Document text
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Module 1.11.1 Response to 20 May 2021 F DA IR–Manufacturing Schedules & Precautions
PFIZER CONFIDENTIAL
Page 1QUERY 1
Please submit an updated manufacturing schedule for June 1 through October 31, 2021, that
details upstream and downstream operations for BNT162b2 drug substance manufacturing in
both and at Wy eth BioPharma Division of WyethPharmaceuticals LLC
facility(FEI: 1222181) in Andover, MA in support of BLA 125742/0.
RESPONSE 1
Andover:
The production of the BNT162b2 drug substance includes
through final dispenseof the drug substance .
will be in active production from 01 June 2021through 31 October 2021 , except for
04 July 2021through 10 July 2021due to summer holiday for the associated personnel.
will be in active production from 01 June 2021through 31 October 2021 , except for
04 July 2021through 10 July 2021due to summer holiday for the associated personnel.
to support future BNT162b2 drug substance production demands ,in
arecurrently anticipated to occur between 01 June 2021and 04 June 2021and then from 19
July 2021through07 August 2021. The production schedule is d ynamic and subject to
change.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
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FDA-CBER-2021-5683-1149297
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Module 1.11.1 Response to 20 May 2021 F DA IR–Manufacturing Schedules & Precautions
PFIZER CONFIDENTIAL
Page 2QUERY 2
Please submit an updated manufacturing schedule for June 1 through October 31, 2021, that
details lipid nanoparticle formulation and fill/finish operations for BNT162b2 drug product
manufacturing at both Pfizer Manufacturing Belgium NV facility (FEI: 1000654629)
inPuurs, Belgium and Pharmacia & Upjohn Company LLC. facilit y (FEI: 1810189) in
Kalamazoo, MI in support of BLA125742/0. Please include production schedules for each
filling line.
RESPONSE 2
Kalamazoo:
Kalamazoo will be in active production of BNT162b2 in all L NP formulation areas, filling
lines (Line ), and packaging lines f rom 01June 2021to 31 October 2021with no
planned facility or production shutdowns. An additional area supporting LNP formulation for
emergency use and eventual licensure will be available from 26 July 2021to 31 October
2021.
Puurs:
Puurs will be in ac tive production of BNT162b2 in variousLNP formulation areas, filling
lines ),and packaging lines from 01 June 2021 to 31 October 2021. However,
production activities are reduced starting from 05 July 2021until 05 September2021, due to
scheduled in the formulation booths and f illing lines.
Additional details are provided in the response to Query 3.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e1971b72c4\Approved\Approved On: 24-May-2021 13:15 (GMT)
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FDA-CBER-2021-5683-1149298
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Module 1.11.1 Response to 20 May 2021 F DA IR–Manufacturing Schedules & Precautions
PFIZER CONFIDENTIAL
Page 3QUERY 3
Please provide clarification regarding of the Puurs, Belgium facility.
As noted in the BLA Section 3.2.R Manufacturing Schedules, production of the COVID -19
vaccine may not be occurring during these timeframes: May 31, 2021, –June 06, 2021, and
July 10, 2021 , –Sept 06, 2021. Please provide clarification if this applies to all COVID -19
vaccine manufacturing (formulation and/or fill/finish) or select operations.
RESPONSE 3
An audit by the Belgian health authority (FAGG)has been scheduled from 31 May 2021 to
06 June 2021. Therefore, while BNT162b2 production will occur during this time period, it
was indicated as not preferable .
In addition, d ue to
during July and August, BNT162b2production
including production in some manufacturing areas producing BNT162b 2COVID-19
Vaccine, but not include d in the BLA (see Table 1 and Figure 1below).Finally, the period
priorto, during, and immediatel yfollowing are scheduled as summer holiday s
for associated personnel (including man yBNT162b2 subject matter experts (SMEs)).
A detailed shutdown schedule is providedin Table 1 and Figure 1 below.
