al., 2020)."

source: https://ijvtpr.com/index.php/IJVTPR/article/view/23/51 88.8.63.78 (talk) 15:22, 19 August 2021 (UTC)

 Not done for now: please establish a consensus for this alteration before using the {{edit extended-protected}} template. This source does not appear reliable, as it is a predatory publisher. ScottishFinnishRadish (talk) 15:31, 19 August 2021 (UTC)

Not done: Further misinformation. Authors are a 'computer scientist' and 'naturopathic oncologist' (not a medical scientist and not a medical doctor, but a charlatan engaging in pseudoscience). Survey of available evidence dated after the linked 'paper' asserts no evidence in support of the thesis.Melmann 15:56, 19 August 2021 (UTC)

that's an authority argument https://en.wikipedia.org/wiki/Argument_from_authority#:~:text=An%20argument%20from%20authority%20(argumentum,evidence%20to%20support%20an%20argument.

Please tell why this paper is wrong with a reliable source

By the way, the "factchecker" says "VERDICT No evidence. As of this article’s publication, there is no evidence the mRNA COVID-19 vaccines affect men’s sperm."

The statement is about testes, not sperm.— Preceding unsigned comment added by 88.8.63.78 (talk)

IP, what you are recommending is called original research, as it makes claims that are not supported by reliable secondary medical sources. We cannot add information that may mislead our readers, especially when it comes to matters of health.— Shibbolethink ^{(♔ ♕)} 15:18, 26 August 2021 (UTC)

Magnetism

The section on magnetism is not specific to the Pfizer vaccine and includes many other vaccine manufacturers. The magnetism claims are already in the Wikipedia page on Covid misinformation.

The magnetism content should be included on all vaccine brands, or it should be removed from the this Pfizer page (the better option). YeshuaAdoni (talk) 07:50, 27 August 2021 (UTC)

YeshuaAdoni, why? That's not how WP:DUE works. — Shibbolethink ^{(♔ ♕)} 10:42, 27 August 2021 (UTC)

Why have this information here? I don't see this info on Moderna or any other Wikipedia page on Covid vaccines. YeshuaAdoni (talk) 10:51, 27 August 2021 (UTC)

YeshuaAdoni, If there are sources which discuss it, then we should add it in those articles as well. — Shibbolethink ^{(♔ ♕)} 10:54, 27 August 2021 (UTC)

I have added the magnetism passage to the J&J and Moderna vaccines, so now it is at the 3 most implicated vaccine articles. I have also added MEDRS compliant sources. — Shibbolethink ^{(♔ ♕)} 11:10, 27 August 2021 (UTC)

Problematic wording in the first sentences of the LEAD?

This was the line in the top paragraph:

The German company BioNTech is the developer of the vaccine, and partnered for support with clinical trials, logistics and manufacturing with American company Pfizer[18][19] as well as Chinese company Fosun in China, Hong Kong, and Macau.[20][21][22]

Below was what the article said after that, which is a true statement:

BioNTech, a German company, developed the vaccine and collaborated with Pfizer, an American company, for support with clinical trials, logistics, and manufacturing. In China, BioNTech is partnered with China-based Fosun Pharma for development, marketing, and distribution rights and the vaccine is colloquially described as the Fosun–BioNTech COVID‑19 vaccine.[24][25][26][27][28][29][30]

Then, it was changed into below, and references to China partnership etc. are removed:

For its development BioNTech collaborated with Pfizer, an American company, for support with clinical trials, logistics, and manufacturing.

To basically give the subliminal message that BionTech vaccine itself was developed with Pfizer help, while it is clearly not the case, and that Pfizer collaborated in clinical testing, manufacturing and distribution.— Preceding unsigned comment added by 88.230.174.176 (talk) 23:15, 1 September 2021 (UTC)

"clinical testing, manufacturing" is typically what is meant by "development" in the pharmaceutical industry, so the latest wording makes sense to me. See Drug development particularly the sections on "pre-clinical" and "clinical development". The overall phases of the industry are: Research → Development → Distribution → Marketing.— Shibbolethink ^{(♔ ♕)} 23:18, 1 September 2021 (UTC)

Did they test >30mcg doses and >21 days already in year 2020? What were the results?

I know Pfizer tested larger doses than 30mcg in year 2020.

What were the results? More antibodies after 2 doses? Which could mean better efficacy.

Did they also test longer intervals than 21 days?

Why Moderna decided on 100mcg and 28 days?

