AstraZeneca Covid-19 vaccine is ‘safe’

·6 min read

THE Department of Health in Central Visayas (DOH 7) assured the public and healthcare workers that the AstraZeneca vaccine against Covid-19 is safe and effective.

The Health Department’s regional office made the assurance after countries such as Germany, France, Italy and Spain temporarily suspended their use of the AstraZeneca vaccine following reports last week that there were inoculated individuals in Denmark and Norway who developed blood clots even if there was no proof that the blood clots were caused by the vaccine.

“DOH 7 still believes in its safety and efficacy. And while we wait for scientific results in the investigation of the causality of the said issues, let’s continue to be vaccinated,” said Dr. Mary Jean Loreche, DOH 7 spokesperson.

She also encouraged all medical workers inoculated with the AstraZeneca vaccine to conduct self-monitoring for any adverse events and to seek immediate consultation if they feel one.

The Perpetual Succour Hospital (PSH) in Cebu City started on Tuesday, March 16, its three-day inoculation with the AstraZeneca vaccine for its remaining 1,190 healthcare workers who did not receive the CoronaVac vaccine of Sinovac Biotech Ltd. The hospital received 238 vials of AstraZeneca vaccine last Saturday, March 13.

Also on Tuesday, March 16, a total of 40 police officers and medical personnel serving at the Philippine National Police (PNP)-Regional Health Service (RHS) 7 were inoculated with CoronaVac from the DOH 7.

RHS 7 head Lt. Col. Marilou Aboloc led the vaccination of the police’s medical personnel at the PNP hospital in Cebu City.

Aboloc said 101 RHS 7 personnel are scheduled for vaccination this week, with the last among them to get AstraZeneca jabs.

None of the over 10,000 personnel of the Police Regional Office 7 has refused vaccination, according to PRO 7 Director Ronnie Montejo.

Shipment

An additional shipment of 979,200 doses of the AstraZeneca vaccine may be delivered through the Covax initiative between next week and early April, vaccine czar Carlito Galvez Jr. said Monday evening, March 15, 2021.

Galvez told President Rodrigo Duterte he has been advised about the arrival of the additional vaccines on March 22 at the earliest.

Perpetual’s AZ rollout

Dr. Elrey Inocian, one of the medical personnel who led the PSH vaccination program, said majority, or 70 percent, of their healthcare workers will receive the AstraZeneca vaccine within the three-day inoculation period.

The hospital first vaccinated 600 healthcare workers (or 30 percent of its total target population for vaccination) with the CoronaVac last week.

Inocian said the 238 vials of AstraZeneca vaccine can already cover the two vaccine doses needed to complete the vaccination of the remaining 1,190 healthcare workers as each vial contains 5 milliliters (mL) of vaccine that is enough to vaccinate 10 people.

“We must be careful in aspirating that only 0.5 mL is extracted. If we exceed, even if it is only 0.6 mL, the dosage of the vaccine would be lacking,” he said.

(Aspiration is the term for the technique in drawing a vaccine or medicine into a syringe.)

To ensure this and to lessen the pressure or tension for the vaccinators, he said, they deployed two aspirators (who are assigned to extract 0.5 mL from the vial) and six other medical staff to do the actual vaccination.

Inocian said they have to inoculate 10 healthcare personnel before opening a new vial.

He said the vaccine should be given within five minutes upon extraction from its cold storage to maintain its potency or quality.

Unlike the CoronaVac that requires a 28-day wait for the second dose after the day a person receives his first dose of the Covid-19 vaccine, Inocian said those inoculated with AstraZeneca vaccines will wait for 56 days before they receive the second dose.

Priorities for the vaccination with AstraZeneca are the elderly healthcare workers.

Among them was Reynaldo Baclig, 79, a physician.

“Of course, there are side effects. It is just a matter of personal reactions, but basically, (there’s) nothing to be worried (about). Importante man gud nga (It’s important that) everybody should be vaccinated para (so) we can reduce the transmission,” he said.

PSH medical director Dr. Pureza Oñate, 75, said she really waited for the vaccine.

“I wanted to have Sinovac (the maker of CoronaVac), but because of my age, I could not get it kuno ingon ang mga batan-on nga doctor (the young doctors told me),” she said.

She added: “No one should be afraid because this can help people in preventing transmission.”

Dr. Ian Fruto Teodorico, PSH internist and allergic immunologist in-charge of the post-vaccination, said after receiving the vaccines, healthcare workers will be asked to stay for about 30 minutes as their vital signs will be monitored and they will be checked for any adverse events such as complaints of itching, allergies, or difficulty in breathing.

He said if there are no complaints, the healthcare workers will be discharged with the instruction that in the next four hours, they should observe for any onset of adverse reactions.

Aside from PSH, Loreche said four other hospitals have started their rollout of the AstraZeneca vaccine as of March 15. These are the Eversley Childs Sanitarium and General Hospital, 50 vials received; the Cebu Doctors’ University Hospital, 210 vials received; ARC Hospitals, 55 vials received; and Cebu City Medical Center, 60 vials received.

Scientific evidence

AstraZeneca assured that its Covid-19 vaccine is safe based on clear scientific evidence.

In a statement, the company said a careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and UK with Covid-19 vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country.

There have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine in the EU and UK, based on the number of cases the company has received as of March 8, 2021.

The company said this is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed Covid-19 vaccines.

The monthly safety report will be made public on the European Medicines Agency website in the following week, in line with exceptional transparency measures for Covid-19.

Furthermore, in clinical trials, even though the number of thrombotic events was small, these were lower in the vaccinated group. There has also been no evidence of increased bleeding in over 60,000 participants enrolled, the company added.

Quality

In terms of quality, there are also no confirmed issues related to any batch of AstraZeneca vaccine used across Europe, or the rest of the world.

During the production of the vaccine, more than 60 quality tests are conducted by AstraZeneca, its partners and by more than 20 independent testing laboratories.

All tests need to meet stringent criteria for quality control and this data is submitted to regulators within each country or region for independent review before any batch can be released to countries.

The AstraZeneca vaccine, formerly AZD1222, was co-invented by the University of Oxford and its spin-out company, Vaccitech.

The vaccine has been granted a conditional marketing authorization or emergency use in more than 70 countries across six continents. The recent emergency use listing granted by the World Health Organization accelerates the pathway to access in up to 142 countries through the Covax Facility. (WBS, AYB, SunStar Philippines)