WHO’s Strategic Advisory Group of
Experts on Immunization (SAGE) has issued its policy recommendations for the
rollout of the first COVID-19 vaccine approved
for emergency use, the Pfizer-BioNTech COVID-19 vaccine.
According
to SAGE, the Pfizer-BioNTech COVID-19 mRNA vaccine is safe and effective. Nevertheless,
there are specific populations for whom vaccination is not recommended, either
due to contraindications, lack of supply, or limited data. These
populations currently include people with a history of severe allergies, most
pregnant women, international travellers who are not part of a prioritized
group, and children under 16.
The
priority is to start vaccinating health workers at high risk of exposure,
followed by older adults, before immunizing the rest of the population.
People
with allergies
People
with a history of severe allergic reaction to any component of the vaccine
should not take it.
Pregnant
and breastfeeding women
Pregnant women
are at higher risk of severe COVID-19 than non-pregnant women, and COVID-19 has
been associated with an increased risk of pre-term birth.
However
due to insufficient data, WHO does not recommend the vaccination of pregnant
women at this time.
In case a
pregnant woman has an unavoidable risk high of exposure (e.g. a health worker),
vaccination may be considered in discussion with their healthcare provider.
It is
recommended to avoid pregnancy for 2 to 3 months post-vaccination.
If a
breastfeeding woman is part of a group (e.g. health workers) recommended for
vaccination, vaccination can be offered. WHO does not recommend discontinuing
breastfeeding after vaccination.
Children
The
vaccine has only been tested in children above 16 years of age.
Therefore,
at this time, WHO does not recommend vaccination of children below 16 years of
age, even if they belong to a high-risk group.
People
with known medical conditions
The
vaccine has been found to be safe and effective in people with various conditions
that are associated with increased risk of severe disease.
This
includes hypertension, diabetes, asthma, pulmonary, liver or kidney disease, as
well as chronic infections that are stable and controlled.
Further
studies are required for the impacts on immune-compromised persons. The interim
recommendation is that immune-compromised persons who are part of a group
recommended for vaccination may be vaccinated, though when possible, not before
receiving information and counselling.
Persons
living with HIV are at higher risk of severe COVID-19 disease. Limited safety
data exists on HIV-infected persons with well controlled disease from the
clinical trials. Known HIV-positive vaccine recipients should be informed, and
when possible, counselled in relation to the available data.
People
who have or had COVID-19 already
Vaccination
can be offered to people who have had COVID-19 in the past.
But given the
limited vaccine supply, individuals may wish to defer their own COVID-19 vaccination
for up to 6 months from the time of SARS-CoV-2 infection. As more data
becomes available on duration of immunity after infection, this time period may
be adjusted.
Testing
for prior infection is not recommended for the purpose of vaccine
decision-making.
Travellers
At present, WHO does not support the introduction of
requirements for proof of vaccination against COVID-19 for international
travelers as a condition for exiting or entering a country or for travelling
internationally. See WHO’s interim guidance on international travel during
the pandemic.
Dosage
A
protective effect starts to develop 12 days after the first dose, but full
protection requires two doses which WHO recommends be administered with a 21 to
28-day interval. Additional research is needed to understand longer-term
potential protection after a single dose.
Vaccines
will not end COVID-19 alone
Safe and
effective vaccines will be a gamechanger: but for the foreseeable future we
must continue to wear masks, physically distance, avoid crowds and apply other
health measures. Being vaccinated doesn’t mean that we can throw caution to the
wind and put ourselves and others at risk, particularly because it is still not
clear the degree to which the vaccines can protect not only against disease but
also against infection and transmission.
What
about other vaccines being developed to fight COVID-19
WHO does
not usually make vaccine specific recommendations, issuing instead one
recommendation that covers all vaccines for a given disease, unless the
evidence suggests a different approach is required.
Due to the
large variety of COVID-19 vaccines based on very different platform
technologies, WHO is looking at vaccines are they are being authorised
by highly competent national regulatory authorities and that are available in
sufficient supply to address the needs of many countries.
WHO has no
preferred product, and the variety of products, including their specific
attributes and handling requirements, allow for countries to find the products
that are most suitable for their circumstances.
WHO’s SAGE
is expected to review other vaccines in the coming months.