--ee1518 (talk) 14:00, 4 September 2021 (UTC)

Article name

Per Wikipedia policy should not this article now be renamed to "tozinameran"? Policy: https://en.wikipedia.org/wiki/Wikipedia:WikiProject_Pharmacology/Style_guide#Article_name David G (talk) 04:49, 6 September 2021 (UTC)

@DavidCWG: please go through the discussion Talk:Pfizer–BioNTech_COVID-19_vaccine#Requested_move_3_July_2021. 2402:3A80:6EC:4EEA:C965:CC18:764C:C847 (talk) 14:18, 6 September 2021 (UTC)

Ultracold storage requirements

The storage requirements have been updated several times and but much of this article hasn't kept up with those revisions. For example, I don't think this snippet is true anymore:

Low-income countries have limited cold chain capacity for ultracold transport and storage of a vaccine. The necessary storage temperatures for the vaccine are much lower than for the similar Moderna vaccine. The head of Indonesia's Bio Farma Honesti Basyir said purchasing the vaccine is out of the question for the world's fourth-most populous country, given that it did not have the necessary cold chain capability. Similarly, India's existing cold chain network can handle only temperatures between 2 and 8 °C (36 and 46 °F), far above the requirements of the vaccine.

Vaccine for children 5-11 y/o

"Specific populations" new information:

Pfizer has conducted a clinical trial of 2200 children aged 5-11, announcing that it has generated a "robust" response and is safe. They expect to submit the to the FDA and other US health agencies soon. Tanaya001 (talk) 00:21, 21 September 2021 (UTC)

 Done Thanks ! Alexcalamaro (talk) 05:09, 1 October 2021 (UTC)

Extended-confirmed-protected edit request on 21 September 2021

Please change "it's" to "its" in the first sentence.

The Pfizer–BioNTech COVID-19 vaccine (INN: tozinameran), sold under the brand name Comirnaty,[3][5] is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech and for it's development collaborated with American company Pfizer, for support with clinical trials, logistics, and manufacturing.[20][21] Joelvontreifeldt (talk) 23:03, 21 September 2021 (UTC)

 Done Thank you — LauritzT (talk) 11:21, 22 September 2021 (UTC)

Two issues, approved vs authorized and two different vaccines

1. It seems this article use the words approved and authorized without distinction, while these are two different things, at least for the FDA. For example "It is authorized for use in people aged twelve years and older in some jurisdictions". Authorized is basically the emergency authorization while approved is the final approval.
2. The Pfizer–BioNTech COVID-19 vaccine are actually TWO legally different vaccines with "certain differences". One is approved while the other is just authorized. This was the info I came to the article to read about, but found nothing about it.
   1. How is Comirnaty (COVID-19 Vaccine, mRNA) related to the Pfizer-BioNTech COVID-19 Vaccine? The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA), made by Pfizer for BioNTech and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns
   2. The products are legally distinct with certain differences that do not impact safety or effectiveness.
   3. This has caused some legal challanges regarding mandated vaccination since one is approved and the other is just authorized. — Preceding unsigned comment added by 85.226.160.99 (talk) 07:42, 14 October 2021 (UTC)

References

95.6% into estimate 96% efficacy

So I was wondering that the additional efficacy rate 4 days ago. Can you explain that booster shot efficacy rate? [1] Abrilando232 (talk) 02:05, 26 October 2021 (UTC)

I added a brief mention to this result. --Fernando Trebien (talk) 12:33, 10 November 2021 (UTC)

Extended-confirmed-protected edit request on 3 November 2021

73.141.181.50 (talk) 00:33, 3 November 2021 (UTC)

Vaccine in the United States 5 and older instead of 12 and older.

 Not done This is not yet true, it still requires the ACIP to weigh in and the CDC director to approve it. Come back when that happens — Shibbolethink ^{(♔ ♕)} 01:15, 3 November 2021 (UTC)

"Data integrity issues"

I've moved the following text here, which was earlier in the top-level COVID-19 vaccine article:

“ On 2 November 2021, the peer-reviewed journal The BMJ reported "data integrity issues" in the activities of one company involved in the phase III evaluation trials of the Pfizer vaccine. ”

While concerning, as far as I am aware this does not seem to invalidate the overall results of the trial, and still less does it influence the overall issue of COVID-19 vaccine efficacy, and it shouldn't be given excess importance.

-- The Anome (talk) 13:59, 3 November 2021 (UTC)

Hm.. I was wondering about this as well. Should we add this to the article or should we wait for more information? Mrconter1 (talk) 08:59, 10 November 2021 (UTC)

Nevermind. It has been addressed. Mrconter1 (talk) 09:00, 10 November 2021 (UTC)

— "The report was enthusiastically embraced by anti-vaccination activists"

This report was discussed by CDC, Financial Times and worldwide organizations concerned about the data. It's not a matter of anti or pro-vax battle. 1ozieje (talk) 03:54, 19 November 2021 (UTC)

References

You should have discussed this sentence here before deleting it.