090177e1971b72c4\Approved\Approved On: 24-May-2021 13:15 (GMT)
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FDA-CBER-2021-5683-1149299
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Module 1.11.1 Response to 20 May 2021 F DA IR–Manufacturing Schedules & Precautions
PFIZER CONFIDENTIAL
Page 4Table 1.Shutdown Versus Active Manufacturing at Pfizer Puurs
Manufacturing Activity Manufacturing Area Shutdown* Active Manufacturing
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FDA-CBER-2021-5683-1149300
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Module 1.11.1 Response to 20 May 2021 F DA IR–Manufacturing Schedules & Precautions
PFIZER CONFIDENTIAL
Page 5Figure 1: Shutdown Versus Active Manufacturing at Pfizer Puurs
As indicated above, the availability of BNT162b2 SMEs on site during this period is strongl y aligned with the production sche me.
Therefore, the Puurs site will bemanufacturing BNT162b2 at full capacit y from 01 Jun 2021 until 05 July 2021, and again start ing
from 06 September 2021 through 31 October 2021 .
Literature References
None
SUPPORTING DOCUMENTATION
None
090177e1971b72c4\Approved\Approved On: 24-May-2021 13:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149301
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Module 1.11.1 Response to 20 May 2021 F DA IR–Manufacturing Schedules & Precautions
PFIZER CONFIDENTIAL
Page 6QUERY 4
Please provide the COVID -19 precautions taken at each manufacturing facility related to
visitor entry requirements. At a minimum, please include the maximum number of
visitors/inspectors and the necessity of vaccine status/negative COVID -19 test result for
entry into your facilit y.
RESPONSE 4
Andover and Kalamazoo:
All visitors to the U.S. Pfizer sites must adhere to the st ate restrictions and guidelines. The
current COVID -19 information for each state can be found by accessing the following links:
Massachusetts: https://www.mass.gov/info -details/covid -19-updates-and-information
Michigan: https://www.michigan.gov/coronaviru s/
In addition, all visitors to the Pfizer Andover and Pfizer Kalamazoo sites must follow Pfizer
restrictions and guidelines to ensure the safet y of those on site. There is no requirement
regarding COVID -19 vaccination or to produce a negative COVID -19 test result. However,
Pfizer site requirements are more restrictive than the state orders regarding screening
questions, s ocial distancing, and hygienepractices, as well as contact tracing as noted below .
There are no maximum number of visitors to the site , however, due to reduced room
capacities due to COVID -19 restrictions, which are strictly enforced, sites limit the number
of visitors to ensure social distancing. Conference rooms are at a reduced capacity with table
decals denoting6’ social distancing space. Pfizer would also like to ensure an inspection can
be supported effectively given the pandemic requirements and therefore would like this to be
considered.
Screening questions will be required to be addressed by all visitors up on arrival at the site. If
the answer to an y of the questions is “yes ,”you will be asked to contact your host and talk
with the Pfizer nurse practitioner. Precautions and protocols to be followed while on site are
also included below.
1.Screening questions (Please answer Yes or No)
Have you travelled internationally in the past 14 days?
Are you feeling unwell currentl y?
Have you had an y symptoms of influenza like illness (ILI) in the past 14 day s?
Have you been in contact with anyone confirmed/presumed to have COVID-19 or ILI
in the past 14 day s?
2.While on site, Pfizer has implemented the following precautions and protocols:
The following must be followed:
oSocial distancing and h ygiene practices
Planon maintaining social distance at all times on site (6ft from others)
090177e1971b72c4\Approved\Approved On: 24-May-2021 13:15 (GMT)
FDA-CBER-2021-5683-1149302
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Module 1.11.1 Response to 20 May 2021 F DA IR–Manufacturing Schedules & Precautions
PFIZER CONFIDENTIAL
Page 7If close work is required (<6ft), the host must perform social distance risk
assessment to determine appropriate control (e.g., barriers) or added PPE
(Personal Protection Equipment) (e.g.,face shield in addition to mask).
Mask wearing is required unless eating or drinking.
Mask wearing outside is waived as long as social distancing can be
maintained (>6ft).
Mask to be worn upon exiting vehicle once arriving on site unless social
distancing can be maintained from others (>6ft).
