Everything you need to know about Sinopharm's COVID-19 vaccine

Update of September 2, 2021, in accordance with the updated interim recommendations

The WHO Strategic Advisory Group of Experts on Immunization (SAGE) has published interim recommendations on the use of the BBIBP-CorV vaccine against COVID-19 manufactured by Sinopharm/China National Pharmaceutical Group.

This article provides a summary of these interim recommendations. The full document is available online along with the background document.

Here are the basics you should know about it.

Who should be vaccinated first?

While supplies of COVID-19 vaccines are limited, health care workers at high risk of exposure and old people.

Administering this vaccine to children under 18 years of age is not recommended, subject to studies that provide results for this age group.

Countries can refer to the WHO Roadmap for Priority Setting and the WHO Values ​​Framework for prioritizing target groups.

Should pregnant women be vaccinated?

There are insufficient data on the administration of the BBIBP-CorV vaccine to pregnant women to assess its efficacy and the risks it may expose. However, it is an inactivated virus vaccine that contains an adjuvant commonly used in other vaccines and does not cause toxicity problems in vaccinated people, including pregnant women. It is expected that the efficacy of this vaccine in pregnant women is similar to that in pregnant women of the same age.

For the time being, the WHO recommends administering this vaccine to pregnant women whenever the benefits of vaccination outweigh the potential risks involved. In order for clients to make an informed decision to be vaccinated, they should be provided with information about the risks of COVID-19 for pregnancy, the potential benefits of vaccinating taking into account the local epidemiological context, and current limitations regarding vaccinations. safety data in pregnant women. The WHO does not recommend the practice of carrying out pregnancy tests before administering this vaccine, nor does it recommend delaying pregnancy or terminating a pregnancy due to vaccination.

Who else can get vaccinated?

The vaccine can be offered to people who have had COVID-19. The available data indicate that symptomatic reinfection after 6 months of a non-vaccine primary infection is rare. In places where there are indications that variants of SARS-CoV-2 of concern exist that escape the action of the immune system, it may be advisable to immunize those infected early.

Efficacy of the BBIBP-CorV vaccine in lactating women is expected to be similar to that seen in other adults. The WHO recommends administering it to breastfeeding women, as well as other adults, and advises against interrupting breastfeeding after vaccination.

People infected with HIV are at higher risk of developing a severe form of COVID-19. The trial of this vaccine did not include HIV-infected people, but since it does not contain a virus that can replicate, such people are included in the group for which it is recommended. However, they should be offered information and advice, whenever possible, so that they are aware of the benefits and risks of vaccination.

Who is the vaccine not recommended for?

People who have had a severe allergic reaction to any component of this vaccine should not be vaccinated.

In addition, vaccination should be postponed for anyone with a body temperature above 38.5°C until the fever is gone.

What dosage is recommended?

SAGE recommends administering two 0.5 mL doses of this vaccine intramuscularly, 3 to 4 weeks apart. It is not necessary to repeat the administration of the second dose if it is accidentally applied before three weeks have elapsed from the first. In the event that more than 4 weeks have passed after the first dose, the second dose should be administered as soon as possible. Both doses should be administered to all vaccinated persons.

What differences does this vaccine have with others that are already being used?

Although the differences in the conception of the studies make it impossible to compare two vaccines with each other, it can be affirmed that, in general, all vaccines included by WHO in the emergency use list are very effective in preventing severe COVID-19 and hospitalization for this disease.

Is this vaccine safe?

SAGE has thoroughly reviewed the data on the vaccine's quality, safety, and efficacy and has recommended its use in people 18 years of age and older.

There are few data available on the safety of this vaccine in people older than 60 years, due to the small number of participants in clinical trials. Although it cannot be anticipated that there will be differences in the safety profile of the vaccine in older adults compared to younger age groups, countries considering administering this vaccine to persons older than 60 years should remain vigilant for possible side effects. adverse.

Is the vaccine effective?

A large international phase III trial has shown that the administration of two doses of this vaccine 21 days apart protects with 79% efficacy against symptomatic SARS-CoV-2 infection 14 days or more after the second dose administration date. Regarding the prevention of hospitalization, the efficacy of the vaccine was 79%.

The trial was not designed to demonstrate efficacy of the vaccine against severe symptoms in people with comorbidities, pregnant women, and adults 60 years of age and older. Furthermore, women were proportionally underrepresented. Subjects had been followed for an average of 112 days at the time the trial results were analysed.

Two other trials are underway to test the efficacy of this vaccine, but no data have yet been obtained.

Is it effective against new variants of SARS-CoV-2?

SAGE currently recommends using this vaccine, based on the WHO Roadmap for priority setting.

As new data becomes available, WHO will update the recommendations accordingly. The use of the vaccine in places where variants of SARS-CoV-2 of concern are in circulation has not yet been studied.

Does it prevent infection and transmission?

There are no comprehensive data on the effect of the BBIBP-CorV vaccine on the transmission of SARS-CoV-2.

For now, we must maintain and reinforce the public health measures that work: wear a mask, maintain physical distancing, practice hand washing, maintain cough and respiratory hygiene, avoid crowds, and ventilate well.