While concerning, It's not about being concerning or not. It's about presenting all relevant information.

as far as I am aware this does not seem to invalidate the overall results of the trial, and still less does it influence the overall issue of COVID-19 vaccine efficacy, The quote does not question the overall results or efficacy.

and it shouldn't be given excess importance. One sentence is not excess importance. If you want to lower its importance, move it from the lede to a section.

Deleting material simply because someone with whom you disagree (the "anti-vaxxer" boogieman) might agree with it is not appropriate and is clear WP:POV. This article should present all facts about the vaccine. Isabela31 (talk) 20:13, 19 November 2021 (UTC)

On 2 November 2021, The BMJ published a piece by journalist Paul D. Thacker alleging there has been "poor practice" at Ventavia, one of the companies involved in the phase III evaluation trials of the Pfizer vaccine. The report was enthusiastically embraced by anti-vaccination activists. Commenting on Thacker's work in Science-Based Medicine, David Gorski wrote that his article presented facts without necessary context to misleading effect, playing up the seriousness of the noted problems.

The report was enthusiastically embraced by anti-vaccination activists. This sentence is irrelevant and unsourced. It should be deleted on both counts. Even if it was sourced, it would be irrelevant. Its only purpose is to tell the reader to be skeptical of the previous sentence, making it WP:POV.

Science-Based Medicine is not WP:MEDRS. The blog post from the website is not WP:MEDRS. The sentence has no place in this article and should be deleted. Isabela31 (talk) 21:06, 19 November 2021 (UTC)

"This sentence is irrelevant and unsourced" ← false. The question of an investigative journalist over-egging stuff is not a WP:MEDRS question and SBM is a perfect source for independent commentary on journalistic crankery. Alexbrn (talk) 21:09, 19 November 2021 (UTC)

References

Efficacy in 75+

According to the "Vaccine efficacy against confirmed symptomatic COVID‑19" table, "Age ≥75" group, the 95% CI for efficacy includes negative numbers, which is impossible. Someone please fix this. --Isabela31 (talk) 18:26, 12 November 2021 (UTC)

I looked up the source. The data is from Table 10 in the source. This is what the source report is showing: a probability whose CI includes negative values!

What is the Wikipedia policy on this, if a citeable source is obviously wrong? --Isabela31 (talk) 00:53, 14 November 2021 (UTC)

Why is it obviously wrong? Confidence intervals cross zero sometimes, it is generally a sign that the data set is small, which certainly seems to be the case for the 75 and over group in that paper. MrOllie (talk) 21:34, 19 November 2021 (UTC)

If the quantity in question cannot be negative, neither its point estimate or its CI or any of its distribution can be negative. This quantity cannot be negative. Putting a probability on negative values for this quantity is an obvious error. Someone used an incorrect calculation that did not account for the fact that the quantity cannot be negative. Garbage in garbage out. Isabela31 (talk) 21:56, 19 November 2021 (UTC)

Okay, so it's not "obviously" wrong, but just "wrong according to Isabela31". Better seek consensus on what's what. Alexbrn (talk) 22:02, 19 November 2021 (UTC)

Efficacy can be negative, that would mean that the vaccinated group was getting sick more than the control. But it is usually just an artefact of small sample sizes. We have a little bit of text on this at Vaccine efficacy, though it could use a source. MrOllie (talk) 23:19, 19 November 2021 (UTC)

I commented here. Axl ¤ [Talk] 10:34, 25 November 2021 (UTC)

The quantity (efficacy) can be negative; it is possible for a treatment to actually increase the risk. Many treatment candidates actually do, and many are simply not effective. The central estimate and its confidence interval ignore all other factors, so although you may be correct in saying it is "obviously wrong" because you are considering various other factors (how the body works, how mRNA works and how vaccines work, the fact that it works for other age groups, and so on), this number only considers events (case counts) and nothing else, so it is not reasoning about data, just a description of data. It helps reduce uncertainty, the complexities of the immune system are not fully understood, it give many surprises. And because the central estimate is quite high, I think that this is just a case of under-sampling. -Fernando Trebien (talk) 15:04, 12 December 2021 (UTC)

Extended-confirmed-protected edit request on 23 December 2021

There is a typo "judrisdictions" — qaisjp^{(talk) (contribs)} 18:16, 23 December 2021 (UTC)