Avoid touching face or exterior of mask.
Hand washing/sanitizing must occur frequently.
oPlease note that contacttracing must be recorded daily while on site, even if no
contacts are identified. Your host will be responsible for confirming completion
and assure the location where the majority of time spent (e.g. room number) is
documented.
The Pfizer sites are continually monitoring data from the surrounding areas and assessing the
situation. Any changes to the above restrictions and policies will be communicated.
Puurs:
The COVID-19 precautions to be taken are dependent on the guidelines from the Belgian
Authorities at the time of visit and are updated daily .Every visitor coming by planeshould
fill in a Passenger Locator Form (PLF), specific requirements depend on the colorcode of
your country . At the moment, the United States is indicated as a ‘red zone’, therefore, a
negative PCR- test is required for an y stay longer than 48 hours ( test result not older than 72
hours before departure). A quarantine of 7 day s isrequired with the exception of the visit on
site.More information can be found at the official Belgian website ‘https://www.info-
coronavirus.be/en/colour -codes-by-country/’ and in the document s provided(Guidelines f or
Business T ravel from a Red Zone to Belgium andRequirements for Travel to Belgium ).
In addition, visitor access at Pfizer, Puurs is only possible if the following questions can be
answered as ‘No’. In case the answer to any of thesequestions is ‘y es’, the visit will be
rescheduled.
Question Response
Have you been on holiday for more than 48 hours in a country which,
according to the websiteaof the Belgian government, is a dark
orange or red zone?Yes or No
Have you or a member of y our household been in contact over the last 14
days with any one who has been diagnosed with COVID -19?Yes or No
Are you or a member of your household currently waiting for the result of
a COVID -19 test? Yes or No
Are you currentl y unwell, with symptoms including fever, high
temperature, cough, or sore throat?Yesor No
a. https://www.info -coronavirus.be/en/colour -codes-by-country/
090177e1971b72c4\Approved\Approved On: 24-May-2021 13:15 (GMT)
FDA-CBER-2021-5683-1149303
COVID-19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Module 1.11.1 Response to 20 May 2021 F DA IR–Manufacturing Schedules & Precautions
PFIZER CONFIDENTIAL
Page 8For non-residents travelling to Belgium from a red zone , the questions below in the
declaration should be answered as ‘OK’and signed for agreement upon arrival on site .
Declaration Signed in agreement:
OKNOK Name of compan y:
I have the certificate for the exception to
quarantine for critical functions and have evidence
of this☐ ☐ Surname and first
name:
OKNOKNA
My stay in Belgium is less than 48 hrs and my
transport is not by boat or plane, I do not need a
PCR-test and PLF form.☐ ☐ ☐Signature:
My stay in Belgium is less than 48 hrs and my
transport is by boat or plane, I’ve completed and
submitted a PL F(Passenger Locator Form) and
have evidence of this.☐ ☐ ☐
My stay in Belgium is longer than 48 hrs, I’ve
completed and submitted a PLF (Passenger Locator
Form) and have evidence of this.☐ ☐ ☐
I have evidence of a recent negative PCR test result
(i.e.less than 72 hours old).☐ ☐ ☐
All visitors to the Pfizer Puurs site must follow Pfizer restrictions and guidelines regarding
social distancing, h ygiene and masks to ensure the safet y of those on site. There are no
maximum number of visitors to the site, however, due to reduced room capacities due to
COVID-19 restrictions, which are strictly enforced, sites limit the number of visitors to
ensure social distancing. Conference rooms are at a reduced capacit y with table decal s
denoting 1.5 m social distancing space. Pfizer would also like to ensure an inspection can be
supported effectivel y given the pandemic requirements and therefore would like this to be
considered.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
3.2.R Guidelines f orBusiness Travel from a Red Zone to Belgium , new
3.2.R Requirements for Travel to Belgium , new
Previously submitted supporting documentation
None
090177e1971b72c4\Approved\Approved On: 24-May-2021 13:15 (GMT)
FDA-CBER-2021-5683-1149304