What you need to know
What you need to know

What you need to know

Updated January 21, 2022 according to updated preliminary recommendations

The WHO Strategic Advisory Group of Experts on Immunization (SAGE) has issued preliminary recommendations for the use of the Pfizer BioNTech (BNT162b2) vaccine against COVID-19. This article provides a summary of these preliminary recommendations; you can access the entire guide here.

Here’s what you need to know.

According to SAGE, the Pfizer-BioNTech COVID-19 mRNA vaccine is safe and effective. The priority is to start vaccinating high-risk healthcare workers, followed by older adults, before vaccinating the rest of the population.

Who should be vaccinated first?

Although vaccine supplies are limited, it is recommended to prioritize high-risk healthcare professionals and the elderly, including those aged 65 or over.

Countries can refer to WHO roadmap for prioritization and WHO Values ​​Framework as a guide for their prioritization of target groups.

Who else can take the vaccine?

The vaccine has been shown to be safe and effective in people with various conditions associated with an increased risk of serious illness.

This includes hypertension, diabetes, asthma, lung, liver or kidney disease, as well as chronic infections that are stable and controlled.

Given the significant risk of severe COVID-19 in moderately or severely immunocompromised individuals (ICPs), the WHO recommends an extended (3 doses) primary series based on available data, although individual safety monitoring is required, as is consultation with the attending physician.

People living with HIV are at higher risk for severe COVID-19 disease. Limited safety data on HIV-infected individuals with well-controlled disease are available from clinical trials. Known HIV-positive vaccine recipients should be informed and, where possible, advised against the available data.

Vaccination can be offered to people who have previously had COVID-19. However, given the limited vaccine supply, individuals may wish to delay their own COVID-19 vaccination for up to 6 months from the time of SARS-CoV-2 infection. However, circulating variants of concern should be taken into account. In such situations, prior immunization after infection is advisable, e.g. within 90 days after natural infection.

Vaccine efficacy is expected to be the same in lactating women as in other adults. The WHO recommends the use of the vaccine in lactating women as in other adults. WHO does not recommend stopping breastfeeding due to vaccination.

Should pregnant women be vaccinated?

Given the negative consequences of COVID-19 disease during pregnancy and the increasing data supporting a favorable safety profile for BNT162b2 during pregnancy, the WHO recommends the use of BNT162b2 in pregnant women. WHO does not recommend pregnancy testing before vaccination. The WHO does not recommend postponing the pregnancy or terminating the pregnancy due to vaccination.

Who should not take the vaccine?

People with a history of severe allergic reaction to any component of the vaccine should not take it.

Is this vaccine recommended for children and adolescents?

This vaccine is safe to use for people aged 5 and over, with an adjustment of the recommended dose for those aged 5-11 years.

A phase 3 trial with children aged 12-15 years showed high efficacy and good safety in this age group, leading to an extension of the previous age indication from 16 years down to 12 years and above. A phase 3 trial in children aged 5-11 showed similar immune response and safety results.

The WHO recommends that countries should only consider using the vaccine for children aged 5 to 17 years when high vaccine coverage has been achieved with 2 doses in the high-priority groups as identified in the WHO’s priority roadmap.

Children and adolescents aged 5-17 years with comorbidities that put them at significantly higher risk of severe COVID-19 disease should be offered vaccination along with other high-risk groups.

What is the recommended dose?

A protective effect begins to develop 12 days after the first dose, but full protection requires two doses recommended by the WHO at intervals of 21 to 28 days. Further research is needed to understand long-term potential protection after a single dose. It is currently recommended that the same product be used for both doses whenever possible.

SAGE recommends that people with severe and moderate immune compromise be offered an extra dose of vaccine as part of the primary series. This is due to the fact that this group is less likely to respond adequately to vaccination after a standard primary vaccination series and has a higher risk of severe COVID-19 disease.

Studies have shown a high impact on public health, where the range has been longer than recommended by the EUL. Accordingly, countries facing a high prevalence of COVID-19 combined with severe vaccine supply constraints may consider postponing the second dose for up to 12 weeks to achieve a higher initial dose coverage in high-priority populations.

Is a booster dose recommended for this vaccine?

A booster dose can be considered 4 – 6 months after the end of the primary vaccination series, although this is mainly recommended for the high-priority user groups in accordance with the WHO’s priority roadmap.

The benefits of booster vaccination have been recognized following increasing evidence of diminishing vaccine efficacy against mild and asymptomatic SARS-CoV-2 infection over time.

The need and timing of booster doses for children aged 5-11 years have not yet been determined.

Can this vaccine be ‘mixed and matched’ with other vaccines?

SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series.

For countries considering heterologous schemes, the WHO has made recommendations to ensure equivalent or favorable immunogenicity or vaccine efficacy for heterologous versus homologous schemes:

  • One of the WHO EUL COVID-19 vectored vaccines (Janssen or AstraZeneca Vaxzervia / COVISHIELD) can be used as a second dose after a first dose of the Pfizer vaccine, depending on the availability of the product.
  • The Pfizer vaccine can also be used as one second dose after any of the WHO EUL COVID-19 inactivated vaccines (Sinopharm, Sinovac or Bharat) or any of the vectored vaccines (Janssen or AstraZeneca Vaxzervia / COVISHIELD)

Is it safe?

The Global Advisory Committee on Vaccine Safety (GACVS), a group of experts providing independent and authoritative guidance to the WHO on the subject of safe vaccine use, receives and assesses reports of suspected safety incidents with potential international impact. In October 2021, the GACVS COVID-19 subcommittee concluded that the mRNA COVID-19 vaccines have clear benefits in all age groups by reducing hospitalizations and deaths due to COVID-19.

How effective is the vaccine?

The Pfizer BioNTech vaccine against COVID-19 has a 95% efficacy against symptomatic SARS-CoV-2 infection.

Does it work against new varieties?

SAGE has reviewed all available data on the vaccine’s performance in tests to assess efficacy against a range of variants. These tests indicated that the vaccine was effective against virus variants, but for the Omicron variant, the efficacy of the vaccine against severe and mild disease after two doses is lower compared to Delta, and decreasing is faster.

SAGE currently recommends the use of the Pfizer BioNTech vaccine according to the WHO’s priority roadmap, even though virus variants are present in a country. Countries should assess risks and benefits, taking into account their epidemiological situation.

Preliminary results highlight the urgent need for a coordinated approach to monitoring and evaluating variants and their potential impact on vaccine efficacy. As new data becomes available, the WHO will update the recommendations accordingly.

Does it prevent infection and transmission?

There is currently insufficient evidence available related to the effect of Pfizer BioNTech vaccine on transmission or viral excretion.

In the meantime, we must maintain and strengthen public health measures that work: masking, physical distancing, hand washing, respiratory and cough hygiene, avoiding crowds and ensuring good ventilation.

How is this vaccine compared to other COVID-19 vaccines in use?

It is impossible to compare vaccines among themselves due to the different approaches taken in the design of the respective studies, but overall, all the vaccines that have achieved the WHO’s emergency use list are extremely effective in preventing serious disease and hospitalization due to COVID- 19.

This web page was updated on January 19, 2022 to include the latest guidance.

This website was updated on January 5, 2022 to update the latest guidance and ensure consistency in information and formatting.

This website was updated on April 20, 2021 to ensure consistency in information and formatting.

This article was corrected on January 12, 2021 to remove an incorrect reference regarding pregnancy. The WHO does NOT recommend that pregnancy be avoided after vaccination.

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