https://www.pfizer.com/news/announcements/pfizer-responds-research-claims#.Y9WTkZsflV4.mailto

This is Pfizers resoponse for events since the the totally save and
effective vaccines. Still not a total admittance but a bit more time might
get us closer.

Not the date of this response. 27 January 2023, some 2.5 months after the testing of the vaccine. One would have thought that some of these would have been known right after the testing.

Note the wording

"The vaccine may not protect everyone".

This response is something one would have expecet after the testing phase,
not two years later.

If you are in a hurry, skip down to "IMPORTANT SAFETY INFORMATION"



Quote

Pfizer Responds to Research Claims
Friday, January 27, 2023 - 08:00pm
Share
New York, N.Y., January 27, 2023 – Allegations have recently been made related
to gain of function and directed evolution research at Pfizer and the company would like to set the record straight.

In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer
has not conducted gain of function or directed evolution research.
Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new
variants of concern. This work is undertaken once a new variant of
concern has been identified by public health authorities. This research provides a way for us to rapidly assess the ability of an existing
vaccine to induce antibodies that neutralize a newly identified variant
of concern. We then make this data available through peer reviewed scientific journals and use it as one of the steps to determine whether a vaccine
update is required.

In addition, to meet U.S. and global regulatory requirements for our
oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., in a laboratory culture dish) to identify potential resistance mutations to nirmatrelvir, one of PAXLOVID’s two components. With a naturally
evolving virus, it is important to routinely assess the activity of an antiviral. Most of this work is conducted using computer simulations
or mutations of the main protease–a non-infectious part of the virus.
In a limited number of cases when a full virus does not contain any
known gain of function mutations, such virus may be engineered to
enable the assessment of antiviral activity in cells. In addition,
in vitro resistance selection experiments are undertaken in cells
incubated with SARS-CoV-2 and nirmatrelvir in our secure Biosafety
level 3 (BSL3) laboratory to assess whether the main protease can
mutate to yield resistant strains of the virus. It is important
to note that these studies are required by U.S. and global regulators
for all antiviral products and are carried out by many companies and
academic institutions in the U.S. and around the world.

Fact-based information rooted in sound science is vitally important
to overcoming the COVID-19 pandemic and Pfizer remains committed
to transparency and helping alleviate the devastating burden of
this disease.


U.S. INDICATION & AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)

AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
is FDA authorized under Emergency Use Authorization (EUA) for
use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either:

• completion of primary vaccination with any authorized or
approved monovalent* COVID-19 vaccine; or
• receipt of the most recent booster dose with any
authorized or approved monovalent* COVID-19 vaccine

*Monovalent refers to any authorized and approved COVID-19 vaccine
that contains or encodes the spike protein of only the Original
SARS-CoV-2 virus.

COMIRNATY® (COVID-19 Vaccine, mRNA)

INDICATION
COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19
vaccine for active immunization to prevent coronavirus disease 2019
(COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

AUTHORIZED USE
COMIRNATY® (COVID-19 Vaccine, mRNA) is authorized under
Emergency Use Authorization (EUA) to provide:

Primary Series
• a third primary series dose to individuals 12 years of age
and older who have certain kinds of immunocompromise

Pfizer-BioNTech COVID-19 Vaccine

AUTHORIZED USES

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency
Use Authorization (EUA) for use in individuals 6 months and older to provide:

Primary Series

• a 2-dose primary series to individuals 5 years of age and older
• a third primary series dose to individuals 5 years of age and
older with certain kinds of immunocompromise

Pfizer-BioNTech COVID-19 Vaccine and
Pfizer-BioNTech COVID-19 Vaccine, Bivalent

AUTHORIZED USES

Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine,
Bivalent are FDA authorized under Emergency Use Authorization (EUA)
for use in individuals 6 months to 4 years of age to provide:

Primary Series

• a 3-dose primary series as follows:
o Dose 1: Pfizer-BioNTech COVID-19 Vaccine
o Dose 2: Pfizer-BioNTech COVID-19 Vaccine
o Dose 3: Pfizer-BioNTech COVID-19 Vaccine, Bivalent

EMERGENCY USE AUTHORIZATION

Emergency uses of the vaccines have not been approved or licensed
by FDA but have been authorized by FDA under an Emergency Use
Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19)
in individuals aged 6 months and older. The emergency uses are only
authorized for the duration of the declaration that circumstances
exist justifying the authorization of emergency use of the medical
product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.

