www.biopharminternational.com eBook March 2021 BioPharm International 41
risk-based tools for implementing CCS
changes and comparability protocols.
FDA announced on Feb. 22, 2021
that it issued a suite of guidance doc-
uments to address the emergence of
variants of SARS-CoV-2. The guid-
ance documents include an update
to the October 2020 g uidance on
Emergency Use Authorization (EUA)
for vaccines to prevent COV ID-19,
guidance on the impact of the vari-
ants on monoclonal antibody (mAb)
products and other treatments, and a
guidance the impact of the variants on
COVID-19 tests (5).
The updated guidance, Emergency
Use A u th o r i z a t i o n f o r Va c c i n e s to
P revent COV I D -19, of fers recom-
mendat ions to vaccine developers
regarding virus variants, including
developers who already received EUA
for their vaccine. The agency stated, in
a press release, that FDA-authorized
vaccines are effective against the cur-
rent strains of SARS-CoV-2, but it
may be necessar y to tailor vaccines
should a new variant emerge in the
United States that is "moderately or
fully resistant to the antibody response
elicited by the current generation of
COVID-19 vaccines".
On Feb. 11, 2021, FDA published
g u ida nce t hat g ives recommenda-
tions to hea lth ca re prov iders and
investigators on the use of COVID-
19 conva lescent plasma or investi-
g at iona l conv a lescent pl a sma (6).
Recommendations are also provided
regarding blood collection. The doc-
ument a lso d iscusses t he agenc y 's
interim compliance and enforcement
policy for investigational new drug
requirements for the use of investiga-
tional convalescent plasma.
The new guidance, which super-
sedes g u ida nce issued in Ja nua r y
2021 and previous versions, includes
revised recommendations for conva-
lescent plasma donors. "The revisions
address when individuals who have
received an investigational COVID-
19 monoclonal antibody therapy as
a par ticipant in a clinica l tria l, or
received an authorized or licensed
COV I D -19 monoc lona l a nt ibody
t he r ap y, q u a l i f y a s c onv a l e s c e nt
plasma donors," the guidance states.
REFERENCES
1. J. Wechsler, PharmTech 45 (3) 2021.
2. CDER, CDER Guidance Agenda
New & Revised Draft Guidance
Documents Planned for Publication
in Calendar Year 20211 (January
2021), FDA.gov.
3. CBER, Guidance Agenda:
Guidance Documents CBER
is Planning to Publish During
Calendar Year 2021, FDA.gov.
4. FDA, COVID-19 Container Closure
System and Component Changes:
Glass Vials and Stoppers Guidance for
Industry (CBER, CDER, March
2021).
5. FDA, "Coronavirus (COVID-19)
Update: FDA Issues Policies to
Guide Medical Product Developers
Addressing Virus Variants," Press
Release, Feb. 22, 2021
6. FDA, Investigational COVID-19
Convalescent Plasma Guidance for
Industry (CBER, Feb. 11, 2021) BP
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