IMPORTANT SAFETY INFORMATION

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and
Omicron BA.4/BA.5), COMIRNATY® (COVID-19 Vaccine, mRNA),
and Pfizer-BioNTech COVID-19 Vaccine

Tell your vaccination provider about all of your medical conditions,
including if you:

• have any allergies
• have had myocarditis (inflammation of the heart muscle) or
pericarditis (inflammation of the lining outside the heart)
• have a fever
• have a bleeding disorder or are on a blood thinner
• are immunocompromised or are on a medicine that
affects the immune system
• are pregnant, plan to become pregnant, or are breastfeeding
• have received another COVID-19 vaccine
• have ever fainted in association with an injection

• The vaccine may not protect everyone

• You should not get COMIRNATY (COVID-19 Vaccine, mRNA),
the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech
COVID-19 Vaccine, Bivalent if you have had a severe allergic reaction
after a previous dose of COMIRNATY or the Pfizer-BioNTech COVID-19 Vaccine
or any ingredient in these vaccines

• There is a remote chance that these vaccines could cause a severe allergic reaction. A severe allergic reaction would usually occur
within a few minutes to 1 hour after getting a dose of the vaccine.
For this reason, your vaccination provider may ask you to stay
at the place where you received the vaccine for monitoring after
vaccination. If you experience a severe allergic reaction, call
9-1-1 or go to the nearest hospital

Seek medical attention right away if you have any of the
following symptoms:

• difficulty breathing, swelling of the face and throat,
a fast heartbeat, a bad rash all over the body,
dizziness, and weakness

• Myocarditis (inflammation of the heart muscle) and
pericarditis (inflammation of the lining outside the heart)
have occurred in some people who have received COMIRNATY®
(COVID-19 vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine.
The observed risk is higher among adolescent males and adult
males under 40 years of age than among females and older males,
and the observed risk is highest in males 12 through 17
years of age. In most of these people, symptoms began within a
few days following receipt of the second dose of vaccine.
The chance of having this occur is very low

• Side effects that have been reported with these vaccines include:

• Severe allergic reactions
• Non-severe allergic reactions such as rash, itching,
hives, or swelling of the face
• Myocarditis (inflammation of the heart muscle)
• Pericarditis (inflammation of the lining outside the heart)
• Injection site pain
• Tiredness
• Headache
• Muscle pain
• Chills
• Joint pain
• Fever
• Injection site swelling
• Injection site redness
• Nausea
• Feeling unwell
• Swollen lymph nodes (lymphadenopathy)
• Decreased appetite
• Diarrhea
• Vomiting
• Arm pain
• Fainting in association with injection of the vaccine
• Unusual and persistent irritability
• Unusual and persistent poor feeding
• Unusual and persistent fatigue or lack of energy
• Unusual and persistent cool, pale skin
• Dizziness


These may not be all the possible side effects of these vaccines.

Call the vaccination provider or healthcare provider about
bothersome side effects or side effects that do not go away.

• Individuals should always ask their healthcare providers for
medical advice about adverse events. Report vaccine side effects to
the US Food and Drug Administration (FDA) and the Centers for
Disease Control and Prevention (CDC) Vaccine Adverse Event
Reporting System (VAERS). The VAERS toll-free number is
1‐800‐822‐7967 or report online to
www.vaers.hhs.gov/reportevent.html. In addition, individuals
can report side effects to Pfizer Inc. at
www.pfizersafetyreporting.com or by calling 1-800-438-1985

Unquote

--- SoupGate-Win32 v1.05
* Origin: fsxNet Usenet Gateway (21:1/5)